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Harušinec, Jozef, Andrej Suchánek, and Mária Loulová. "Creation of prototype 3D models using RAPID PROTOTYPING." MATEC Web of Conferences 254 (2019): 01013. http://dx.doi.org/10.1051/matecconf/201925401013.
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The article deals with creating 3D models using RAPID PROTOTYPING technology. At present, we are witnessing the integration of new technologies into ordinary life. A good example is the use of FDM (fused deposition modeling) technology that primarily uses thermoplastics to create 3D models. A few years ago, the use of rapid prototyping technology was a prerogative of companies, research institutes and a narrow group of universities. Technologies such as FDM and STL (Stereolithography) have become affordable in the past few years for smaller businesses and individuals. The specific segment is the replicating rapid prototype RepRap (replicating rapid prototype), the extended version of which is the Prusa i3 printer.
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Добролюбова, Марина Валеріївна, Анна Василівна Шнира, Богдан Володимирович Чапалюк, and Андрій Іванович Алімов. "Monitoring and control system for RepRap 3D-printer with FDM printing technology." Information systems, mechanics and control, no. 14 (April 25, 2016): 5–15. http://dx.doi.org/10.20535/2219-380414201672548.
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Burde, Alexandru Victor, Cristina Gasparik, Sorana Baciu, Marius Manole, Diana Dudea, and Radu Septimiu Câmpian. "Three-Dimensional Accuracy Evaluation of Two Additive Manufacturing Processes in the Production of Dental Models." Key Engineering Materials 752 (August 2017): 119–25. http://dx.doi.org/10.4028/www.scientific.net/kem.752.119.
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In the current orthodontic and prosthodontics practice, study models made of plaster are being used to provide a three-dimensional view of the patient’s occlusion and allow the clinician to analyze, diagnose, or monitor anomalies. With the introduction of intraoral and extra oral digital impressions, it is now possible to obtain digital study models of the patients’ dental arches. Digital models can be obtained in a physical hardcopy via 3D printing or rapid prototyping. Although, professional 3D printers require a high initial set-up cost, low cost 3D printers can provide similar quality products. The aim of this study is to investigate the accuracy of physical dental models reconstructed from digital data by two rapid prototyping techniques. For this purpose twenty mandibular and maxillary conventional plaster models from randomly chosen subjects were selected and served as the gold standard. The casts were digitized using a 3D scanner and .stl surface models were acquired; the virtual model was adjusted for reconstruction using dedicated software, thus obtaining the CAD model of the casts. The CAD models were reconstructed using a 3D fused deposition modeling (FDM) printer, a RepRap FDM printer and an inverted stereolithography printer. The reconstructed models were digitized using a laboratory 3D scanner and the resulting Mesh datasets were compared with the CAD model using inspection software. The mean systematic differences for the 3D comparison of the reconstructed models were 0.207 mm for the stereolithography models, 0.156 mm for the FDM models, and 0.128 mm for the RepRap models. Although a technology proved the ability to manufacture a dental model with accentuated morphology, the results demonstrate that replicas of plaster casts are influenced by problems linked to the size of the detail to be reproduced, which is often similar to or finer than the fabrication layer.
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Šafka, Jiří, Michal Ackermann, Jiří Bobek, Martin Seidl, Jiří Habr, and Luboš Bĕhálek. "Use of Composite Materials for FDM 3D Print Technology." Materials Science Forum 862 (August 2016): 174–81. http://dx.doi.org/10.4028/www.scientific.net/msf.862.174.
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This article deals with specific polymer composites modified for the Fused Deposition Modelling (FDM) which is a 3D print technology. These two phase systems involve thermoplastic matrix filled with natural fibres. The crucial demand of this progressive technology is put on the accuracy of the semi-product formed into the filament shape. To reach the smooth production of 3D prototypes the filament should have a constant diameter. In the article, individual steps of the polymer composite pelletization and following pre-processing and processing activities are described. Among these steps the extrusion of the filaments belongs and subsequent print test on “RepRap” device accompanied by optimization of building parameters. Tensile specimens were chosen for print with regard to maps mechanical properties of this newly developed material which was the final stage of this work. Tensile test curves were then compared with those graphs which can be found for the material produced by conventional technologies such as injection moulding.
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Khan, Shaheryar Atta, Bilal Ahmed Siddiqui, Muhammad Fahad, and Maqsood Ahmed Khan. "Evaluation of the Effect of Infill Pattern on Mechanical Stregnth of Additively Manufactured Specimen." Materials Science Forum 887 (March 2017): 128–32. http://dx.doi.org/10.4028/www.scientific.net/msf.887.128.
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Additive manufacturing has stepped down from the world of Sci-Fi into reality. Since its conception in the 1980s the technology has come a long way. May variants of the technology are now available to the consumer. With the advent of custom built (open source) Fused Deposition Modeling based printing technology Fused Filament Fabrication (FFF), FDM/FFF has become the most used Additive Manufacturing technology. The effects of the different infill patterns of FDM/FFF on the mechanical properties of a specimen made from ABS are studied in this paper. It is shown that due to changes in internal structures, the tensile strength of the specimen changes. The study also investigate the effect of infill pattern on the build time of the specimen. Extensive testing yielded the optimal infill pattern for FDM/FFF. An open source Arduino based RepRap printer was used for the preparation of specimen and showed promising results for rapid prototyping of custom built parts to bear high loads. The study can help with the increase in the use of additive manufacturing for the manufacturing of mechanically functioning parts such as prosthetics
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Panda, Anton, Ema Nováková-Marcinčinová, Ľudmila Nováková-Marcinčinová, Tibor Krenický, and Tadeusz Zaborowski. "Production from PLA Materials Processed Vertically by FDM Method RP Technology." Key Engineering Materials 756 (September 2017): 80–87. http://dx.doi.org/10.4028/www.scientific.net/kem.756.80.
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The article is focused on the aspects in samples production of sophisticated material – PLA - PolyLacticAcid, PLA plastic. The main part of the work focuses on experimental production and testing of PLA material - PolyLacticAcid plastic, printed on RepRap 3D device that works on the "open source" principle. The article presents the outcomes of test materials in the form of measurement protocols recorded in the software, the measured values in a static tensile test, marked down in tables and shown in work graphs. The article describes selected and carried out tests of mechanical properties of PLA plastics extruded in different directions in this case carried out vertically by FDM rapid prototyping method of two PLA materials such as pure without additives blended with blue dye. The tests are mainly focused on the determination of ultimate tensile strength. Based on the results obtained, the samples made of two PLA materials were compared in the end to establish which produced PLA material sample is stronger. There are outputs in the form of logs, charts and tables that provide information about the executed tests and comparisons, which were made by the authors.
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Pan, Ai Qiong, Zi Fan Huang, Rui Jie Guo, and Jun Liu. "Effect of FDM Process on Adhesive Strength of Polylactic Acid(PLA) Filament." Key Engineering Materials 667 (October 2015): 181–86. http://dx.doi.org/10.4028/www.scientific.net/kem.667.181.
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Fused deposition modeling (FDM) is one of the most widely used technologies in rapid prototyping. On the principle of layered manufacturing, the melted polymer filament is extruded and formed. In order to achieve transition from nonfunctional prototypes to functional prototypes of FDMed models, using the RepRap Kossel delta 3D printer and 1.75mm diameter polylactic acid (PLA) filament, it was analyzed that the effects of the nozzle moving rate and slice thickness on adhesive strength based on the existing technology research by orthogonal test. The experiment results indicated that adhesive strength of filament increased both with the nozzle moving rate and with its slice thickness. The latter induced increase more significantly. Finally, comprehensive experiments had been performed to quantitatively study the adhesive strength variation with the filling rate, which provides data reference for setting proper filling rate. Reasonable filling rate setting can not only satisfy the strength requirement without debasement of printing quality, but also reduce filament consumption, improve the manufacturing efficiency and provide important instruction significance for actual printing.
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L. Melgoza, Evila, Guillem Vallicrosa, Lidia Serenó, Joaquim Ciurana, and Ciro A. Rodríguez. "Rapid tooling using 3D printing system for manufacturing of customized tracheal stent." Rapid Prototyping Journal 20, no. 1 (January 14, 2014): 2–12. http://dx.doi.org/10.1108/rpj-01-2012-0003.
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Purpose – This work aims to present the design of a new continuous tool-path strategy for open-source low-cost fused deposition modeling (FDM) machines, such as Fab@Home or RepRap; and the development of an innovative integrated tool to design and fabricate customized tracheal stents with any FDM machine and six patient parameters. Both contributions were validated and implemented by obtaining a customized medical-grade silicone tracheal stent. Design/methodology/approach – For the design of the new deposition strategy, a Python programming language was used. The new tool-path strategy was proposed as a continuous path to avoid drops and gaps and to improve the accuracy of the final model. Meanwhile, patient parameters were obtained by medical doctors and introduced into the innovative integrated system. On the one hand, one mold generated automatically, and viewed with Matlab® software, was fabricated with a Fab@Home machine, optimized with the continuous tool-path strategy. On the other hand, the same generated mold was viewed in SolidWorks/Excel software and was fabricated using a commercial FDM machine. Finally, the mold was filled with medical grade silicone, and a silicone tracheal stent was obtained. Findings – Path planning for extrusion technologies is still a major concern, especially for open-source FDM machines. The results obtained in this work show the benefits of applying the newly developed continuous tool-path strategy to optimize the performance and efficiency of these machines. In addition, the proposed innovative integrated system allows the fabrication of customized tracheal stents rapidly and affordably. Practical implications – The possibility of obtaining customized tracheal stents is a worthy challenge. Medical doctors could play a more active role and interact during the design process, helping to obtain more suitable stents. The method proposed herein would provide the opportunity to obtain real values from the trachea of a patient in the operating room and quickly fabricate a customized stent that would fit the patient's trachea perfectly. Originality/value – The results obtained in this work are relevant and have future applications in both the medical and the additive manufacturing fields. The optimized tool-path strategy can help to improve and enhance the use of low-cost FDM machines. Moreover, the innovative automatic design approach to fabricate tracheal stents may open new market opportunities in the medical device field.
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Sukindar, Nor Aiman, Mohd Khairol Anuar Mohd Ariffin, B. T. Hang Tuah bin Baharudin, Che Nor Aiza Jaafar, and Mohd Idris Shah Ismail. "Comparison on Dimensional Accuracy Using a Newly Developed Nozzle for Open-Source 3D Printer." Applied Mechanics and Materials 859 (December 2016): 15–19. http://dx.doi.org/10.4028/www.scientific.net/amm.859.15.
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Fused Deposition Modeling (FDM) or also known as RepRap (Replicating Rapid Prototyper) is a technology that is synonym with 3D printing. This technology has entered a new era with an increasing demand among the community. It has grown commercially in the market of open-source system and it is relatively low cost. Many efforts have been put towards the development of the system in both hardware and software to increase the quality and the performance. The research highlights the development of a new nozzle to evaluate the performance on dimensional accuracy in comparison to the original nozzle. The nozzle emphasizes the die angle for the polylactic acid (PLA) material, the liquefier design which provide constant heat in the liquefier chamber, as well as insulator for the liquefier using highly insulated material. The dimensional accuracies of both nozzles were compared where the result showed that the new nozzle provided better accuracy and stability on the extruding PLA material.
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Firshein, Janet. "Repeal of FDA experimental-drug rule sought." Lancet 347, no. 9012 (May 1996): 1396. http://dx.doi.org/10.1016/s0140-6736(96)91025-9.
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Furlow, Bryant. "Repeat proposal from the FDA for graphic tobacco warnings." Lancet Respiratory Medicine 7, no. 11 (November 2019): 936. http://dx.doi.org/10.1016/s2213-2600(19)30309-1.
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Retamal Cisterna, Silvia Natalia. "Principios educativos locales con miras a la autonomía: construcción de un nuevo discurso educativo en el territorio williche (Sur de Chile)." Foro de Educación 18, no. 1 (January 4, 2020): 24–45. http://dx.doi.org/10.14516/fde.650.
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Se presentan los resultados de una investigación centrada en generar una propuesta curricular autónoma con y para las escuelas de la comuna de San Juan de la Costa, territorio williche al sur de Chile. Las reflexiones concebidas en este documento refieren a procesos clave para repensar los fundamentos locales y un nuevo discurso educativo. Se conceptualizaron cuatro principios locales a partir de metodologías participativas considerando las singularidades del territorio, estos son: a) reconocer y reparar como base para la autonomía; b) conciencia colectiva para impugnar la fragmentación; c) desafiar la interculturalidad oficial: cambios de procedimientos y emancipación curricular y; d) abdicar del discurso del poder. En efecto, estos principios conformarían el punto de partida para elaborar las bases locales de una educación propia, en tanto se prevé en ello el inicio de cambios que van en la línea de reivindicaciones y reconocimiento de derechos de los pueblos indígenas.
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Menon, Sree Devi, Zalina Osman, Kho Chenchill, and William Chia. "A positive feedback loop between Dumbfounded and Rolling pebbles leads to myotube enlargement in Drosophila." Journal of Cell Biology 169, no. 6 (June 13, 2005): 909–20. http://dx.doi.org/10.1083/jcb.200501126.
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In Drosophila, myoblasts are subdivided into founders and fusion-competent myoblasts (fcm) with myotubes forming through fusion of one founder and several fcm. Duf and rolling pebbles 7 (Rols7; also known as antisocial) are expressed in founders, whereas sticks and stones (SNS) is present in fcm. Duf attracts fcm toward founders and also causes translocation of Rols7 from the cytoplasm to the fusion site. We show that Duf is a type 1 transmembrane protein that induces Rols7 translocation specifically when present intact and engaged in homophilic or Duf–SNS adhesion. Although its membrane-anchored extracellular domain functions as an attractant and is sufficient for the initial round of fusion, subsequent fusions require replenishment of Duf through cotranslocation with Rols7 tetratricopeptide repeat/coiled-coil domain-containing vesicles to the founder/myotube surface, causing both Duf and Rols7 to be at fusion sites between founders/myotubes and fcm. This implicates the Duf–Rols7 positive feedback loop to the occurrence of fusion at specific sites along the membrane and provides a mechanism by which the rate of fusion is controlled.
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Moloney, Patrick, Ruth Boylan, Marwa Elamin, Sean O’Riordan, Ronan Killeen, and Christopher McGuigan. "Semi-quantitative analysis of cerebral FDG-PET reveals striatal hypermetabolism and normal cortical metabolism in a case of VGKCC limbic encephalitis." Neuroradiology Journal 30, no. 2 (February 27, 2017): 160–63. http://dx.doi.org/10.1177/1971400916689578.
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In the context of delayed autoimmune encephalitis antibody results, functional imaging can support the diagnosis of limbic encephalitis associated with anti-voltage-gated potassium channel complex (VGKCC) antibodies. Here we present a typical case of VGKCC encephalitis in a 69-year-old woman whose symptoms responded to plasmapheresis. A cerebral 18F-fluoro-2-deoxy-d-glucose positron emission tomography (FDG-PET) scan performed prior to commencing treatment revealed striatal hypermetabolism assessed qualitatively and semi-quantitatively, with normal uptake in the cortex and cerebellum when analysed semi-quantitatively. Repeat FDG-PET imaging performed three months later revealed normalisation of striatal hypermetabolism. Previous case reports have described striatal hypermetabolism and/or cortical hypometabolism in patients with VGKCC encephalitis. However, most of these descriptions were based on qualitative analyses only and may represent the relative change in cortical metabolism compared with striatal metabolism. We recommend semi-quantitative analysis of cerebral FDG-PET, in addition to reporting the qualitative FDG-PET images.
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Moskowitz, Craig H., Heiko Schöder, Julie Teruya-Feldstein, Camelia Sima, Alexia Iasonos, Carol S. Portlock, David Straus, et al. "Risk-Adapted Dose-Dense Immunochemotherapy Determined by Interim FDG-PET in Advanced-Stage Diffuse Large B-Cell Lymphoma." Journal of Clinical Oncology 28, no. 11 (April 10, 2010): 1896–903. http://dx.doi.org/10.1200/jco.2009.26.5942.
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Purpose In studies of diffuse large B-cell lymphoma, positron emission tomography with [18F]fluorodeoxyglucose (FDG-PET) performed after two to four cycles of chemotherapy has demonstrated prognostic significance. However, some patients treated with immunochemotherapy experience a favorable long-term outcome despite a positive interim FDG-PET scan. To clarify the significance of interim FDG-PET scans, we prospectively studied interim FDG-positive disease within a risk-adapted sequential immunochemotherapy program. Patients and Methods From March 2002 to November 2006, 98 patients at Memorial Sloan-Kettering Cancer Center received induction therapy with four cycles of accelerated R-CHOP (rituximab + cyclophosphamide, doxorubicin, vincristine, and prednisone) followed by an interim FDG-PET scan. If the FDG-PET scan was negative, patients received three cycles of ICE (ifosfamide, carboplatin, and etoposide) consolidation therapy. If residual FDG-positive disease was seen, patients underwent biopsy; if the biopsy was negative, they also received three cycles of ICE. Patients with a positive biopsy received ICE followed by autologous stem-cell transplantation. Results At a median follow-up of 44 months, overall and progression-free survival were 90% and 79%, respectively. Ninety-seven patients underwent interim FDG-PET scans; 59 had a negative scan, 51 of whom are progression free. Thirty-eight patients with FDG-PET–positive disease underwent repeat biopsy; 33 were negative, and 26 remain progression free after ICE consolidation therapy. Progression-free survival of interim FDG-PET–positive/biopsy-negative patients was identical to that in patients with a negative interim FDG-PET scan (P = .27). Conclusion Interim or post-treatment FDG-PET evaluation did not predict outcome with this dose-dense, sequential immunochemotherapy program. Outside of a clinical trial, we recommend biopsy confirmation of an abnormal interim FDG-PET scan before changing therapy.
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Bhatt, Aashish D., Xiao-Feng Li, Geetika Bhatt, Goetz H. Kloecker, Vivek R. Sharma, and Ali Cahid Civelek. "Spatial and temporal variability of intratumoral 18F-FDG distribution in patients with cancer." Journal of Clinical Oncology 30, no. 15_suppl (May 20, 2012): e21149-e21149. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.e21149.
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e21149 Background: We previously reported that in mice models, tumor microenvironment is complex and intratumoral 18F-FDG distribution is heterogeneous. There were apparent spatial and temporal intratumoral 18F-FDG distribution changes occurring even within 24-48 hour interval in human cancer cell xenografts grown in nude mice. We hypothesized that what was documented in mice models may also be applicable to human patients with cancer. The objective of this study was to investigate the intratumoral spatial and temporal distribution of 18F-FDG in cancer patients. Methods: Five patients who had repeat PET/CT scans within 1-28 days and with no interval therapy were identified. All patients had fasted overnight and had blood glucose level of less than 200 mg/dl. They were injected with 8.0-14.0mCi of 18F-FDG intravenously, and whole body PET/CT scans were performed 60-80 minutes later utilizing a Siemens PET/CT scanner. Each patient’s intratumoral FDG activity distributions were mapped and compared to each other utilizing magnified digital images of the tumors. Results: Intratumoral FDG activity is very heterogeneous. Within the same tumor, there is a wide range of high and low FDG uptake variations. Apparent change in intratumoral FDG distribution was found within as short as a 24 hour interval in the same patient. Although the global tumoral FDG activity and liver FDG activity measured as SUVmaximum and SUVaverage were not significantly different from one PET/CT to another, there were significant spatial changes and variations of the tumor FDG activity between the two PET/CT images. Conclusions: Intratumoral 18F-FDG uptake is very heterogeneous and manifests both temporal and spatial changes within as short as 24 hours even in untreated cancer patients. This should be taken into consideration during FDG PET based therapy decisions, for example in tumor and nodal staging or radiation therapy planning.
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Monteiro, Larissa Ariene Lacerda, Yasmin Podlasinski da Silva, and Magda Patrícia Furlanetto. "Eficácia da terapia de fotobiomodulação em episiotomias." Fisioterapia Brasil 22, no. 1 (March 19, 2021): 86–101. http://dx.doi.org/10.33233/fb.v22i1.4481.
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Introdução: Com a finalidade de evitar e reduzir lesões dos tecidos do canal do parto, a episiotomia pode ser realizada. Contudo, complicações cicatriciais podem ocorrer e resultar em desconfortos e dificuldades nas atividades diárias das parturientes. O uso de fotobiomodulação (FBM) em episiotomia é considerada uma alternativa de método não farmacológico para auxiliar no tratamento e cuidado destas puérperas. Objetivo: Revisar os estudos publicados nos últimos 20 anos sobre o efeito da FBM em episiotomia. Métodos: Revisão sistemática da literatura realizada através de busca digital em artigos publicados em revistas eletrônicas, ensaios clínicos e ensaios clínicos randomizados, entre os anos de 2000 e 2020, nas bases de dados eletrônicas PEDro, PubMed, Science Direct e Bireme. Resultados: Foram verificados estudos com aplicação da FBM para reparo tecidual e analgesia em episiotomia. A partir da análise de estudos metodologicamente mais robustos, a FBM não pareceu apresentar benefícios na aceleração do processo cicatricial, mas alguns resultados positivos para o controle da dor. Conclusão: De acordo com os achados, são necessários mais estudos com adequação de parâmetros e qualidade metodológica para elucidar quais os efeitos do uso da FBM no tratamento de episiotomia.
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Ulaner, Gary A., Joshua Lilienstein, Mithat Gönen, Jocelyn Maragulia, Craig H. Moskowitz, and Andrew D. Zelenetz. "False-Positive [18F]Fluorodeoxyglucose-Avid Lymph Nodes on Positron Emission Tomography–Computed Tomography After Allogeneic but Not Autologous Stem-Cell Transplantation in Patients With Lymphoma." Journal of Clinical Oncology 32, no. 1 (January 1, 2014): 51–56. http://dx.doi.org/10.1200/jco.2013.50.8044.
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Purpose Determine the clinical significance of [18F]fluorodeoxyglucose (FDG)–avid lesions in patients with lymphoma treated with stem-cell transplantation. Methods All patients who underwent stem-cell transplantation for lymphoma at Memorial Sloan-Kettering Cancer Center between January 2005 and December 2009 and had post-transplantation FDG positron emission tomography/computed tomography (PET/CT) examinations were included. PET/CT examinations were evaluated for FDG-avid lesions suggestive of disease. Clinical records, biopsy results, and subsequent imaging examinations were evaluated for malignancy. Results Two hundred fifty-one patients were identified, 107 with allogeneic and 144 with autologous stem-cell transplantation. Of allogeneic stem-cell transplantation recipients, 50 had FDG-avid lesions suggestive of lymphoma, defined as FDG-avidity greater than liver background. However, only 29 of these 50 demonstrated lymphoma on biopsy, whereas biopsy attempts were benign in the other 21 patients. Sensitivity analysis determined that a 1.5-cm short axis nodal measurement distinguished patients with malignant from nonmalignant biopsies. In 21 of 22 patients with FDG-avid lymph nodes ≤ 1.5 cm, biopsy attempts were benign. In the absence of treatment, these nodes either resolved or were stable on repeat imaging. Disease-free survival of patients with FDG-avid ≤ 1.5 cm lymph nodes was comparable with patients without FDG-avid lesions. In comparison, autologous stem-cell transplantation patients rarely demonstrated FDG-avid lesions suggestive of disease without malignant pathology. Conclusion Twenty percent (21 of 107) of patients with an allogeneic stem-cell transplantation demonstrated FDG-avid lymph nodes up to 1.5 cm in short axis on PET/CT, which did not represent active lymphoma. After allogeneic stem-cell transplantation of patients with lymphoma, benign FDG-avid ≤ 1.5 cm lymph nodes can mimic malignancy.
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Garag, Seeta Sunil, and Sanjana Kumar. "A comparative study between ferrous carboxy maltose and iron sucrose in the management of post-partum anaemia in tertiary care hospital." International Journal of Reproduction, Contraception, Obstetrics and Gynecology 8, no. 12 (November 26, 2019): 4866. http://dx.doi.org/10.18203/2320-1770.ijrcog20195336.
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Background: Anaemia is a global public health problem contributing tremendously to maternal morbidity and mortality. It is the most common indirect cause of maternal mortality. Variety of injectable iron preparations are now available which can be effective tools for combating post-partum anaemia. This study aims to compare FCM (Ferrous carboxy maltose) and iron sucrose in the treatment of iron deficiency anaemia in post-partum women at KIMS, Hubli, Karnataka, India.Methods: This study was conducted at KIMS, Hubli in the year 2018-19 wherein 100 post-partum women with hb levels ranging from 5-10g% were selected for the study and randomly allocated into 2 groups- FCM group and iron sucrose group. They were administered 1g of FCM and 1g of iron sucrose respectively after clinical evaluation and baseline measurement of hb. They were followed up after 2 weeks for repeat hb% and review of signs and symptoms. FCM and iron sucrose were compared in terms of their efficacy.Results: The mean increase in hb% was found to be 3.2 g% in the FCM group and 2 g% in the iron sucrose group. FCM was also found to be more efficacious in providing relief of common signs and symptoms like easy fatigability and pallor compared to iron sucrose.Conclusions: Ferrous carboxy maltose was found to be more efficacious compared to iron sucrose.
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Rajasooriyar, Chrishanthi, Ming-Yin Lin, Rashi Kalra, Andrew Lim, and Kailash Narayan. "The role of positron emission tomography in the selection of patients for salvage hysterectomy following chemoradiotherapy for locally advanced cervical cancer." International Journal of Gynecologic Cancer 29, no. 2 (January 10, 2019): 266–71. http://dx.doi.org/10.1136/ijgc-2018-000088.
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BackgroundPatients selection for salvage hysterectomy following chemoradiotherapy of cervical cancer is vital to avoid significant morbidity. The purpose of this study was to describe the role of post-treatment F18-fluoro-2-deoxy-D-glucose positron emission tomography/computed tomography scanning (FDG-PET/CT) in patient selection for salvage hysterectomy.MethodsThis was a retrospective analysis of 49 patients with cervical cancer treated between January 1996 and December 2012 who were candidates for salvage hysterectomy.ResultsThree groups were defined based on institutional treatment guidelines, as experience in using post-treatment FDG-PET/CT to guide management evolved. Group 1 consisted of 15 patients who underwent planned hysterectomy based on clinical, cytological, or histological suspicion. Of these, only three (20%) patients had residual disease on histology. Group 2 consisted of 13 patients who had post-treatment FDG-PET/CT 3–6 months after the completion of chemoradiotherapy due either to suspicion of recurrence on examination or patients thought to be at high risk of recurrence at the primary site. Of these, eight patients had hysterectomy and four patients showed positive histology for residual tumor. Group 3 had 21 patients who showed isolated FDG uptake at the primary site on first FDG-PET/CT scanning at 6 months. A subsequent FDG-PET/CT scan after 3 months showed disease progression in seven and complete metabolic response in 14, and surgery was avoided in all patients.ConclusionFDG-PET/CT scanning at 6 months after radiotherapy is a good tool for assessing treatment response in patients with cervical cancer. In patients with persistent uptake on 6 months post-treatment FDG-PET/CT, repeat imaging at a 3-month interval helps in selecting patients for salvage hysterectomy.
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Lueck, John D., Ami Mankodi, Maurice S. Swanson, Charles A. Thornton, and Robert T. Dirksen. "Muscle Chloride Channel Dysfunction in Two Mouse Models of Myotonic Dystrophy." Journal of General Physiology 129, no. 1 (December 11, 2006): 79–94. http://dx.doi.org/10.1085/jgp.200609635.
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Muscle degeneration and myotonia are clinical hallmarks of myotonic dystrophy type 1 (DM1), a multisystemic disorder caused by a CTG repeat expansion in the 3′ untranslated region of the myotonic dystrophy protein kinase (DMPK) gene. Transgenic mice engineered to express mRNA with expanded (CUG)250 repeats (HSALR mice) exhibit prominent myotonia and altered splicing of muscle chloride channel gene (Clcn1) transcripts. We used whole-cell patch clamp recordings and nonstationary noise analysis to compare and biophysically characterize the magnitude, kinetics, voltage dependence, and single channel properties of the skeletal muscle chloride channel (ClC-1) in individual flexor digitorum brevis (FDB) muscle fibers isolated from 1–3-wk-old wild-type and HSALR mice. The results indicate that peak ClC-1 current density at −140 mV is reduced >70% (−48.5 ± 3.6 and −14.0 ± 1.6 pA/pF, respectively) and the kinetics of channel deactivation increased in FDB fibers obtained from 18–20- d-old HSALR mice. Nonstationary noise analysis revealed that the reduction in ClC-1 current density in HSALR FDB fibers results from a large reduction in ClC-1 channel density (170 ± 21 and 58 ± 11 channels/pF in control and HSALR fibers, respectively) and a modest decrease in maximal channel open probability(0.91 ± 0.01 and 0.75 ± 0.03, respectively). Qualitatively similar results were observed for ClC-1 channel activity in knockout mice for muscleblind-like 1 (Mbnl1ΔE3/ΔE3), a second murine model of DM1 that exhibits prominent myotonia and altered Clcn1 splicing (Kanadia et al., 2003). These results support a molecular mechanism for myotonia in DM1 in which a reduction in both the number of functional sarcolemmal ClC-1 and maximal channel open probability, as well as an acceleration in the kinetics of channel deactivation, results from CUG repeat–containing mRNA molecules sequestering Mbnl1 proteins required for proper CLCN1 pre-mRNA splicing and chloride channel function.
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Deivanayagam, Champion C. S., Rebecca L. Rich, Sita Danthuluri, Rick T. Owens, Joseph M. Patti, Magnus Höök, Lawrence J. DeLucas, and Sthanam V. L. Narayana. "Crystallization and preliminary X-ray analysis of B-domain fragments of a Staphylococcus aureus collagen-binding protein." Acta Crystallographica Section D Biological Crystallography 55, no. 2 (February 1, 1999): 525–27. http://dx.doi.org/10.1107/s0907444998010051.
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Recombinant proteins of monomeric and dimeric B-domain repeats of a Staphylococcus aureus FDA 574 collagen-binding adhesin have been crystallized. The single repeat unit (B1) was crystallized in a body-centered orthorhombic lattice with a = 96.9, b = 101.3, c = 120.8 Å in either the I222 or I212121 space group. These crystals diffracted to 2.5 Å resolution and the calculated Vm values of 3.2 and 2.2 Å3 Da−1 suggest the possibility of a dimer or a trimer in the asymmetric unit. The two-repeat fragment (B1B2) crystallized in the orthorhombic space group P212121 with cell dimensions a = 42.4, b = 79.4, c = 130.4 Å and diffracted to 2.3 Å resolution. For this species, the calculated Vm value of 2.2 Å3 Da−1 indicates the presence of a monomer in the asymmetric unit.
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Popova, Lucy, Lauren Kass Lempert, and Stanton A. Glantz. "Light and mild redux: heated tobacco products’ reduced exposure claims are likely to be misunderstood as reduced risk claims." Tobacco Control 27, Suppl 1 (September 12, 2018): s87—s95. http://dx.doi.org/10.1136/tobaccocontrol-2018-054324.
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IntroductionHeated tobacco products (HTPs) are being marketed in several countries around the world with claims that they are less harmful than combusted cigarettes, based on assertions that they expose users to lower levels of toxicants. In the USA, Philip Morris International (PMI) has submitted an application to the Food and Drug Administration (FDA) in 2016 seeking authorisation to market its HTPs, IQOS, with reduced risk and reduced exposure claims.MethodsWe examined the PMI’s Perception and Behavior Assessment Studies evaluating perceptions of reduced risk claims that were submitted to the FDA and made publicly available.ResultsQualitative and quantitative studies conducted by PMI demonstrate that adult consumers in the USA perceive reduced exposure claims as reduced risk claims.ConclusionThe data in the PMI modified risk tobacco product IQOS application do not support reduced risk claims and the reduced exposure claims are perceived as reduced risk claims, which is explicitly prohibited by the FDA. Allowing PMI to promote IQOS as reduced exposure would amount to a legally sanctioned repeat of the ‘light’ and ‘mild’ fraud which, for conventional cigarettes, is prohibited by the US law and the WHO Framework Convention on Tobacco Control.
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Jain, Amrita, and Sonia S. Asrani. "Study of safety and efficacy of injection ferric carboxymaltose in iron deficiency anemia in pregnancy." International Journal of Reproduction, Contraception, Obstetrics and Gynecology 10, no. 6 (May 27, 2021): 2298. http://dx.doi.org/10.18203/2320-1770.ijrcog20212165.
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Background: Iron deficiency is a common nutritional deficiency amongst women of childbearing age. Peri-partum iron deficiency anemia (IDA) is associated with significant maternal, fetal and infant morbidity. Ferric carboxymaltose (FCM) may be better tolerated than the conventional blood transfusions and oral iron supplements. The study was designed to assess the safety and efficacy of IDA correction with intravenous (I.V.) FCM in pregnant women with mild, moderate and severe anemia in their second and third trimesters and their post-partum period. Methods: Prospective observational study; Treatment effectiveness was assessed by repeat hemoglobin (Hb) measurements and patient report of well-being in the postpartum period. Safety was assessed by analysis of adverse drug reactions and fetal heart rate monitoring during the infusion.Results: Intravenous FCM infusion significantly increased Hb values above baseline levels in all women. Fetal heart rate monitoring did not indicate a drug related negative impact on the fetus. No serious adverse effects were found Conclusions: Our prospective data is consistent with existing observational reports of the safe and effective use of ferric carboxymaltose in the treatment of iron deficiency anemia in peri-partum period.
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Horvath, Lena, Andreas Seeber, Christian Uprimny, Dominik Wolf, David Nachbaur, and Florian Kocher. "Disseminated focal 18F-fluoro-deoxyglucose uptake upon granulocyte colony-stimulating factor therapy mimicking malignant bone infiltration: case report of a patient with very severe aplastic anemia." Therapeutic Advances in Hematology 11 (January 2020): 204062072097761. http://dx.doi.org/10.1177/2040620720977613.
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Combined 18F-fluoro-deoxyglucose ([18F]FDG) positron emission tomography and computed tomography ([18F]FDG-PET/CT) is increasingly used for the diagnostic and therapeutic management of hematologic and non-hematologic malignancies. Here, we describe a unique case of a patient presenting with very severe aplastic anemia and a mediastinal mass showing disseminated hypermetabolic lesions of the bones after receiving granulocyte colony-stimulating factor (G-CSF), highly suspicious for disseminated metastatic lesions. A 71-year-old patient presented with a 3 week history of dyspnea and fatigue. Blood tests showed severe pancytopenia and iliac crest bone marrow biopsy revealed an extensively hypoplastic bone marrow. Diagnostic work-up by histology, conventional cytogenetics and flow cytometry confirmed the diagnosis of very severe aplastic anemia. Besides blood transfusions, the patient was treated with G-CSF. Furthermore, computed tomography revealed a suspect mass in the anterior mediastinum, presenting with moderate glucose metabolism in the subsequent [18F]FDG-PET/CT scan. In addition, multiple disseminated and highly metabolic bone lesions of primarily the ribs were detected, suspicious of malignant bone infiltration. Since physiologic bone marrow activation by G-CSF-stimulation could not be ruled out, G-CSF therapy was interrupted to repeat the PET/CT scan 10 days later. On the second [18F]FDG-PET/CT the moderately hypermetabolic mediastinal mass persisted. However, the initially FDG-avid bone lesions almost completely resolved, rendering the diagnosis of G-CSF-induced bone marrow hypermetabolism very likely without the need for further invasive diagnostic procedures. The mediastinal mass was thereafter histologically verified as thymoma. Interpretation of [18F]FDG-PET/CT in patients with aplastic anemia may be complicated by the frequent therapeutic use of G-CSF. With G-CSF, islets of residual bone marrow activity can be visualized on [18F]FDG-PET/CT images that might be misinterpreted as malignant bone infiltration. Repeating PET/CT scan after G-CSF discontinuation can prevent unnecessary invasive diagnostic procedures in these patients.
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Kmietowicz, Zosia. "Repeal law that puts “FDA on the payroll of the industry,” says former NEJM editor." BMJ 334, no. 7591 (March 1, 2007): 447.2–447. http://dx.doi.org/10.1136/bmj.39140.456030.db.
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Zong, P., and M. Filip. "Real propagation event simulation of selective repeat data link layer protocol for VSAT FCM system." Electronics Letters 36, no. 17 (2000): 1492. http://dx.doi.org/10.1049/el:20001032.
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Casulo, Carla, Andrew D. Zelenetz, Craig H. Moskowitz, and Steven M. Horwitz. "Negative Interim FDG-PET Scan Is Predictive of Superior Outcome in T Cell Lymphoma." Blood 114, no. 22 (November 20, 2009): 1956. http://dx.doi.org/10.1182/blood.v114.22.1956.1956.
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Abstract Abstract 1956 Poster Board I-979 Background: Fluoro-deoxy-glucose positron emission tomography (FDG-PET) is a required staging study for diffuse large B-cell lymphoma and Hodgkin lymphoma. Numerous studies have demonstrated that FDG-PET performed after one to four cycles of multiagent chemotherapy (interim restaging) is predictive of outcome, with relapse rates much higher in patients with positive FDG-PET scans at interim restaging. The prognostic role of FDG-PET in T-cell lymphoma however is unclear and has yet to be well defined. Small retrospective studies have demonstrated FDG-PET avidity of T-cell lymphoma. Our experience confirms that the great majority of patients with mature T or NK lymphomas have FDG-PET avid disease. We hypothesized that the interim FDG-PET (int FDG-PET) may have prognostic importance in patients with T-cell lymphomas as they do in diffuse large B-cell lymphoma and Hodgkin lymphoma. Methods: We reviewed our T-cell lymphoma database to identify patients with mature T or NK lymphomas who had FDG-PET scans as part of complete staging at initial diagnosis as well as repeat PET imaging as part of restaging. Inclusion criteria required FDG-PET avid disease at baseline and treatment administered with curative intent. Results: We reviewed fifty four patients who met the above criteria. Histologies were as follows: peripheral T-cell lymphoma NOS (N=18), angioimmunoblastic T-cell lymphoma (N=5), anaplastic large cell lymphoma ALK-1- (N=15), anaplastic large cell lymphoma ALK-1+ (N=3), and other subtypes (N=13). Patients received a variety of initial chemotherapy regimens including CHOP (N=18), EPOCH (N=6), CHOP/ICE (N=20) or other treatments provided with curative intent. Twenty two patients were consolidated with high dose therapy and either autologous (N=18), or allogeneic (N=4) SCT. Fifty nine percent were PET negative at interim restaging (32/54), 7.4% were positive (4/54), 22 % were not available (12/54), and 11% had equivocal scans (6/54). Median follow up was 17 months. Median PFS for the entire group was 15 months. Median OS for the entire group was 40 months. The median OS of patients with negative int FDG-PET has not been reached, compared to the OS of patients with positive int FDG-PET of 10.2 months (p<.001). Patients with equivocal int FDG-PET had a median OS of 62 months, which was statistically superior to patients with positive int FDG-PET (p=.02). There was no significant difference in median OS in patients with negative versus equivocal int FDG-PET. Similar to what was observed in OS, the median PFS of patients with negative int FDG-PET has not yet been reached, compared to the PFS of patients with a positive int FDG-PET of 4.8 months (p=<.001). Patients with equivocal int FDG-PET had a statistically improved PFS of 16 months when compared to those with a positive int FDG-PET (p<.01). Patients with equivocal int FDG-PET had similar outcomes to patients with a negative int FDG-PET, and superior to those with a positive int FDG-PET, whose results were very poor. Conclusions: In this dataset, interim PET scans are strongly predictive of outcome. Patients with negative int FDG-PET enjoyed significantly longer remissions and better overall survival. Patients with negative int FDG-PET were more likely to receive consolidative therapy, which may contribute to their superior outcomes. This may be a potentially confounding factor. Nonetheless, achievement of a negative int FDG-PET appears to be a reliable predictor of outcome in patients with T-cell lymphomas and may have similar prognostic importance in these patients as they do in diffuse large B-cell lymphoma and Hodgkin lymphoma. It is reasonable to consider int FDG-PET in the restaging of patients with T-cell lymphomas. Disclosures: Zelenetz: Millenium Advisory board: Membership on an entity's Board of Directors or advisory committees. Horwitz:Allos Therapeutics, Inc: Consultancy, Research Funding.
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Amin, Omar, Douglas Cartwright, and Mohammed Azharuddin. "1 Hyperglycaemia in T1DM and pancreatitis related diabetes." Postgraduate Medical Journal 96, no. 1132 (January 22, 2020): 119.1–119. http://dx.doi.org/10.1136/postgradmedj-2020-fpm.1.
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IntroductionWith the introduction of blood ketone testing, it is now possible to quantify the level of ketosis prior to the patient developing life threatening diabetic keto-acidosis (DKA). Administering correction doses of short acting insulin based on ketone level, similar to that for diabetic sick day rules, may avoid critical care admissions, use of variable rate insulin infusions and reduce hospital admissions.Testing is not without its challenges in particular cost, risk of inappropriate testing in type 2 diabetics (T2DM) and misdiagnosis alternative causes of ketosis. We describe here the experience of introducing ketone testing to A+E and acute wards at a district general hospital.MethodsBlood ketone testing was introduced to A+E, 2 medical wards and 2 surgical wards together with training for ward staff and a written guideline. Ketone testing was triggered if a type 1 diabetic (T1DM) or pancreatitis related diabetic had a BM >14 mmol/L. Based on the ketone level the guideline prompted either no action, correction dose of short acting insulin followed by repeat testing or arterial blood gas analysis. A retrospective analysis was performed after 8 months to investigate compliance with the protocol and effect of the protocol on the incidence of inpatient DKA. Patients were identified through search of the laboratory information management system followed by a review of electronically scanned medical records.Results910 ketone tests were carried out representing 116 patients. 395 tests had no patient identifier and were therefore untraceable. Over half of patients (51%) had type 2 diabetes. Of the patients with T1DM/pancreatitis related diabetes 9 patients presented with DKA on admission. Nearly three quarters (73%) resolved with additional subcutaneous insulin as per protocol and 23% were started on a Variable Rate Insulin Infusion. 1 patient developed DKA during an inpatient admission and the protocol had not been followed in this case. The main reasons for deviation from the protocol was lack of documentation and repeat BM testing.ConclusionsThe protocol itself is very effective when used correctly. It clearly helps to identify patients at risk of deteriorating, and clearly outlines what steps should be taken. While the guideline is intended for patients with T1DM and Pancreatic Related Diabetes, there were many occasions where the ketone testing was used inappropriately on patients with T2DM. In response to this the protocol was updated to include additional guidance on management of hyperglycaemia in T2DM. Documentation and lack of patient identification information was another key issue.
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Moskowitz, Craig H., Stephen D. Nimer, Andrew D. Zelenetz, Paul A. Hamlin, Steven M. Horwitz, Ariela Noy, Carol S. Portlock, et al. "Normalization of FDG-PET Pre-ASCT with Additional Non-Cross Resistant Chemotherapy Improves EFS in Patients with Relapsed and Primary Refractory Hodgkin Lymphoma-Memorial Sloan Kettering Protocol 04-047." Blood 112, no. 11 (November 16, 2008): 775. http://dx.doi.org/10.1182/blood.v112.11.775.775.
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Abstract We have reported that outcome of transplant-eligible patients (pts) with relapsed and primary refractory HL is determined by three pre-second-line chemotherapy (ST) risk factors (RF): remission duration of <1 yr., extranodal disease and B symptoms. In addition, normalization of FDG-PET prior to ASCT is the most important factor predicting favorable EFS. We now report the preliminary results of an ongoing phase II risk-adapted study where HL pts receive the following: Favorable risk (0–1 RF) - one cycle of standard dose ifosfamide, carboplatin and etoposide (ICE) ST followed by one cycle of augmented ICE; unfavorable risk (2-RF)- 2 cycles of augmented ICE. All pts then underwent a restaging FDG-PET and the results determined the next treatment. Pts with a negative FDG-PET went directly to HDT/ASCT; however if the FDG-PET was still positive, pts received an additional four biweekly cycles of gemcitabine (1000 mg/m2), vinorelbine (20 mg/m2) and liposomal doxorubicin (15 mg/m2) (GVD) followed by repeat FDG-PET scan; pts without evidence of progression then received HDT/ASCT. Preceding high-dose chemotherapy and ASCT, patients that were radiation therapy-naive received involved field radiotherapy (IFRT) followed by total lymphoid irradiation. Selected previously irradiated patients received only IFRT. Sixty-two pts are evaluable; median follow-up of surviving pts is 30 months; median age was 35. Forty-eight pts had a remission duration of < 1 yr. of those, 28 had primary refractory disease; 28 had extranodal disease and 11 had B symptoms. All patients had previously failed doxorubicin-based chemotherapy; 18 had received prior radiation; of those, 13 failed in the radiation field. Following first ST chemotherapy with ICE, 3 pts progressed, while 37 pts normalized their FDG-PET scan and currently 31 of these pts are event-free. Twenty-five pts with an improving CT scan after ICE still had a persistently positive FDG-PET; they received the second ST with GVD. Of these, 13 pts normalized their FDG-PET scan and 11 are eventfree; the remaining 12 pts had persistently abnormal FDG-PET scan or progressed; only 4 of them are event-free. There was no difference in outcome between the pts who had normal FDG-PET after ICE (pre-ASCT) and those who achieved a negative FDG-PET scan because of the additional ST with GVD. Both of these cohorts had a statistically significant improvement in EFS compared to pts with a persistently positive FDG-PET. In total 46/62 (65%) pts on this program are currently event-free. One pt died from sepsis. Conclusion: For pts with relapsed and primary refractory HL our evolving strategy is to administer ST until normalization of FDG-PET is achieved prior to HDT/ASCT. Figure Figure
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Markou, Athina, Patrick Manning, Banu Kaya, Sam N. Datta, Jamshed B. Bomanji, and Gerard S. Conway. "[18F]fluoro-2-deoxy-d-glucose ([18F]FDG) positron emission tomography imaging of thymic carcinoid tumor presenting with recurrent Cushing’s syndrome." European Journal of Endocrinology 152, no. 4 (April 2005): 521–25. http://dx.doi.org/10.1530/eje.1.01839.
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We report a case of a young woman with Cushing’s syndrome (CS), in whom although endocrine investigations and negative pituitary imaging were suggestive of ectopic ACTH secretion, the results of inferior petrosal sinus (IPS) sampling after coricotropin-releasing hormone (CRH) stimulation were suggestive of pituitary ACTH hypersecretion. 111In-labelled octreotide and high-resolution computer tomography (CT) revealed a lesion possibly responsible for the ACTH source in the thymus. Thymectomy confirmed concomitant ectopic CRH and probable ACTH production by a thymic neuroendocrine carcinoma. After an 8-year remission period the patient developed a clinical and biochemical relapse. A high-resolution computed tomography (CT) scan of the thorax showed a 2-cm nodule in the thymic bed, which was positive on a [18F]fluoro-2-deoxy-d-glucose ([18F]FDG) positron emission tomography (PET) scan. However, a repeated thymectomy did not result in remission. A repeat [18F]FDG PET study showed persistent disease in the thymic bed and also uptake in the adrenals. The patient underwent bilateral adrenalectomy, which resulted in clinical remission. A further [18F]FDG PET scan 8 months later showed no progression of the thymic tumor and confirmed complete excision of the adrenals. This is a rare case of concomitant CRH and ACTH secretion from a thymic carcinoid tumor; the case illustrates the usefulness of functional imaging with [18F]FDG PET in the diagnosis, management and follow-up of neuroendocrine tumors.
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Malhotra, Gaurav, N. Nair, N. S. Baghel, and S. H. Moghe. "Clearance of Unusual Muscular Uptake of F-18 FDG in the Lower Lumbar Region on a Repeat FDG-PET Scan After Oral Chlorzoxazone Intervention." Clinical Nuclear Medicine 31, no. 7 (July 2006): 412–13. http://dx.doi.org/10.1097/01.rlu.0000223213.64074.2a.
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Quinn, K. A., H. Dashora, M. Ahlman, and P. Grayson. "OP0144 EFFECT OF TOCILIZUMAB ON VASCULAR INFLAMMATION BY 18F-FLUORODEOXYGLUCOSE POSITRON EMISSION TOMOGRAPHY: A PROSPECTIVE, LONGITUDINAL STUDY." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 92.1–92. http://dx.doi.org/10.1136/annrheumdis-2020-eular.2840.
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Background:Two randomized controlled trials have demonstrated clinical efficacy of tocilizumab for the treatment of giant cell arteritis (GCA)(1, 2). In these trials, clinical and laboratory measures were used to define the outcome measures. The direct effect of tocilizumab on vascular inflammation remains poorly characterized.Objectives:To prospectively evaluate vascular inflammation as measured by18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) in a longitudinal cohort of patients with GCA treated with tocilizumab over a several year follow-up period.Methods:Patients with GCA were recruited into a prospective, observational cohort. All patients fulfilled modified 1990 American College of Rheumatology (ACR) Classification Criteria for GCA. All patients underwent FDG-PET computed tomography (CT) prior to initiation of tocilizumab. A single reader reviewed all PET scans, blinded to clinical data. Qualitative assessment of FDG uptake relative to liver uptake by visual assessment (scale 0-3) was assessed in 9 arterial territories. A summary score, PET Vascular Activity Score (PETVAS), was calculated (scale 0-27).Patients underwent imaging at 6-12 month intervals per a standardized imaging protocol. In a subset of patients in whom tocilizumab was discontinued due to established remission, a repeat FDG-PET scan was obtained within 6 months of drug discontinuation.Change in PET activity over time was measured by linear regression. PET activity during established remission was compared to PET activity after discontinuation of tocilizumab. For some patients, tocilizumab was added to the existing treatment regimen without a substantive change in concomitant glucocorticoid dose. In a secondary analysis, patients were stratified by prednisone dosing (high dose prednisone >10mg/day prednisone, low dose prednisone ≤10mg/day prednisone during the imaging interval) to determine if tocilizumab had an effect on vascular inflammation independent of glucocorticoids.Results:22 patients were included in the study. All patients had clinically active disease at baseline with median baseline PETVAS 24.5 (23-27). There was a significant reduction in PETVAS over 2 years follow up (p<0.01 for linear trend) (Figure). Of note, there was continued progressive improvement in PETVAS in both year 1 and year 2 of treatment. Eight patients received concomitant high dose glucocorticoids and 14 patients remained on low dose glucocorticoids with the addition of tocilizumab. In patients who only received low dose prednisone, significant reduction in PETVAS was still observed with addition of tocilizumab (PETVAS 25.5 to 19.5, p=0.04). In a subset of 5 patients who discontinued tocilizumab due to established remission [median PETVAS 19 (17.5-22) at time of remission], a repeat FDG-PET scan within 6 months after treatment discontinuation showed worsening PET activity in 4 out of 5 patients [median PETVAS 23 (20-23)]. Two of these patients subsequently experienced a clinical disease relapse.Conclusion:Tocilizumab was associated with improved vascular inflammation as assessed by FDG-PET. There was continued improvement of vascular inflammation at both year 1 and year 2 of treatment, and early evidence suggests a rebound of vascular inflammation when tocilizumab was discontinued. These data provide rationale for long-term tocilizumab therapy in patients with GCA and for consideration of FDG-PET as an outcome measure in future clinical trials.References:[1]Stone JH, et al. N Engl J Med 2017;377:317-28.[2]Villiger PM, et al. Lancet 2016;387:1921-7.Figure.XXXDisclosure of Interests:None declared
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Tobe, Edward H. "Functional imaging: A necessary prerequisite to neuropsychological assessment." International Journal of Diagnostic Imaging 1, no. 2 (April 30, 2014): 74. http://dx.doi.org/10.5430/ijdi.v1n2p74.
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After traumatic brain injury, neuropsychological testing may be insensitive in documenting functional brain injury. Imaging with single-photon emission computed tomography (SPECT) and 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) scanning may identify brain injury that is missed on neuropsychological testing. A 27-year-old man had loss of consciousness after hydrogen sulfide exposure and a fall; he had markedly impaired function (short-term memory, sequential thinking, attention, and initiative), but neuropsychological testing showed only mild to moderate impairments. A 37-year-old woman had a whiplash injury and head trauma after an automobile accident; she had apprehension, dysphoria, word finding problems, impaired memory and concentration, and slowed thinking; neuropsy- chological testing was normal. In the man, SPECT scan showed decreased activity in the striatum, amygdala, and hippocampus bilaterally (decreased more in the right than left hemisphere); an FDG-PET scan showed markedly decreased metabolism in the left thalamus, heterogeneous abnormal uptake in the basal ganglia, and abnormally decreased metabolism in both temporal and inferior parietal lobes. In the woman, FDG-PET scan showed several regions of abnormal metabolic activity not restricted to single vascular territories and decreased activity in the left frontal lobe, left thalamus, and left caudate nucleus. Repeat neuropsychiatric testing in both patients showed cognitive and motor impairments that seriously limited routine activities of daily living. In summary, after traumatic brain injury associated with neuropsychological symptoms, SPECT and FDG-PET scanning may be more sensitive than neuropsychological testing in detecting objective signs of brain injury.
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Muslimani, A., H. Farag, S. Francis, T. P. Spiro, H. A. Daw, A. A. Chaudhry, and V. C. Chan. "The utility of 18-F-fluorodeoxyglucose positron emission tomography in evaluation of bone marrow involvement by non-Hodgkin lymphoma (NHL)." Journal of Clinical Oncology 25, no. 18_suppl (June 20, 2007): 8077. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.8077.
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8077 Introduction: In NHL, the anatomic extent of the disease is an important factor influencing the overall survival. Clinically, NHLs are classified as indolent, aggressive, or highly aggressive. Bone marrow (BM) involvement is a sign of extensive disease, and iliac crest (IC) BM biopsy (BMB) is the established method for the detection of BM infiltration. However, IC BMB is associated with a high rate of false- negative result. We assess the ability of 18F-FDG PET scan to ascertain the presence of BM involvement in NHL. Methods: We retrospectively reviewed charts from January 2002 through November 2006 of histologically proven NHLs. 87 patients (pts) were eligible for our study (38 males, 49 females; age range 42–81 years). All pts were examined by whole-body 18F-FDG-PET scan for initial staging, and all had unilateral posterior IC BMB. BM involvement was established following the result of 1) unilateral posterior IC BMB, and 2) image-guided BMB following positive 18F-FDG-PET scan in selected patients. Results: Among the PET+ / IC BMB- group, 3 pts had a positive CT-scan guided BMB at the site of involvement detected by the 18F-FDG-PET scan (2 from the humerus,1 from the femur); the remaining 7 pts did not have a site-directed biopsy. Our data demonstrate an overall sensitivity of 0.76 for the PET scan detecting BM involvement in all pts and specificity of 0.88. We point out that the 0.88 specificity may be spuriously low, this is a result of the fact that of the 10 PET+ / IC BMB- pts 7 have not had directed biopsy to the site of involvement detected by the18F-FDG- PET-scan. Further analysis revealed no significant difference between the sensitivity (P = 0.21) and specificity (p = 0.99) between I- NHL and A/HA- NHL groups. Conclusion: 18F-FDG-PET scan shows potential to detect BM involvement in NHL. In particular, image-guided repeat BMB may be considered in pts with negative initial IC BMB, whose 18F-FDG-PET scan demonstrates BM involvement in a different site. No significant financial relationships to disclose. [Table: see text]
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Howaldt, S., I. Jacob, M. Sampson, and F. Akriche. "P685 Healthcare resource use associated with ferric maltol and IV iron treatment for iron deficiency anaemia in patients with inflammatory bowel disease." Journal of Crohn's and Colitis 14, Supplement_1 (January 2020): S558. http://dx.doi.org/10.1093/ecco-jcc/jjz203.813.
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Abstract Background Iron deficiency anaemia (IDA) is common in patients with inflammatory bowel disease (IBD). IDA imposes a substantial economic burden on healthcare payers resulting primarily from increased medical costs and increased rates of hospital admission. Most guidelines recommend oral iron as first-line treatment, with IV iron if oral supplementation is ineffective or poorly tolerated. Intolerance to ferrous (Fe2+) oral iron is common in patients with IBD. Ferric maltol (FM), a stable oral complex of ferric (Fe3+) iron and maltol, is designed to reduce exposure to elemental iron and thus limit gastrointestinal damage. This analysis compares the Healthcare resource use (HCRU) associated with oral FM and IV ferric carboxymaltose (FCM) treatment. Methods Patients with IBD and IDA (haemoglobin [Hb] ≥8.0 g/dl and ≤11.0 g/dl for women or ≥8.0 g/dl and ≤12.0 g/dl for men, and ferritin <30 ng/ml or ferritin <100 ng/ml with transferrin saturation <20%) were randomised to FM (30 mg b.i.d) or IV FCM (as per local SmPC) in an open-label, Phase 3b non-inferiority study. The primary endpoint was Hb responder rate (proportion of patients achieving a ≥2 g/dl increase or normalisation of Hb at week 12); the margin for non-inferiority was 20%. HCRU was assessed based on the total costs of iron therapy (including drug costs and administration), and the number of hospital/outpatient visits during the initial 12-week study period. Costs of IV FCM and FM were applied to a German setting. Results 250 patients were randomised: 125 to FM and 125 to IV FCM. The non-inferiority endpoint was met. Mean (standard deviation; SD) total treatment costs per patient in the FM and IV FCM arms were €302.27 (€80.68) and €489.37 (€147.19) respectively. Eighty-seven per cent of FM patients were still receiving treatment at week 12, and 45% and 36% of IV FCM patients required a repeat course of IV iron at weeks 4 and 12, respectively. The mean (SD) number of hospital/outpatient visits during the study period for patients receiving IV FCM was 2.30 (0.88) and the total dose of IV FCM received was 1621 mg (491 mg). Conclusion Total per patient drug costs were approximately 1.6 times higher for treatment with IV FCM than FM. The total cost of IV FCM is not only influenced by the higher drug cost, but additional costs associated with IV administration which was required to be carried out in a hospital or outpatient setting. FM has no additional costs or resource use associated with administration and is, therefore, less of a burden on local healthcare systems. FM is associated with non-inferior efficacy and substantially lower HCRU than IV FCM, and may provide a cost-effective oral alternative to IV iron in patients with IBD.
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Cartwright, Carmen, and Patamaporn Lekprasert. "Thyroid Lymphoma: A Rare Cause of Thyroid Malignancy." Journal of the Endocrine Society 5, Supplement_1 (May 1, 2021): A902—A903. http://dx.doi.org/10.1210/jendso/bvab048.1842.
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Abstract Background: Primary Thyroid Lymphoma is rare accounting for 2-5% of all thyroid malignancies and less than 2% of extranodal lymphomas. Data has suggested annual incidence to be 2 per 1 million. (1) Clinical Case: A 72-year-old female with coronary artery disease, hyperlipidemia and hypothyroidism was diagnosed with extranodal follicular cell lymphoma of the breast. FDG-PET showed evidence of diffuse avidity within her thyroid gland, with SUV of 13.8. She denied any drastic change in the size of her neck or any compressive symptoms. Thyroid ultrasound performed months before her diagnosis of lymphoma, showed a two-fold increase, most notable to the right lobe compared to prior imaging; her gland remained otherwise unchanged with heterogenous echotexture. Fine needle aspiration and flow cytometry were obtained on thyroid tissue that showed follicular cell lymphoma. She was started on single-therapy Rituxan regimen with oncology. Several months later appearance and examination of her neck had improved with decrease in size of thyroid gland. Repeat FDG-PET scans, with the most recent being 11 months after starting Rituxan therapy, showed reduction in the avidity within the thyroid gland and decreasing size; with SUV of 7.8. Repeat thyroid ultrasound continued to show heterogeneous echotexture with overall decrease in volume in gland size by nearly 50% within the right lobe and approximately 30% within the left lobe. Conclusion: Thyroid lymphoma should be suspected in a rapidly enlarging thyroid gland with or without pain or compressive symptoms. However, we propose that it should also be considered in the setting of FDG-PET avidity in thyroid tissue in setting of clinical suspicion. Diffuse FDG-PET scan avidity in the thyroid gland does not automatically equate to malignancy as prospective and retrospective information has shown that diffuse uptake can be seen incidentally, in cases of diffuse goiter, Graves disease or chronic lymphocytic thyroiditis and that the uptake has been seen to range between 5.6-16.8 SUV. (2) The American Thyroid Association 2015 thyroid cancer guidelines propose that if diffuse uptake is seen within the thyroid gland on PET imaging that thyroid ultrasound imaging and functional testing be undertaken. If imaging shows findings suggestive of only chronic lymphocytic thyroiditis (diffuse heterogeneous gland) that no further action is required. In this patient a different approach was taken with investigations pursued in the setting of enlarging thyroid gland on imaging and known extranodal lymphoma allowing for ultimate diagnosis. References: 1. Stein, S., et al. “Primary Thyroid Lymphoma: A Clinical Review.” The Journal of Clinical Endocrinology & Metabolism, vol. 98, no. 8, 2013, pp. 3131-3138 2. Karantanis, D., et al. “Clinical Significance of Diffusely Increased 18F-FDG Uptake in the Thyroid Gland.” Journal of Nuclear Medicine, vol. 48, no. 6, 2007, pp. 896-901
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B, Vijayakumary, Ramachandran C, Bharath V M, Madhu Muralee, and Jubie Raj. "Hot liver on 18F-FDG PET/CT imaging—a quandary for oncoradiologists in South Asia." BJR|case reports 6, no. 2 (June 2020): 20190097. http://dx.doi.org/10.1259/bjrcr.20190097.
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A 56-year-old female presented with intermittent hemoptysis and was diagnosed with lung cancer. 18F-fluorodeoxyglucose positron emission tomography/CT for staging revealed hypermetabolic liver (hot liver), uptake in the mediastinal lymph nodes and reduced uptake in the kidneys. Unexpectedly, liver biopsy findings were consistent with tuberculous infection. Following the intensive phase of antituberculous treatment, repeat CT revealed significant resolution of the mediastinal lymph nodes making the lung cancer Stage 1 (T1 lesion). She underwent left lower lobectomy as a definitive surgical treatment. Positron emissiontomography/CT scan in this patient was considered to be a hepatic superscan since it revealed a hot liver.
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Melani, Christopher Joseph, Ranjana Advani, Clara C. Chen, Kelsey M. Walters, David Venzon, Seth M. Steinberg, Margaret Shovlin, et al. "DA-EPOCH-R in Primary Mediastinal B-Cell Lymphoma; Analysis of End of Therapy FDG-PET and Outcome." Blood 128, no. 22 (December 2, 2016): 1116. http://dx.doi.org/10.1182/blood.v128.22.1116.1116.
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Abstract Background: Primary mediastinal B-cell lymphoma (PMBL) is a distinct diffuse large B-cell lymphoma that occurs in adolescents and young adults. Retrospective studies suggest dose-intensive therapy is more effective than R-CHOP, and support a role for mediastinal radiation following R-CHOP. We demonstrated that DA-EPOCH-R is effective and obviates the need for mediastinal radiation, thus eliminating the risk of long-term toxicities (NEJM 2013;368:1408-16). End of therapy (EOT) FDG-PET is often performed to assess residual mass activity. The clinical value of EOT negative FDG-PET is under investigation in an international study in which FDG-PET negative patients are randomized to receive radiation or observation following immunochemotherapy (IELSG 37). All patients with an EOT positive FDG-PET receive mediastinal radiation. Herein, we investigate the predictive value of EOT FDG-PET following DA-EPOCH-R and provide updated results from the National Cancer Institute (NCI) and Stanford University Hospital publication of PMBL (NEJM 2013;368:1408-16). Methods: Ninety-two patients with newly diagnosed PMBL were treated with DA-EPOCH-R (Table 1). DA-EPOCH-R was administered for 6-8 cycles as previously described and no patients received up-front radiation. EOT FDG-PET was performed in 76 (83%) patients and scored retrospectively according to Deauville criteria with scores 4 to 5 called positive and scores 1 to 3 called negative. Patients with EOT positive FDG-PET scans were followed with serial scans to distinguish persistent disease from resolving inflammatory changes. The NCI and Stanford cohorts showed no significant differences in outcome and were therefore combined for analysis of event free survival (EFS) and overall survival (OS). Analyses of EFS and OS in patients with Deauville positive and negative EOT FDG-PET scans were also performed. Results: Patient characteristics were similar in the NCI and Stanford cohorts (Table 1). Overall, the median age was 31 years (range, 18 to 68), 59% were female, 59% had mediastinal masses > or = 10 cm and 20% of patients had stage IV disease. At a median follow-up of 5.3 years, the EFS and OS are 90% and 94%, respectively (Figure 1). Of 76 EOT FDG-PET scans performed, 25 (33%) were positive (Deauville score 4 or 5) and 51 (67%) were negative (Deauville score 1 to 3). Only 1 (2%) patient with an EOT negative FDG-PET scan relapsed (at 1 year), and 5 (20%) patients with an EOT positive FDG-PET scan had residual disease and received further therapy. EOT FDG-PET had a sensitivity and specificity of 83% and 71%, respectively, and a positive and negative predictive value of 20% and 98%. Comparison of outcome for EOT FDG-PET negative and positive patients at 5.3 years was 92% and 80% for EFS (p= 0.043), respectively, and was 94% and 91% for OS (p= 0.37) (Figure 2). Serial monitoring of false positive EOT FDG-PET scans showed reduction or occasionally stabilization of SUV, which is consistent with inflammatory causation. There were no events in the 16 patients without evaluable EOT FDG-PET scans resulting in an EFS of 100%. This EFS, however, was not significantly different than that of patients with evaluable EOT FDG-PET scans. Conclusions: DA-EPOCH-R (without radiation) is highly effective in PMBL and has an EFS of 90% with long-term follow-up. An EOT negative FDG-PET has a negative predictive value of 98%. Even among patients with an EOT positive FDG-PET, 80% are cured of disease and achieve long-term remission. These results demonstrate that EOT Deauville 4-5 FDG-PET scans following DA-EPOCH-R do not accurately identify patients with residual disease in most cases and should not be used to justify mediastinal radiation. In the absence of disease progression on CT scans, patients with EOT positive FDG-PET scans should be carefully monitored with short interval (e.g. 4-6 weeks) repeat FDG-PET scans to assess progressive SUV changes and need for biopsy before instituting further therapy. Table 1 Patient Characteristics Table 1. Patient Characteristics Figure 1 Kaplan-Meier Estimate of EFS for Combined NCI and Stanford Cohorts Figure 1. Kaplan-Meier Estimate of EFS for Combined NCI and Stanford Cohorts Figure 2 Kaplan-Meier Estimate of EFS by EOT FDG-PET Deauville Score Figure 2. Kaplan-Meier Estimate of EFS by EOT FDG-PET Deauville Score Disclosures Advani: Kyowa Hakko Kirin: Consultancy, Honoraria; Infinity: Research Funding; FortySeven: Consultancy, Honoraria; Genentech: Consultancy, Honoraria, Research Funding; Sutro: Consultancy, Honoraria; Spectrum: Consultancy, Honoraria; BMS: Consultancy, Honoraria, Research Funding; Juno: Consultancy, Honoraria; Stanford University: Employment; Millennium: Research Funding; Kura: Research Funding; Celgene: Research Funding; Regeneron: Research Funding; Merck: Research Funding; Pharmacyclics: Research Funding; Janssen: Research Funding; Seattle Genetics: Research Funding; Agensys: Research Funding.
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Adeli, Anahita, Rodolfo Savica, Val J. Lowe, Prashanthi Vemuri, David S. Knopman, Mariely DeJesus-Hernandez, Rosa Rademakers, et al. "The GGGGCC Repeat Expansion inC9ORF72in a Case with Discordant Clinical and FDG-PET Findings: PET Trumps Syndrome." Neurocase 20, no. 1 (November 30, 2012): 110–20. http://dx.doi.org/10.1080/13554794.2012.732090.
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Dolskiy, Alexander A., Vladimir O. Pustylnyak, Andrey A. Yarushkin, Natalya A. Lemskaya, and Dmitry V. Yudkin. "Inhibitors of Histone Deacetylases Are Weak Activators of the FMR1 Gene in Fragile X Syndrome Cell Lines." BioMed Research International 2017 (2017): 1–5. http://dx.doi.org/10.1155/2017/3582601.
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Fragile X syndrome is the most common cause of inherited intellectual disability in humans. It is a result of CGG repeat expansion in the 5′ untranslated region (5′ UTR) of the FMR1 gene. This gene encodes the FMRP protein that is involved in neuronal development. Repeat expansion leads to heterochromatinization of the promoter, gene silencing, and the subsequent absence of FMRP. To date, there is no specific therapy for the syndrome. All treatments in clinic practice provide symptomatic therapy. The development of drug therapy for Fragile X syndrome treatment is connected with the search for inhibitors of enzymes that are responsible for heterochromatinization. Here, we report a weak transcriptional activity of the FMR1 gene and the absence of FMRP protein after Fragile X syndrome cell lines treatment with two FDA approved inhibitors of histone deacetylases, romidepsin and vorinostat. We demonstrate that romidepsin, an inhibitor of class I histone deacetylases, does not activate FMR1 expression in patient cell cultures, whereas vorinostat, an inhibitor of classes I and II histone deacetylases, activates a low level of FMR1 expression in some patient cell lines.
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Rana, Surinder Singh, Ujjwal Gorsi, Pankaj Gupta, Ravi Sharma, Rajender Basher, Lovneet Dhalaria, and Rajesh Gupta. "Pancreatic Cancer Masked by Acute Pancreatitis as well as an Unusual Iatrogenic Complication." Journal of Digestive Endoscopy 09, no. 02 (April 2018): 088–91. http://dx.doi.org/10.4103/jde.jde_95_17.
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ABSTRACT A 62‑year‑old female presented with abdominal pain and was diagnosed as acute on chronic pancreatitis based on elevated serum amylase and imaging findings. The pancreatic duct was dilated with abrupt cutoff at neck of pancreas, but no mass was visualized. Positron emission tomography‑computed tomography (PET‑CT) revealed a fluorodeoxyglucose (FDG) avid lesion in the neck of the pancreas but ultrasound (USG)‑guided fine‑needle aspiration (FNA) from the lesion revealed only inflammatory cells. Endoscopic ultrasound, done 2 days after USG‑guided FNA, revealed pseudoaneurysm (PA) in the neck of pancreas that was confirmed on CT angiography. The PA was occluded by USG‑guided percutaneous cyanoacrylate injection. As pain persisted, repeat PET CT was done which revealed FDG avidity around the cyanoacrylate cast as well in multiple small hypodense lesions in the right lobe of the liver. USG‑guided FNA from both the liver lesion as well as the periphery of the glue cast revealed features of adenocarcinoma. We herein report a case of pancreatic adenocarcinoma that presented as acute pancreatitis and got masked because of formation of PA consequent to USG‑guided FNA.
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Faizah, Rokhana, Sri Wening, Yurna Yenni, and Sujadi Sujadi. "GENETIC TRACEABILITY OF OIL PALM PROGENIES (Elaeis guineensis JACQ.) USING SIMPLE SEQUENCE REPEAT (SSR)." Jurnal Penelitian Kelapa Sawit 24, no. 3 (March 11, 2018): 103–14. http://dx.doi.org/10.22302/10.22302/iopri.jur.jpks.v24i3.14.
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Progenies traceability status becomes an important activity in the oil palm breeding program, especially to obtain propriety of individual and progenies population with their parents. This study is concerned to analyze genetic traceability based on pattern and allele size of their parent using Simple Sequence Repeat (SSR) markers. There were 90 palms from 7 progenies populations in the AD02S, AD03S Adolina and MA22S Marihat Estate PT. Perkebunan Nusantara IV used in this research. Leaf and pollen samples were used to get genomic DNA. Then, DNA genomic was amplified using multiplexing method of 8 SSR markers and fluorescence labels of 6-FAM, HEX, and NED. Fragment analysis and extracted genotype data was obtained using Gene Marker® versi 2.4.0 Soft Genetics® LLC program. Genetic traceability analysis was based on alelle segregation pattern of Mendelian Law. The results described inappropriate alleles 4 individuals from 3 progenies (N, P, and S). Those individuals were palmrow of 22-30 in the AD02S; 29-27 in the MA22S; 9-22 and 9-28 in the AD02S. Other 4 progenies showed an appropriate segregation of genotype with their parents, which are crosses number of M, Q, R, and O.
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Faizah, Rokhana, Sri Wening, Yurna Yenni, and Sujadi Sujadi. "GENETIC TRACEABILITY OF OIL PALM PROGENIES (Elaeis guineensis JACQ.) USING SIMPLE SEQUENCE REPEAT (SSR)." Jurnal Penelitian Kelapa Sawit 24, no. 3 (December 1, 2016): 103–14. http://dx.doi.org/10.22302/iopri.jur.jpks.v24i3.14.
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Progenies traceability status becomes an important activity in the oil palm breeding program, especially to obtain propriety of individual and progenies population with their parents. This study is concerned to analyze genetic traceability based on pattern and allele size of their parent using Simple Sequence Repeat (SSR) markers. There were 90 palms from 7 progenies populations in the AD02S, AD03S Adolina and MA22S Marihat Estate PT. Perkebunan Nusantara IV used in this research. Leaf and pollen samples were used to get genomic DNA. Then, DNA genomic was amplified using multiplexing method of 8 SSR markers and fluorescence labels of 6-FAM, HEX, and NED. Fragment analysis and extracted genotype data was obtained using Gene Marker® versi 2.4.0 Soft Genetics® LLC program. Genetic traceability analysis was based on alelle segregation pattern of Mendelian Law. The results described inappropriate alleles 4 individuals from 3 progenies (N, P, and S). Those individuals were palmrow of 22-30 in the AD02S; 29-27 in the MA22S; 9-22 and 9-28 in the AD02S. Other 4 progenies showed an appropriate segregation of genotype with their parents, which are crosses number of M, Q, R, and O.
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Eschmann, S. M., G. Friedel, F. Paulsen, M. Reimold, T. Hehr, W. Budach, H. Dittmann, H. J. Langen, and R. Bares. "Repeat 18F-FDG PET for monitoring neoadjuvant chemotherapy in patients with stage III non-small cell lung cancer." Lung Cancer 55, no. 2 (February 2007): 165–71. http://dx.doi.org/10.1016/j.lungcan.2006.09.028.
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Azhikannickal, Elizabeth, and Aaron Uhrin. "Dimensional Stability of 3D Printed Parts: Effects of Process Parameters." Ohio Journal of Science 119, no. 2 (July 12, 2019): 9. http://dx.doi.org/10.18061/ojs.v119i2.6593.
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The three-dimensional (3D) printing manufacturing process begins with the creation of a 3D model—using computer aided design (CAD) software—of the part to be printed. Using a type of 3D printing known as fused deposition modeling (FDM®), the 3D printer extrudes molten plastic to scan lines to create individual layers (i.e., the infill): one on top of the other. (Note that "scan" in this context refers to the movement of the extruder head, along an x,y coordinate path, while depositing molten plastic.) This process is repeated until the overall geometry, specified by the 3D model, is built. This process is attractive for producing proof of concept or prototype parts in various fields including automotive, aerospace, and medical. However, FDM subjects the material to rapid heating and cooling; therefore, some degree of undesirable warpage of the part occurs post fabrication. The primary objective of this study was to determine the effect of 4 process parameters (i.e., infill shape, infill density, number of perimeters created per layer, and layer height) on the total dimensional error of a representative 3D-printed part. This part (the "simple part"), used in Trials 1 through 3 of this study, was a square acrylonitrile butadiene styrene (ABS) plate having a nominal measurement of 50 mm × 50 mm × 5 mm thick. A residual error (the difference between the measured post-printing dimension and the theoretical CAD file dimension) was calculated along each given direction and for each test print. Finally, a root mean square (RMS) error (i.e., the square root of the average of the squared residual errors along the length, width, and thickness directions) was calculated for each printed part. Three repeat test prints were carried out for each parameter. The number of perimeters played a key role in the dimensional stability of the part. As the number of perimeters increased up to 5, the RMS error decreased. Beyond 5 perimeters, however, the RMS error increased due to excessive warpage/curvature at the corners of the part. Ultimately, when examined individually, a grid infill shape at 100% density, a 0.4 mm layer height, and 5 perimeters each produced the lowest warpage. In combination, these same 4 parameters also produced the lowest RMS error (based on dimensional analysis of 3 test prints) when used to print a more complicated part (the "stacked part") in Trial 4.
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Rao, V. Koneti, Susan Price, Lori Dodd, Remaley Alan, Millie Whatley, Jorge Carrasquillo, and Clara C. Chen. "Utility of Fluorodeoxyglucose Positron Emission Tomography(FDG-PET) and Biomarkers, Serum Vitamin B12 and HDL for Assessing Lymphoproliferation in Children and Adults with Autoimmune Lymphoproliferative Syndrome Due to FAS Mutations (ALPS-FAS)." Blood 128, no. 22 (December 2, 2016): 4891. http://dx.doi.org/10.1182/blood.v128.22.4891.4891.
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Abstract Introduction/Background: The autoimmune lymphoproliferative syndrome (ALPS) is a disorder of impaired lymphocyte apoptosis commonly associated with defects in the FAS gene in the CD95 signaling cascade. Childhood onset lymphadenopathy, splenomegaly and autoimmune cytopenias are characteristic clinical presentation of ALPS. The immunophenotypical hallmark of ALPS is the expansion of "double negative" TCR-__+T lymphocytes (DNTs) that lack both CD4 and CD8 markers and when these cells comprise more than 1.5% of all circulating lymphocytes. Patients with ALPS are at increased risk for B-cell lymphoma. Patients and Methods: We sought to evaluate the lymphoproliferative burden of patients referred to our institution and meeting the diagnostic criteria for ALPS using FDG-PET scans over a 10year period. Readily available biomarkers like serum vitamin B12 and HDL have also been very useful in diagnosis and follow up of patients with ALPS-FAS. Results: We have performed 91 FDG-PET scans in 76 ALPS patients. Whole body PET scans were performed, extending from the pelvis up to the cervical nodal regions, starting at 90 minutes after the FDG injection. The longer uptake times were chosen to account for nonmalignant nature of the condition under study. This included patients with ALPS-FAS (n=71) who had a median standardized uptake value (SUV) of 7.87 (range: 3.8-13.73) and non-FAS patients (n=20) with a median SUV of 7.47 (range: 4.21-14.41); none of these patients had lymphoma on clinical evaluation and further follow-up. In addition, 3 ALPS-FAS patients with lymphoma who underwent an FDG-PET scan prior to therapy for lymphoma had SUVs of 11.78, 15.24, and 26.86, respectively. Here we share the SUVMax data from PET imaging and associated biomarker data (serum vitamin B12, n=64 and serum HDL, n=21) available from 64 patients with ALPS-FAS (Table 1). FDG-PET SUVMax did not statistically correlate with high serum vitamin B12 levels and low serum HDL (n=21) (Correlation coefficient -0.14 and -0.02 respectively). Younger ALPS-FAS patients with more prolific lymphoproliferation were noted to have higher serum vitamin B12 values and more FDG avid lymphadenopathy in our series (Correlation coefficient Ð 0.56 and 0.29 respectively). Conclusions: 1. FDG accumulates in the lymph nodes of patients affected by ALPS, but we postulate that FDG may accumulate in higher concentrations in lymph nodes from ALPS patients that have undergone malignant transformation. 2. Clinical correlation including history of sudden onset focal enlargement of nodes and systemic symptoms is essential to suspect a diagnosis of lymphoma in ALPS-FAS patients as FDG-PET scans by themselves have limited utility in patients with background of nonmalignant lymphoproliferative disorders. 3. FDG-PET/CT may aid the early detection of lymphoma in this at-risk population, as ALPS patients have a predisposition to develop malignancies, and choosing the most FDG avid lymph nodes for biopsy may reduce the need for repeat biopsies in response to lymph node size changes commonly observed in ALPS patients. 4. For diagnosis as well as assessing lymphoproliferative burden during long term follow up of ALPS-FAS patients both high serum vitamin B12 levels and lipid profile (low serum HDL) can be used as surrogate biomarkers even though they do not correlate very well with FDG avidity of their lymph nodes (Figure1) in the limited series presented here*. *Reference: Moraitis AG, Freeman LA, Shamburek RD, Wesley R, Wilson W, Grant CM, Price S, Demosky S, Thacker SG, Zarzour A, Hornung RL, Pucino F, Csako G, Yarboro C, McInnes IB, Kuroiwa T, Boumpas D, Rao VK, Illei GG, Remaley AT. Elevated interleukin-10: a new cause of dyslipidemia leading to severe HDL deficiency.J Clin Lipidol. 2015 Jan-Feb;9(1):81-90. PMID: 25670364. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.
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Osterberg, Robert E., and Norman A. See. "Toxicity of Excipients—A Food and Drug Administration Perspective." International Journal of Toxicology 22, no. 5 (September 2003): 377–80. http://dx.doi.org/10.1177/109158180302200507.
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Excipients are essential components of drug products. They are also potential toxicants. Examples of known excipient-induced toxicities include renal failure and death from diethylene glycol, osmotic diarrhea caused byingested mannitol, hypersensitivity reactions from lanolin, and cardiotoxicity induced by propylene glycol. Proposals to test or market new drug products in the United States should adequately address the safety of the proposed exposure to the excipients in those products. The specific safety data that may be needed will vary depending upon the clinical situation, including such factors as the duration, level, and route of exposure, but may include acute, repeat-dose, reproductive, and genetic toxicity data, carcinogenicity data, and specialized toxicology information, such as sensitization or local irritation data. Many guidances exist to aid in the development of pharmaceuticals, including the International Conference on Harmonization (ICH) documents and various Food and Drug Administration/Center for Drug Evaluation and Research (FDA/CDER) pharmacology and toxicology guidances. The FDA/CDER has recently adopted a new guidance for industry, “Nonclinical Studies for Development of Pharmaceutical Excipients,” which focuses on issues associated with development of safety databases that will support clinical use of excipients in drug products. The new guidance document is introduced and discussed in this article.
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Lukey, Pauline T., Stephen A. Harrison, Shuying Yang, Yim Man, Beverley F. Holman, Alaleh Rashidnasab, Gabrielle Azzopardi, et al. "A randomised, placebo-controlled study of omipalisib (PI3K/mTOR) in idiopathic pulmonary fibrosis." European Respiratory Journal 53, no. 3 (February 14, 2019): 1801992. http://dx.doi.org/10.1183/13993003.01992-2018.
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Phosphatidylinositol 3-kinases (PI3Ks) and mammalian target of rapamycin (mTOR) play a role in the pathogenesis of idiopathic pulmonary fibrosis (IPF). Omipalisib (GSK2126458) is a potent inhibitor of PI3K/mTOR.A randomised, placebo-controlled, double-blind, repeat dose escalation, experimental medicine study of omipalisib in subjects with IPF was conducted (NCT01725139) to test safety, tolerability, pharmacokinetics and pharmacodynamics. Omipalisib was dosed at 0.25 mg, 1 mg and 2 mg twice daily for 8 days in four cohorts of four subjects randomised 3:1 to receive omipalisib or placebo (two cohorts received 2 mg twice daily).17 subjects with IPF were enrolled. The most common adverse event was diarrhoea, which was reported by four participants. Dose-related increases in insulin and glucose were observed. Pharmacokinetic analysis demonstrated that exposure in the blood predicts lung exposure. Exposure-dependent inhibition of phosphatidylinositol 3,4,5 trisphosphate and pAKT confirmed target engagement in blood and lungs. 18F-2-fluoro-2-deoxy-d-glucose(FDG)-positron emission tomography/computed tomography scans revealed an exposure-dependent reduction in 18F-FDG uptake in fibrotic areas of the lung, as measured by target-to-background, ratio thus confirming pharmacodynamic activity.This experimental medicine study demonstrates acceptable tolerability of omipalisib in subjects with IPF at exposures for which target engagement was confirmed both systemically and in the lungs.
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Parikh, Aparna Raj, Mihir Rajurkar, Emily E. Van Seventer, Angelo J. Gemma, Jill N. Allen, Lawrence Scott Blaszkowsky, Jeffrey William Clark, et al. "Phase II study of lamivudine in p53 mutant metastatic colorectal cancer (mCRC)." Journal of Clinical Oncology 38, no. 4_suppl (February 1, 2020): 149. http://dx.doi.org/10.1200/jco.2020.38.4_suppl.149.
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149 Background: Non-coding repeat RNAs in cancers are pervasive and “mimic” viruses with activation of pattern recognition receptors and the innate immune response. Many repeat RNAs replicate in cancer genomes through a reverse transcriptional intermediate analogous to retroviruses. Nucleoside reverse transcriptase inhibitors (NRTIs) block this retroviral life cycle to increases repeat RNAs in p53 mutant colon cancer cell cancer lines. We initiated a Phase 2 study of lamivudine (3TC) in TP53 mutant mCRC. Methods: Two-stage design with target accrual of 20 patients (pts) in stage 1 and total of 32. Eligibility: pts with p53 mutant refractory mCRC with progression on or intolerance to 5FU, oxaliplatin and irinotecan and anti-EGFR if RAS WT. RNA sequencing was performed on pre-treatment (tx) and on tx biopsy to evaluate for repeat RNA expression and expression of other genes linked to 3TC response/resistance. Radiation was allowed. 9 pts were treated with 3TC 150 mg po bid for 28-day cycles, the maximum FDA approved dose of 3TC in HIV. Subsequent pts were treated at 600 mg po bid, previously tested in P1 trials. Tumor assessments were performed every 8 weeks until documented disease progression by RECIST 1.1 criteria or drug intolerance. Results: 29/32 pts have been treated. Median age: 60 yrs. (27-82) 18 males, 11 females. 2/ 9 (22%) pts on standard 3TC dosing had stable disease (SD) on single agent 3TC with a duration of tx of 169 and 167 days, respectively. Both pts had an initial drop in CEA upon initiation of 3TC. Of the next 20 pts on high dose 3TC, 19 were evaluable. 4 had SD, for 110, 159, 130 and 228+ days. 14 pts had tx-related adverse events (TRAE). 1 pt with a definite Grade 1 TRAE (fatigue). No pts with Grade ≥3 TRAEs. We obtained pre-tx fresh frozen biopsies on 24/29 pts. Of those with SD, 4 had biopsies and differential expression identified significantly higher HSATII repeat RNA in pts with SD compared to PD. There was an association of decreased epigenetic gene expression in HSATII repeat RNA high tumors. Conclusions: This proof-of-concept study demonstrates the safety and activity of single-agent 3TC. Repeat RNA levels appear to correlate with clinical benefit and can be measured in biopsies. Further combination studies and correlatives are planned. Clinical trial information: NCT03144804.