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Journal articles on the topic '68Ge/68Ga generators'

Author: Grafiati

Published: 4 June 2021

Last updated: 1 February 2022

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1

Rösch, Frank. "68Ge/68Ga Generators and 68Ga Radiopharmaceutical Chemistry on Their Way into a New Century." Journal of Postgraduate Medicine, Education and Research 47, no. 1 (2013): 18–25. http://dx.doi.org/10.5005/jp-journals-10028-1052.

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ABSTRACT 68Ga faces a renaissance initiated by the development of new 68Ge/68Ga radionuclide generators, sophisticated 68Ga radiopharmaceuticals, preclinical research and state-of-the-art clincial diagnoses via positron emission tomography/computed tomography (PET/CT). A new type of 68Ge/68Ga generator became commercially available in the first years of the 21st century, with eluates based on hydrochloric acid. These generators provided ‘cationic’ 68Ga instead of ‘inert’ 68Gacomplexes, and opened new pathways of MeIII radiopharmaceutical chemistry. The last decade has seen a 68Ga rush. Increasing interest in generator-based 68Ga radiopharmaceuticals in diagnostic applications has been accompanied by its potential use in the context of diease treatment planning, made possible by the inherent option expressed by theranostics. However, widespread acceptance and clinical application requires optimization of 68Ge/68Ga generators both from chemical and regulatory perspectives. How to cite this article Rösch F. 68Ge/68Ga Generators and 68Ga Radiopharmaceutical Chemistry on Their Way into a New Century. J Postgrad Med Edu Res 2013;47(1):18-25.

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Baimukhanova, Ayagoz, Elena Chakrova, Dimitr Karaivanov, Jan Kozempel, Frank Roesch, and Dmitriy Filosofov. "Production of the positron-emitting radionuclide 68Ga: the radiochemical scheme of radionuclide generator 68Ge → 68Ga." Chemical Bulletin of Kazakh National University, no. 2 (June 30, 2018): 20–26. http://dx.doi.org/10.15328/cb1003.

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68Ga (T1 / 2 = 68 min) in complexes with peptides is used in positron emission tomography for diagnostics of neuroendocrine tumors. The most promising strategy for 68Ga production is usage of the radionuclide generator 68Ge → 68Ga. In this research, the sorption behavior of Ge(IV) and Ga (III) has been studied. The distribution coefficients (Kd) of Ge(IV) on the anion exchange (Dowex 1×8) and cation exchange (Dowex 50×8) resins in various ethanedioic and hydrochloric acid solutions were determined. For each ion exchange resin, four series of measurements were carried out, in which the concentration of oxalic acid was fixed (0.001 M, 0.003 M, 0.005 M, 0.01 M), and the concentrations of hydrochloric acid ranged from 0 to 3 M. Based on the distribution coefficients, the chemical scheme of the radionuclide generator 68Ge → 68Ga has been developed. The chemical system is based on the anion exchange resin Dowex 1×8 and mixture of 0.005 M C2H2O4 / 0.33 M HCl. Several types of the generators with direct and reverse mode of elution were tested and the optimal scheme was determined. Elution of the generators was performed once a day with 8 ml of 0.005 M C2H2O4 / 0.33 M HCl solution. The 68Ga yield and the 68Ge breakthrough are comparable for all the systems.

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3

Schultz, Michael K., Patrick Donahue, Nannette I. Musgrave, Konstantin Zhernosekov, Clive Naidoo, Anatolii Razbash, Izabella Tworovska, et al. "An Increasing Role for 68Ga PET Imaging: A Perspective on the Availability of Parent 68Ge Material for Generator Manufacturing in an Expanding Market." Journal of Postgraduate Medicine, Education and Research 47, no. 1 (2013): 26–30. http://dx.doi.org/10.5005/jp-journals-10028-1053.

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ABSTRACT The use of gallium-68 for molecular imaging is gaining momentum world-wide. While our understanding of 68Ga chemistry, generators, and associated synthesis modules appear to have advanced to a clinically-reliable stage, uncertainty in the supply of radiopharmaceutically-suitable parent is of significant concern. In this work, we examine the current supply of 68Ge in an effort to better understand the potential for expansion of manufacturing to meet an increasing demand for 68Ga. Although specific information on sales and demand of 68Ge is highly business sensitive and thus guarded, our examination finds no shortage in the current supply of 68Ge. On the other hand, increases in the use of 68Ge generators for clinical applications in the United States point to the need for continued support for production at DOE laboratories in the United States to ensure a reliable supply and suggests that new commercial facilities may be needed to meet the increasing demand. How to cite this article Schultz MK, Donahue P, Musgrave NI, Zhernosekov K, Naidoo C, Razbash A, Tworovska I, Dick DW, Watkins GL, Graham MM, Runde W, Clanton JA, Sunderland JJ. An Increasing Role for 68Ga PET Imaging: A Perspective on the Availability of Parent 68Ge Material for Generator Manufacturing in an Expanding Market. J Postgrad Med Edu Res 2013;47(1):26-30.

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4

Rösch, F. "Past, present and future of 68Ge/68Ga generators." Applied Radiation and Isotopes 76 (June 2013): 24–30. http://dx.doi.org/10.1016/j.apradiso.2012.10.012.

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5

Mittal, BR, and Jaya Shukla. "Ga-68: A Versatile PET Imaging Radionuclide." Journal of Postgraduate Medicine, Education and Research 47, no. 1 (2013): 74–76. http://dx.doi.org/10.5005/jp-journals-10028-1059.

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ABSTRACT Gallium-68, a positron emitter, is available via 68Ge/68Ga generators. The simple chemistry and easy availability has increased its application from the clinical diagnosis to personalized therapy and has lot more potential in future. How to cite this article Shukla J, Mittal BR. Ga-68: A Versatile PET Imaging Radionuclide. J Postgrad Med Edu Res 2013;47(1):74-76.

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6

Lin, Mai, David Ranganathan, Tetsuya Mori, Aviv Hagooly, Raffaella Rossin, Michael J. Welch, and Suzanne E. Lapi. "Long-term evaluation of TiO2-based 68Ge/68Ga generators and optimized automation of [68Ga]DOTATOC radiosynthesis." Applied Radiation and Isotopes 70, no. 10 (October 2012): 2539–44. http://dx.doi.org/10.1016/j.apradiso.2012.05.009.

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7

Brambilla, Tania, and João A. Osso. "Preliminary studies on the preparation of 68Ge–68Ga generators at IPEN/CNEN-SP." Nuclear Medicine and Biology 37, no. 6 (August 2010): 718. http://dx.doi.org/10.1016/j.nucmedbio.2010.04.173.

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8

Kang, Daniel, Ulrich Simon, Felix M. Mottaghy, and Andreas T. J. Vogg. "Labelling via [Al18F]2+ Using Precomplexed Al-NODA Moieties." Pharmaceuticals 14, no. 8 (August 20, 2021): 818. http://dx.doi.org/10.3390/ph14080818.

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Over the past 20 years, 68Ga-labelled radiopharmaceuticals have become an important part in clinical routine. However, the worldwide supply with 68Ge/68Ga generators is limited as well as the number of patient doses per batch of 68Ga radiopharmaceutical. In the recent years, a new technique appeared, making use of the ease of aqueous labelling via chelators as with 68Ga but using 18F instead. This technique takes advantage of the strong coordinative bond between aluminium and fluoride, realized in the aqueous cation [Al18F]2+. Most applications to date make use of one-pot syntheses with free Al(III) ions in the system. In contrast, we investigated the labelling approach split into two steps: generating the Al-bearing precursor in pure form and using this Al compound as a precursor in the labelling step with aqueous [18F]fluoride. Hence, no free Al3+ ions are present in the labelling step. We investigated the impact of parameters: temperature, pH, addition of organic solvent, and reaction time using the model chelator NH2-MPAA-NODA. With optimized parameters we could stably achieve a 80% radiochemical yield exerting a 30-min reaction time at 100 °C. This technique has the potential to become an important approach in radiopharmaceutical syntheses.

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9

Baudhuin, Henri, Julie Cousaert, Philippe Vanwolleghem, Geert Raes, Vicky Caveliers, Marleen Keyaerts, Tony Lahoutte, and Catarina Xavier. "68Ga-Labeling: Laying the Foundation for an Anti-Radiolytic Formulation for NOTA-sdAb PET Tracers." Pharmaceuticals 14, no. 5 (May 10, 2021): 448. http://dx.doi.org/10.3390/ph14050448.

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During the preparation of [68Ga]Ga-NOTA-sdAb at high activity, degradation of the tracers was observed, impacting the radiochemical purity (RCP). Increasing starting activities in radiolabelings is often paired with increased degradation of the tracer due to the formation of free radical species, a process known as radiolysis. Radical scavengers and antioxidants can act as radioprotectant due to their fast interaction with formed radicals and can therefore reduce the degree of radiolysis. This study aims to optimize a formulation to prevent radiolysis during the labeling of NOTA derivatized single domain antibody (sdAbs) with 68Ga. Gentisic acid, ascorbic acid, ethanol and polyvinylpyrrolidone were tested individually or in combination to find an optimal mix able to prevent radiolysis without adversely influencing the radiochemical purity (RCP) or the functionality of the tracer. RCP and degree of radiolysis were assessed via thin layer chromatography and size exclusion chromatography for up to three hours after radiolabeling. Individually, the radioprotectants showed insufficient efficacy in reducing radiolysis when using high activities of 68Ga, while being limited in amount due to negative impact on radiolabeling of the tracer. A combination of 20% ethanol (VEtOH/VBuffer%) and 5 mg ascorbic acid proved successful in preventing radiolysis during labeling with starting activities up to 1–1.2 GBq of 68Ga, and is able to keep the tracer stable for up to at least 3 h after labeling at room temperature. The prevention of radiolysis by the combination of ethanol and ascorbic acid potentially allows radiolabeling compatibility of NOTA-sdAbs with all currently available 68Ge/68Ga generators. Additionally, a design is proposed to allow the incorporation of the radioprotectant in an ongoing diagnostic kit development for 68Ga labeling of NOTA-sdAbs.

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10

Amor-Coarasa, Alejandro, Monika Gruca, Sophie Hurez, Seza A. Gulec, Anthony McGoron, and John W. Babich. "Impact of elution impurities on DOTA and NOTA labeling with two commercial 68Ge/68Ga generators." Journal of Radioanalytical and Nuclear Chemistry 317, no. 3 (July 21, 2018): 1485–90. http://dx.doi.org/10.1007/s10967-018-6011-1.

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11

Lee, Jun-Young, Pyeong-Seok Choi, Seung-Dae Yang, and Jeong-Hoon Park. "TiO2 Decorated Low-Molecular Chitosan a Microsized Adsorbent for a 68Ge/68Ga Generator System." Molecules 26, no. 11 (May 26, 2021): 3185. http://dx.doi.org/10.3390/molecules26113185.

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We report column material for a 68Ge/68Ga generator with acid resistance and excellent adsorption and desorption capacity of 68Ge and 68Ga, respectively. Despite being a core element of the 68Ge/68Ga generator system, research on this has been insufficient. Therefore, we synthesized a low molecular chitosan-based TiO2 (LC-TiO2) adsorbent via a physical trapping method as a durable 68Ge/68Ga generator column material. The adsorption/desorption studies exhibited a higher separation factor of 68Ge/68Ga in the concentration range of HCl examined (0.01 M to 1.0 M). The prepared LC-TiO2 adsorbent showed acid resistance capabilities with >93% of 68Ga elution yield and 1.6 × 10−4% of 68Ge breakthrough. In particular, the labeling efficiency of DOTA and NOTA, by using the generator eluted 68Ga, was quite encouraging and confirmed to be 99.65 and 99.69%, respectively. Accordingly, the resulting behavior of LC-TiO2 towards 68Ge/68Ga adsorption/desorption capacity and stability with aqueous HCl exhibited a high potential for ion-exchange solid-phase extraction for the 68Ge/68Ga generator column material.

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12

Vats, Kusum, Rohit Sharma, Mythili Kameswaran, Drishty Satpati, and Ashutosh Dash. "Single vial cold kits optimized for preparation of gastrin releasing peptide receptor (GRPR)-radioantagonist 68Ga-RM2 using three different 68Ge/68Ga generators." Journal of Pharmaceutical and Biomedical Analysis 163 (January 2019): 39–44. http://dx.doi.org/10.1016/j.jpba.2018.09.045.

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13

Amor-Coarasa, A., M. Gruka, S. Hurez, S. Gulec, A. Mcgoron, and J. Babich. "Comparison of the IGG-100 vs the ITG 68Ge/68Ga generators: impact of impurities on radiolabeling." Nuclear Medicine and Biology 72-73 (July 2019): S47—S48. http://dx.doi.org/10.1016/s0969-8051(19)30319-1.

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14

van Heerden, M. R., K. Cole, N. P. van der Meulen, J. P. Franzidis, and A. Buffler. "Extending the life of SnO2 68Ge/68Ga generators used in the radiolabelling of ion exchange resins." Applied Radiation and Isotopes 158 (April 2020): 109044. http://dx.doi.org/10.1016/j.apradiso.2020.109044.

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15

Briganti, Vittorio, Vincenzo Cuccurullo, Valentina Berti, Giuseppe D. Di Stasio, Flavia Linguanti, Francesco Mungai, and Luigi Mansi. "99mTc-EDDA/HYNIC-TOC is a New Opportunity in Neuroendocrine Tumors of the Lung (and in other Malignant and Benign Pulmonary Diseases)." Current Radiopharmaceuticals 13, no. 3 (November 30, 2020): 166–76. http://dx.doi.org/10.2174/1874471013666191230143610.

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Neuroendocrine tumors (NETs) consist of a relatively rare spectrum of malignancies that can arise from neuroendocrine cells; lung NETs (L-NETs) represent about 25% of primary lung neoplasm and 10% of all carcinoid tumors. Diagnostic algorithm usually takes into consideration chest Xray, contrast-enhanced CT and MRI. Nuclear medicine plays a crucial role in the detection and correct assessment of neoplastic functional status as it provides in vivo metabolic data related to the overexpression of Somatostatin Receptors (SSTRs) and also predicting response to peptide receptor radionuclide therapy (PRRT). 111In-Pentreotide (Octreoscan®) is commercially available for imaging of neuroendocrine tumors, their metastases and the management of patients with NETs. More recently, 99mTc-EDDA/HYNIC-TOC(Tektrotyd®) was introduced into the market and its use has been approved for imaging of patients with L-NETs and other SSTR-positive tumors. 99mTc-EDDA/HYNIC-TOC could also represent a good alternative to 68Ga-DOTA-peptides (DOTA-TOC, DOTA-NOC, DOTATATE) in hospitals or centers where PET/CT or 68Ge/68Ga generators are not available. When compared to 111In-Pentetreotide, Tektrotyd® showed slightly higher sensitivity, in the presence of higher imaging quality and lower radiation exposure for patients. Interesting perspectives depending on the kinetic analysis allowed by Tektrotyd® may be obtained in differential diagnosis of non-small cells lung cancer (NSCLC) versus small cells lung cancer (SCLC) and NETs. An interesting perspective could be also associated with a surgery radio-guided by Tektrotyd® in operable lung tumors, including either NETs and NSCLC.

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16

Ambe, Shizuko. "68Ge68Ga generator with alpha-ferric oxide support." International Journal of Radiation Applications and Instrumentation. Part A. Applied Radiation and Isotopes 39, no. 1 (January 1988): 49–51. http://dx.doi.org/10.1016/0883-2889(88)90091-3.

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17

Eppard, Elisabeth, Natalia S. Loktionova, and Frank Rösch. "68Ge content quality control of 68Ge/68Ga-generator eluates and 68Ga radiopharmaceuticals – A protocol for determining the 68Ge content using thin-layer chromatography." Applied Radiation and Isotopes 91 (September 2014): 92–96. http://dx.doi.org/10.1016/j.apradiso.2014.05.011.

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18

Vyas, Chirag K., Jun Young Lee, Min Goo Hur, Seung Dae Yang, Young Bae Kong, Eun Je Lee, and Jeong Hoon Park. "Chitosan-TiO2 composite: A potential 68Ge/68Ga generator column material." Applied Radiation and Isotopes 149 (July 2019): 206–13. http://dx.doi.org/10.1016/j.apradiso.2019.04.016.

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19

Kvaternik, Herbert, Elisabeth Plhak, Daniel Paul, Bernhard Rumpf, and Reingard Aigner. "68Ge/68Ga-generator: a radionuclide source or an approved drug?" Nuclear Medicine and Biology 96-97 (May 2021): S100. http://dx.doi.org/10.1016/s0969-8051(21)00432-7.

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20

Vats, Kusum, Rohit Sharma, Haladhar D. Sarma, Drishty Satpati, and Ashutosh Dash. "68Ga-labeled HBED-CC Variant of uPAR Targeting Peptide AE105 Compared with 68Ga-NODAGA-AE105." Anti-Cancer Agents in Medicinal Chemistry 18, no. 9 (January 3, 2019): 1289–94. http://dx.doi.org/10.2174/1871520618666180316152618.

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Aims: The urokinase Plasminogen Activator Receptors (uPAR) over-expressed on tumor cells and their invasive microenvironment are clinically significant molecular targets for cancer research. uPARexpressing cancerous lesions can be suitably identified and their progression can be monitored with radiolabeled uPAR targeted imaging probes. Hence this study aimed at preparing and evaluating two 68Ga-labeled AE105 peptide conjugates, 68Ga-NODAGA-AE105 and 68Ga-HBED-CC-AE105 as uPAR PET-probes. Method: The peptide conjugates, HBED-CC-AE105-NH2 and NODAGA-AE105-NH2 were manually synthesized by standard Fmoc solid phase strategy and subsequently radiolabeled with 68Ga eluted from a commercial 68Ge/68Ga generator. In vitro cell studies for the two radiotracers were performed with uPAR positive U87MG cells. Biodistribution studies were carried out in mouse xenografts with the subcutaneously induced U87MG tumor. Results: The two radiotracers, 68Ga-NODAGA-AE105 and 68Ga-HBED-CC-AE105 that were prepared in >95% radiochemical yield and >96% radiochemical purity, exhibited excellent in vitro stability. In vivo evaluation studies revealed higher uptake of 68Ga-HBED-CC-AE105 in U87MG tumor as compared to 68Ga-NODAGAAE105; however, increased lipophilicity of 68Ga-HBED-CC-AE105 resulted in slower clearance from blood and other non-target organs. The uPAR specificity of the two radiotracers was ascertained by significant (p<0.05) reduction in the tumor uptake with a co-injected blocking dose of unlabeled AE-105 peptide. Conclusion: Amongst the two radiotracers studied, the neutral 68Ga-NODAGA-AE105 with more hydrophilic chelator exhibited faster clearance from non-target organs. The conjugation of HBED-CC chelator (less hydrophilic) resulted in negatively charged 68Ga-HBED-CC-AE105 which was observed to have high retention in blood that decreased target to non-target ratios.

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21

Ebenhan, Thomas, Isabel Schoeman, Daniel D. Rossouw, Anne Grobler, Biljana Marjanovic-Painter, Judith Wagener, Hendrik G. Kruger, Mike M. Sathekge, and Jan Rijn Zeevaart. "Evaluation of a Flexible NOTA-RGD Kit Solution Using Gallium-68 from Different 68Ge/68Ga-Generators: Pharmacokinetics and Biodistribution in Nonhuman Primates and Demonstration of Solitary Pulmonary Nodule Imaging in Humans." Molecular Imaging and Biology 19, no. 3 (October 14, 2016): 469–82. http://dx.doi.org/10.1007/s11307-016-1014-1.

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22

Roesch, Frank, and Patrick J. Riss. "The Renaissance of the 68Ge/68Ga Radionuclide Generator Initiates New Developments in 68Ga Radiopharmaceutical Chemistry." Current Topics in Medicinal Chemistry 10, no. 16 (November 1, 2010): 1633–68. http://dx.doi.org/10.2174/156802610793176738.

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23

Rossouw, Daniel D., and Wouter A. P. Breeman. "Scaled-up radiolabelling of DOTATATE with 68Ga eluted from a SnO2-based 68Ge/68Ga generator." Applied Radiation and Isotopes 70, no. 1 (January 2012): 171–75. http://dx.doi.org/10.1016/j.apradiso.2011.07.016.

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24

Pandey, Usha, Aruna Korde, Archana Mukherjee, Ajit Shinto, K. K. Kamaleswaran, Raghi P. Jose, Naresh Gamre, and Ashutosh Dash. "Clinical experience with indigenous kit-based preparation of 68Ga-DOTATOC using commercial 68Ge/68Ga generator." Applied Radiation and Isotopes 136 (June 2018): 59–64. http://dx.doi.org/10.1016/j.apradiso.2018.02.002.

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25

Piras, Fabiano, Sartini, Zambito, Braccini, Chiellini, Cataldi, Bartoli, de la Fuente, and Erba. "pH-Responsive Carboxymethylcellulose Nanoparticles for 68Ga-WBC Labeling in PET Imaging." Polymers 11, no. 10 (October 5, 2019): 1615. http://dx.doi.org/10.3390/polym11101615.

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Carboxymethylcellulose (CMC) is a well-known pharmaceutical polymer, recently gaining attention in the field of nanomedicine, especially as a polyelectrolyte agent for the formation of complexes with oppositely charged macromolecules. Here, we report on the application of pH-sensitive pharmaceutical grade CMC-based nanoparticles (NP) for white blood cells (WBC) PET imaging. In this context and as an alternative to 99mTc-HMPAO SPECT labeling, the use of 68Ga3+ as PET radionuclide was investigated since, at early time points, it could provide the greater spatial resolution and patient convenience of PET tomography over SPECT clinical practices. Two operator-friendly kit-type formulations were compared, with the intention of radiolabeling within a short time (10 min), under mild conditions (physiological pH, room temperature) and in agreement with the actual clinically applied guidelines. NP were labeled by directly using 68Ga3+ eluted in HCL 0.05 N, from hospital suited 68Ge/68Ga generator and in absence of chelator. The first kit type approach involved the application of 68Ga3+ as an ionotropic gelation agent for in-situ forming NP. The second kit type approach concerned the re-hydration of a proper freeze-dried injectable NP powder. pH-sensitive NP with 250 nm average diameter and 80% labeling efficacy were obtained. The NP dispersant medium, including a cryoprotective agent, was modulated in order to optimize the Zeta potential value (−18 mV), minimize the NP interaction with serum proteins and guarantee a physiological environment for WBC during NP incubation. Time-dependent WBC radiolabeling was correlated to NP uptake by using both confocal and FT-IR microscopies. The ready to use lyophilized NP formulation approach appears promising as a straightforward 68Ga-WBC labeling tool for PET imaging applications.

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26

Asti, Mattia, Giovanni De Pietri, Alessandro Fraternali, Elisa Grassi, Roberto Sghedoni, Federica Fioroni, Frank Roesch, Annibale Versari, and Diana Salvo. "Validation of 68Ge/68Ga generator processing by chemical purification for routine clinical application of 68Ga-DOTATOC." Nuclear Medicine and Biology 35, no. 6 (August 2008): 721–24. http://dx.doi.org/10.1016/j.nucmedbio.2008.04.006.

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27

Andronov, V. G., A. B. Bruskin, A. S. Sevast’yanova, G. E. Kodina, A. V. Ochkin, and G. V. Myasoedova. "Sorption conditioning of eluate of 68Ge/68Ga generator for medical purposes." Radiochemistry 50, no. 5 (October 2008): 535–40. http://dx.doi.org/10.1134/s1066362208050172.

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28

Petrik, Milos, Andrea Schuessele, Susanne Perkhofer, Cornelia Lass-Flörl, Dirk Becker, and Clemens Decristoforo. "Microbial challenge tests on nonradioactive TiO2-based 68Ge/68Ga generator columns." Nuclear Medicine Communications 33, no. 8 (August 2012): 819–23. http://dx.doi.org/10.1097/mnm.0b013e3283543323.

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Benhong, Cao, Li Zongquan, and Wang Yongxian. "68Ge−68Ga generator with alpha-ferric oxide support in trigonal structure." Journal of Radioanalytical and Nuclear Chemistry 238, no. 1-2 (December 1998): 175–78. http://dx.doi.org/10.1007/bf02385376.

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30

Casteleyn, K., R. Franceschini, F. Lunghi, G. Macchi, L. Manes, E. Seccamani, and B. Weckermann. "Preparation of a 68Ge/68Ga generator for ionic gallium 68 production." Applied Radiation and Isotopes 45, no. 3 (March 1994): 395–96. http://dx.doi.org/10.1016/0969-8043(94)90083-3.

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31

Ghosh, Subhajit, Tapas Das, Shishu K. Suman, Haladhar D. Sarma, and Ashutosh Dash. "Preparation and Preliminary Evaluation of 68 Ga-Acridine: An Attempt to Study the Potential of Radiolabeled DNA Intercalator as a PET Radiotracer for Tumor Imaging." Anti-Cancer Agents in Medicinal Chemistry 20, no. 13 (September 14, 2020): 1538–47. http://dx.doi.org/10.2174/1871520620666200502002609.

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Introduction: Acridine is a well-known DNA intercalator and thereby gets easily inserted within DNA. As uncontrolled rapid cell division is one of the primary characteristics of the tumors, it is expected that acridine or its suitable derivatives will have preferential accumulation in the tumorous lesions. Therefore, an attempt was made to radiolabel an acridine derivative with 68Ga and study the potential of the 68Ga-acridine complex as a PET agent for tumor imaging. Methods: 9-aminoacridine was coupled with p-NCS-benzyl-DOTA to render it suitable for labeling with 68Ga. The purified acridine-DOTA conjugate was radiolabeled with 68Ga, eluted from a 68Ge/68Ga radionuclide generator. Various radiolabeling parameters were optimized and the stability of the radiolabeled preparation was studied. The biological behavior of the 68Ga-acridine complex was studied both in vitro and in vivo using Raji cell line and fibrosarcoma tumor bearing Swiss mice, respectively. Results: 68Ga-acridine complex was obtained with ~100% radiochemical purity under the optimized reaction conditions involving incubation of 2mg/mL of ligand at 100°C for 30 minutes. The complex maintained a radiochemical purity of >95% in normal saline and >65% in human blood serum at 3h post-incubation. In vitro cellular study showed (3.2±0.1)% uptake of the radiotracer in the Raji cells. Biodistribution study revealed significant tumor accumulation [(11.41±0.41)% injected activity in per gram] of the radiotracer within 1h postadministration along with uptake in other non-target organs such as, blood, liver, GIT kidney etc. Conclusion: The present study indicates the potential of 68Ga-acridine as a PET agent for imaging of tumorous lesions. However, further detailed evaluation of the agent is warranted to explore its actual potential.

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Viertl, D., S. Baechler, V. Dunet, M. Kosinski, C. Poitry-Yamate, C. Rüegg, J. O. Prior, and F. Buchegger. "68Ga-NODAGA-RGDyK for αvβ3 integrin PET imaging." Nuklearmedizin 50, no. 06 (2011): 225–33. http://dx.doi.org/10.3413/nukmed-0416-11-06.

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Summary Aim: To visualize neovasculature and/or tumour integrin αvβ3 we selected the binding moiety Arg-Gly-Asp-D-Tyr-Lys (RGDyK) coupled to NODAGA for labeling with 68Ga. Methods: NODAGA-RGDyK (ABX) was labeled with the 68Ga eluate from the 68Ge generator IGG100 using the processor unit PharmTracer. Biodistribution was measured in female Hsd mice sacrificed 10, 30, 60 and 90 min after i. v. injection of 68Ga-NODAGA-RGDyK for OLINDA dosimetry extrapolated to humans. Tumour targeting was studied in SCID mice bearing A431 and other tumour transplants using microPET and biodistribution measurements. Results: Effective half-life of 68Ga-NODAGA-RGDyK was ∼25 min for total body and most organs except liver and spleen that showed stable activity retention. With a bladder voiding interval of 0.5 h the calculated effective dose (ED) was 0.012 and 0.016 mSv/MBq for males and females, respectively. Rapid uptake within 10 min was observed in A431 tumours with dynamic PET followed by a slow release. Biodistribution measurements showed a 68Ga-NODAGARGDyK uptake in A431 tumours of 3.4 ± 0.4 and 2.7 ±0.3%ID/g at 1 and 2 h, respectively. Similar uptakes were observed in a mouse and human breast and ovarian cancer xenografts. Co-injection of excess (5 mg/kg) unlabeled NODAGA- RGDyK with the radiotracer reduced tumour uptake at one hour to 0.23 ± 0.01%ID/g, but similarly decreased uptake in normal organs as well. When unlabeled peptide was injected 15 min after 68Ga- NODAGA- RGDyK, uptake diminished particularly in tumour and adrenals, suggestive of a different binding mode compared with other normal tissues. Conclusion: NODAGA- RGDyK was reliably labeled with 68Ga and revealed a predicted ED of 0.014 mSv/MBq. Tumour uptake was rapid and significant and was chased with unlabeled RGDyK in a similar manner as adrenal uptake.

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Chakravarty, Rubel, Rakesh Shukla, Ramu Ram, Avesh Kumar Tyagi, Ashutosh Dash, and Meera Venkatesh. "Development of a nano-zirconia based 68Ge/68Ga generator for biomedical applications." Nuclear Medicine and Biology 38, no. 4 (May 2011): 575–83. http://dx.doi.org/10.1016/j.nucmedbio.2010.10.007.

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Amor-Coarasa, A., M. Schoendorf, M. Meckel, S. Vallabhajosula, and J. W. Babich. "Comprehensive Quality Control of the ITG 68Ge/68Ga Generator and Synthesis of 68Ga-DOTATOC and 68Ga-PSMA-HBED-CC for Clinical Imaging." Journal of Nuclear Medicine 57, no. 9 (April 21, 2016): 1402–5. http://dx.doi.org/10.2967/jnumed.115.171249.

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Nakayama, M., M. Haratake, M. Ono, T. Koiso, K. Harada, H. Nakayama, S. Yahara, Y. Ohmomo, and Y. Arano. "A new 68Ge/68Ga generator system using an organic polymer containing N-methylglucamine groups as adsorbent for 68Ge." Applied Radiation and Isotopes 58, no. 1 (January 2003): 9–14. http://dx.doi.org/10.1016/s0969-8043(02)00268-3.

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36

Saha Das, Sujata, Sankha Chattopadhyay, Md Nayer Alam, Madhusmita, Luna Barua, and Malay Kanti Das. "Preparation and evaluation of SnO2-based 68Ge/68Ga generator made from 68Ge produced through natZn(α,xn) reaction." Applied Radiation and Isotopes 79 (September 2013): 42–47. http://dx.doi.org/10.1016/j.apradiso.2013.04.019.

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37

Eppard, Elisabeth, Natalia S. Loktionova, and Frank Rösch. "Quantitative online isolation of 68Ge from 68Ge/68Ga generator eluates for purification and immediate quality control of breakthrough." Applied Radiation and Isotopes 82 (December 2013): 45–48. http://dx.doi.org/10.1016/j.apradiso.2013.07.020.

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38

Breeman, Wouter A. P., and Alfons M. Verbruggen. "The 68Ge/68Ga generator has high potential, but when can we use 68Ga-labelled tracers in clinical routine?" European Journal of Nuclear Medicine and Molecular Imaging 34, no. 7 (March 2, 2007): 978–81. http://dx.doi.org/10.1007/s00259-007-0387-4.

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39

Wagner, Michael, Johan G. Doverfjord, Joachim Tillner, Gunnar Antoni, Torsten Haack, Martin Bossart, Iina Laitinen, et al. "Automated GMP-Compliant Production of [68Ga]Ga-DO3A-Tuna-2 for PET Microdosing Studies of the Glucagon Receptor in Humans." Pharmaceuticals 13, no. 8 (July 31, 2020): 176. http://dx.doi.org/10.3390/ph13080176.

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Introduction: [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 (previously published as [68Ga]Ga-DO3A-VS-Cys40-S01-GCG) has shown high-affinity specific binding to the glucagon receptor (GCGR) in vitro and in vivo in rats and non-human primates in our previous studies, confirming the suitability of the tracer for drug development applications in humans. The manufacturing process of [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 was automated for clinical use to meet the radiation safety and good manufacturing practice (GMP) requirements. Methods: The automated synthesis platform (Modular-Lab PharmTrace, Eckert & Ziegler, Eurotope, Germany), disposable cassettes for 68Ga-labeling, and pharmaceutical-grade 68Ge/68Ga generator (GalliaPharm®) used in the study were purchased from Eckert & Ziegler. The parameters such as time, temperature, precursor concentration, radical scavenger, buffer concentration, and pH, as well as product purification step, were investigated and optimized. Process optimization was conducted with regard to product quality and quantity, as well as process reproducibility. The active pharmaceutical ingredient starting material DO3A-VS-Cys40-Tuna-2 (GMP-grade) was provided by Sanofi Aventis. Results: The reproducible and GMP-compliant automated production of [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 with on-line documentation was developed. The non-decay-corrected radiochemical yield was 45.2 ± 2.5% (n = 3, process validation) at the end of the synthesis with a labeling synthesis duration of 38 min and a quality controlincluding release procedure of 20 min. The radiochemical purity of the product was 98.9 ± 0.6% (n = 17) with the total amount of the peptide in the preparation of 48 ± 2 µg (n = 3, process validation). Radionuclidic purity, sterility, endotoxin content, residual solvent content, and sterile filter integrity tests met the acceptance criteria. The product was stable at ambient temperature for at least 2 h. Conclusion: The fully automated GMP-compliant manufacturing process was developed and thoroughly validated. The resulting [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 was used in a clinical study for accurate quantification of GCGR occupancy by a dual anti-diabetic drug in vivo in humans.

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Mundy, J., J. Zweit, B. Pratt, and A. Gilhespy-Muskett. "Development of an-in-house, low-cost 68Ge/68Ga generator for clinical PET." Nuclear Medicine Communications 16, no. 4 (April 1995): 246. http://dx.doi.org/10.1097/00006231-199504000-00133.

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de Blois, Erik, Ho Sze Chan, Clive Naidoo, Deidre Prince, Eric P. Krenning, and Wouter A. P. Breeman. "Characteristics of SnO2-based 68Ge/68Ga generator and aspects of radiolabelling DOTA-peptides." Applied Radiation and Isotopes 69, no. 2 (February 2011): 308–15. http://dx.doi.org/10.1016/j.apradiso.2010.11.015.

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Rangarajan, Venkatesh, Piyush Chandra, Bhakti Shetye, Rubel Chakravarty, Archana Mukherjee, Usha Pandey, AshishKumar Jha, et al. "Initial clinical experience with 68Ga-DOTA-NOC prepared using 68Ga from nanoceria-polyacrylonitrile composite sorbent-based 68Ge/68Ga generator and freeze-dried DOTA-NOC kits." World Journal of Nuclear Medicine 16, no. 2 (2017): 140. http://dx.doi.org/10.4103/1450-1147.203072.

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Lee, Jun Young, Chirag K. Vyas, Bo-Ram Kim, Hee Jung Kim, Min Goo Hur, Seung Dae Yang, Jeong Hoon Park, and Sang Wook Kim. "Acid resistant zirconium phosphate for the long term application of 68Ge/68Ga generator system." Applied Radiation and Isotopes 118 (December 2016): 343–49. http://dx.doi.org/10.1016/j.apradiso.2016.09.025.

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Chakravarty, Rubel, Sudipta Chakraborty, Rakesh Shukla, Jitendra Bahadur, Ramu Ram, Subhasish Mazumder, Haladhar Dev Sarma, Avesh Kumar Tyagi, and Ashutosh Dash. "Mechanochemical synthesis of mesoporous tin oxide: a new generation nanosorbent for 68Ge/68Ga generator technology." Dalton Transactions 45, no. 34 (2016): 13361–72. http://dx.doi.org/10.1039/c6dt01921h.

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Nanabala, Raviteja, Muhammed K. Anees, Arun Sasikumar, Ajith Joy, and M. R. A. Pillai. "Preparation of [68Ga]PSMA-11 for PET–CT imaging using a manual synthesis module and organic matrix based 68Ge/68Ga generator." Nuclear Medicine and Biology 43, no. 8 (August 2016): 463–69. http://dx.doi.org/10.1016/j.nucmedbio.2016.05.006.

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Washiyama, Kohshin, Ryohei Amano, Tadashi Nozaki, Koji Ogawa, Kotaro Nagatsu, Minoru Sakama, Tatuo Ido, and Hiroshi Yamaguchi. "Manufacture and Utilization of a Low-level Radioactive 68Ge/68Ga Generator in a Radiochemistry Laboratory Course." Japanese Journal of Radiological Technology 71, no. 10 (2015): 983–93. http://dx.doi.org/10.6009/jjrt.2015_jsrt_71.10.983.

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Cressier, Damien, Steve Oelsner, Gary Hunter, Linda Quarin, Nathalie Methot, Dennis Wester, and Louisa Barré. "Smoothened titania particles to improve radionuclide separation and their application to the development of a novel [68Ge]/[68Ga] generator." RSC Advances 5, no. 37 (2015): 29319–24. http://dx.doi.org/10.1039/c5ra03177j.

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48

Chakraborty, Sudipta, Rubel Chakravarty, Haladhar D. Sarma, Ashutosh Dash, and M. R. A. Pillai. "The Practicality of Nanoceria-PAN-Based 68Ge/68Ga Generator Toward Preparation of 68Ga-Labeled Cyclic RGD Dimer as a Potential PET Radiotracer for Tumor Imaging." Cancer Biotherapy and Radiopharmaceuticals 28, no. 1 (February 2013): 77–83. http://dx.doi.org/10.1089/cbr.2012.1252.

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Prince, Deidré, Daniel Rossouw, Claudia Davids, and Sietske Rubow. "Development and Evaluation of User-Friendly Single Vial DOTA-Peptide Kit Formulations, Specifically Designed for Radiolabelling with 68Ga from a Tin Dioxide 68Ge/68Ga Generator." Molecular Imaging and Biology 19, no. 6 (March 24, 2017): 817–24. http://dx.doi.org/10.1007/s11307-017-1077-7.

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YAMASHITA, Masato, Hitoshi HORII, Yoshio IMAHORI, Norihiko MIZUKAWA, Yoshihiko MORIYAMA, and Tadayoshi MIYAZAKI. "A trial using Tin (IV) oxide for reduction of 68Ge contamination in eluates from an lonic 68Ga generator." RADIOISOTOPES 35, no. 3 (1986): 133–35. http://dx.doi.org/10.3769/radioisotopes.35.3_133.

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