Feasibility and Evaluation of Automated Methods for Radiolabeling of Radiopharmaceutical Kits with Gallium-68. 2019

Alban Revy, and François Hallouard, and Sandrine Joyeux-Klamber, and Andrea Skanjeti, and Catherine Rioufol, and Marc Fraysse
Hospices Civils de Lyon, Centre Hospitalier de Lyon Sud, Service de Pharmacie, unite de radiopharmacie, 165 Chemin du Grand Revoyet F-69310 Pierre-Benite, France.

OBJECTIVE Recent gallium-68 labeled peptides are of increasing interest in PET imaging in nuclear medicine. Somakit TOC® is a radiopharmaceutical kit registered in the European Union for the preparation of [68Ga]Ga-DOTA-TOC used for the diagnosis of neuroendocrine tumors. Development of a labeling process using a synthesizer is particularly interesting for the quality and reproducibility of the final product although only manual processes are described in the Summary of Product (SmPC) of the registered product. The aim of the present study was therefore to evaluate the feasibility and value of using an automated synthesizer for the preparation of [68Ga]Ga-DOTA-TOC according to the SmPC of the Somakit TOC®. METHODS Three methods of preparation were compared; each followed the SmPC of the Somakit TOC®. Over time, overheads, and overexposure were evaluated for each method. RESULTS Mean±SD preparation time was 26.2±0.3 minutes for the manual method, 28±0.5 minutes for the semi-automated, and 40.3±0.2 minutes for the automated method. Overcost of the semi-automated method is 0.25€ per preparation for consumables and from 0.58€ to 0.92€ for personnel costs according to the operator (respectively, technician or pharmacist). For the automated method, overcost is 70€ for consumables and from 4.06€ to 6.44€ for personnel. For the manual method, extremity exposure was 0.425mSv for the right finger, and 0.350mSv for the left finger; for both the semi-automated and automated method extremity exposure were below the limit of quantification. CONCLUSIONS The present study reports for the first time both the feasibility of using a [68Ga]- radiopharmaceutical kit with a synthesizer and the limits for the development of a fully automated process.

UI MeSH Term Description Entries
D009942 Organometallic Compounds A class of compounds of the type R-M, where a C atom is joined directly to any other element except H, C, N, O, F, Cl, Br, I, or At. (Grant & Hackh's Chemical Dictionary, 5th ed) Metallo-Organic Compound,Metallo-Organic Compounds,Metalloorganic Compound,Organometallic Compound,Metalloorganic Compounds,Compound, Metallo-Organic,Compound, Metalloorganic,Compound, Organometallic,Compounds, Metallo-Organic,Compounds, Metalloorganic,Compounds, Organometallic,Metallo Organic Compound,Metallo Organic Compounds
D011834 Radiation Monitoring The observation, either continuously or at intervals, of the levels of radiation in a given area, generally for the purpose of assuring that they have not exceeded prescribed amounts or, in case of radiation already present in the area, assuring that the levels have returned to those meeting acceptable safety standards. Monitoring, Radiation
D005240 Feasibility Studies Studies to determine the advantages or disadvantages, practicability, or capability of accomplishing a projected plan, study, or project. Feasibility Study,Studies, Feasibility,Study, Feasibility
D005710 Gallium Radioisotopes Unstable isotopes of gallium that decay or disintegrate emitting radiation. Ga atoms with atomic weights 63-68, 70 and 72-76 are radioactive gallium isotopes. Radioisotopes, Gallium
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D015282 Octreotide A potent, long-acting synthetic SOMATOSTATIN octapeptide analog that inhibits secretion of GROWTH HORMONE and is used to treat hormone-secreting tumors; DIABETES MELLITUS; HYPOTENSION, ORTHOSTATIC; HYPERINSULINISM; hypergastrinemia; and small bowel fistula. Octreotide Acetate,Compound 201-995,Octreotide Acetate Salt,SAN 201-995,SM 201-995,SMS 201-995,Sandostatin,Sandostatine,Sandoz 201-995,Compound 201 995,Compound 201995,SAN 201 995,SAN 201995,SM 201 995,SM 201995,SMS 201 995,SMS 201995,Sandoz 201 995,Sandoz 201995
D016273 Occupational Exposure The exposure to potentially harmful chemical, physical, or biological agents that occurs as a result of one's occupation. Exposure, Occupational,Exposures, Occupational,Occupational Exposures
D017076 Computer-Aided Design The use of computers for designing and/or manufacturing of anything, including drugs, surgical procedures, orthotics, and prosthetics. CAD-CAM,Computer-Aided Manufacturing,Computer-Assisted Design,Computer-Assisted Manufacturing,Computer Aided Design,Computer Aided Manufacturing,Computer Assisted Design,Computer Assisted Manufacturing,Computer-Aided Designs,Computer-Assisted Designs,Design, Computer-Aided,Design, Computer-Assisted,Designs, Computer-Aided,Designs, Computer-Assisted,Manufacturing, Computer-Aided,Manufacturing, Computer-Assisted
D057205 Automation, Laboratory Controlled operations of analytic or diagnostic processes, or systems by mechanical or electronic devices. Laboratory Automation
D019275 Radiopharmaceuticals Compounds that are used in medicine as sources of radiation for radiotherapy and for diagnostic purposes. They have numerous uses in research and industry. (Martindale, The Extra Pharmacopoeia, 30th ed, p1161) Radiopharmaceutical

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