Automated Synthesis of 68Ga-DOTA-TOC with a Cationic Purification System: Evaluation of Methodological and Technical Aspects in Routine Preparations

摘要

Background and Objective: Gallium-68 is a PET isotope available in each nuclear medicinedepartments, even those not equipped with a cyclotron, since it is easily obtained by eluting compactand transportable generator system. The preparation of Ga-68 DOTA-labeled compounds is performedby remotely controlled automated systems developed in order to ensure production efficiency, reproducibilityof the results, fast reaction time, to facilitate the synthesis and minimize the radiation exposure.Many automatic synthesis systems are available on the radiopharmaceutical market, however, theyrequires some technical adaptations for routine use. We reported the [68Ga]Ga-DOTA-TOC productionby automated cassette-based theranostic synthesizer system used in combination with a disposable GMPgrade cassette system for cationic purification.Methods: The synthesizer is integrated with the 68Ge/68Ga generator systems and it allows to performelution, eluate purification and radiolabeling in about 38 minutes. We have performed in 2 year (January2016 - January 2018) over 100 [68Ga]Ga-DOTA-TOC preparations.Results: The average synthesis yield of radiopharmaceutical production was 54.4 ± 2.3 % and the radiochemicalpurity average was found 96.94 ± 0.74 %. Only three [68Ga]Ga-DOTA-TOC preparations havefailed.Conclusion: The methodology and the adopted technical solutions allowed to obtain a high qualityradiopharmaceutical product as required by the European Pharmacopoeia.