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

[ Vol. 11 , Issue. 2 ]

Author(s):

Licia Uccelli*, Alessandra Boschi, Corrado Cittanti, Petra Martini, Luca Lodi, Elisa Zappaterra, Simona Romani, Samanta Zaccaria, Davide Cecconi, Ilaria Rambaldi, Ivan Santi, Stefano Panareo, Melchiore Giganti and Mirco Bartolomei   Pages 130 - 137 ( 8 )

Abstract:


Background and Objective: Gallium-68 is a PET isotope available in each nuclear medicine departments, even those not equipped with a cyclotron, since it is easily obtained by eluting compact and transportable generator system. The preparation of Ga-68 DOTA-labeled compounds is performed by remotely controlled automated systems developed in order to ensure production efficiency, reproducibility of 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, they requires some technical adaptations for routine use. We reported the [68Ga]Ga-DOTA-TOC production by automated cassette-based theranostic synthesizer system used in combination with a disposable GMP grade cassette system for cationic purification.

Methods: The synthesizer is integrated with the 68Ge/68Ga generator systems and it allows to perform elution, eluate purification and radiolabeling in about 38 minutes. We have performed in 2 year (January 2016 - January 2018) over 100 [68Ga]Ga-DOTA-TOC preparations.

Results: The average synthesis yield of radiopharmaceutical production was 54.4 ± 2.3 % and the radiochemical purity average was found 96.94 ± 0.74 %. Only three [68Ga]Ga-DOTA-TOC preparations have failed.

Conclusion: The methodology and the adopted technical solutions allowed to obtain a high quality radiopharmaceutical product as required by the European Pharmacopoeia.

Keywords:

68Ga-labeled-peptides, [68Ga]Ga-DOTA-TOC, positron emission tomography, automated radio-synthesis, tumor imaging, radiopharmaceutical.

Affiliation:

Morphology, Surgery and Experimental Medicine Department, University of Ferrara, Ferrara, Morphology, Surgery and Experimental Medicine Department, University of Ferrara, Ferrara, Morphology, Surgery and Experimental Medicine Department, University of Ferrara, Ferrara, Legnaro National Laboratories, Italian National Institute for Nuclear Physics (LNL-INFN), Legnaro (PD), Nuclear Medicine Unit, University Hospital, Ferrara (FE), Nuclear Medicine Unit, University Hospital, Ferrara (FE), Nuclear Medicine Unit, University Hospital, Ferrara (FE), Nuclear Medicine Unit, University Hospital, Ferrara (FE), Morphology, Surgery and Experimental Medicine Department, University of Ferrara, Ferrara, Nuclear Medicine Unit, University Hospital, Ferrara (FE), Nuclear Medicine Unit, University Hospital, Ferrara (FE), Nuclear Medicine Unit, University Hospital, Ferrara (FE), Nuclear Medicine Unit, University Hospital, Ferrara (FE), Nuclear Medicine Unit, University Hospital, Ferrara (FE)

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