Automated synthesis of [ 68 Ga]Ga-FAPI-46 without pre-purification of the generator eluate on three common synthesis modules and two generator types.

Autor: Alfteimi A; Department of Nuclear Medicine, Molecular Diagnostic Imaging and Therapy, University Hospital of Schleswig-Holstein (UKSH), Campus Kiel, Karl Lennert Cancer Center North, Feld-Str. 21 (Haus L), 24105, Kiel, Germany., Lützen U; Department of Nuclear Medicine, Molecular Diagnostic Imaging and Therapy, University Hospital of Schleswig-Holstein (UKSH), Campus Kiel, Karl Lennert Cancer Center North, Feld-Str. 21 (Haus L), 24105, Kiel, Germany., Helm A; Department of Nuclear Medicine, Molecular Diagnostic Imaging and Therapy, University Hospital of Schleswig-Holstein (UKSH), Campus Kiel, Karl Lennert Cancer Center North, Feld-Str. 21 (Haus L), 24105, Kiel, Germany., Jüptner M; Department of Nuclear Medicine, Molecular Diagnostic Imaging and Therapy, University Hospital of Schleswig-Holstein (UKSH), Campus Kiel, Karl Lennert Cancer Center North, Feld-Str. 21 (Haus L), 24105, Kiel, Germany., Marx M; Department of Nuclear Medicine, Molecular Diagnostic Imaging and Therapy, University Hospital of Schleswig-Holstein (UKSH), Campus Kiel, Karl Lennert Cancer Center North, Feld-Str. 21 (Haus L), 24105, Kiel, Germany., Zhao Y; Department of Nuclear Medicine, Molecular Diagnostic Imaging and Therapy, University Hospital of Schleswig-Holstein (UKSH), Campus Kiel, Karl Lennert Cancer Center North, Feld-Str. 21 (Haus L), 24105, Kiel, Germany., Zuhayra M; Department of Nuclear Medicine, Molecular Diagnostic Imaging and Therapy, University Hospital of Schleswig-Holstein (UKSH), Campus Kiel, Karl Lennert Cancer Center North, Feld-Str. 21 (Haus L), 24105, Kiel, Germany. maaz.zuhayra@uksh.de.
Jazyk: angličtina
Zdroj: EJNMMI radiopharmacy and chemistry [EJNMMI Radiopharm Chem] 2022 Jul 29; Vol. 7 (1), pp. 20. Date of Electronic Publication: 2022 Jul 29.
DOI: 10.1186/s41181-022-00172-1
Abstrakt: Background: The recent development of quinoline-based radiotracers, which act as fibroblast activation protein inhibitors (FAPIs), has shown promising preclinical and clinical advantages. [ 68 Ga]Ga-FAPI-46 is a new radiotracer for in vivo detection of the fibroblast activation protein by positron emission tomography (PET). Recently, the automated synthesis of [ 68 Ga]Ga-FAPI-46 was reported based on pre-concentration and purification of the generator eluate by using a cation exchange-cartridge. Our aim was to simplify the synthesis and shorten the automated synthesis of [ 68 Ga]Ga-FAPI-46 to make it accessible and thus even more attractive to a broader clinical and scientific community.
Results: We developed and evaluated the GMP compliant automatic synthesis of [ 68 Ga]Ga-FAPI-46 using two different 68 Ge/ 68 Ga generators (an Eckert & Ziegler, GalliaPharm generator, 1.85 GBq/50 mCi and an iThemba generator, 1.85 GBq/50 mCi) Somerset West, South Africa) and three different commercial and customized systems: the EasyOne module from Trasis; the GaSy module from Synthra with a customized synthesis template and a customized single use cassette. Additionally, the automatic synthesis of [ 68 Ga]Ga-FAPI-46 was established on a GallElut synthesis module from Scintomics with fixed tubing.
Conclusions: Independent of the synthesis modules or the generators employed we were able to complete the synthesis of [ 68 Ga]Ga-FAPI-46 in 12 min including the process of purification and formulation. In all cases, the final products showed more than 99.5% chemical purity and the radiochemical yield reached around 92.5% (decay corrected). All quality control parameters (e.g. sterility, stability and radiochemical purity) were conform to the European Pharmacopoeia.
(© 2022. The Author(s).)
Databáze: MEDLINE
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