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Automated GMP compliant production of [18F]AlF-NOTA-octreotide by Tshibangu, Térence; Cawthorne, Christopher; Serdons, Kim; Pauwels, Elin; Gsell, Willy; Bormans, Guy; Deroose, Christophe M.; Cleeren, Frederik is a Medicine article available to read on EtoBox.
What is Automated GMP compliant production of [18F]AlF-NOTA-octreotide about?
## Abstract ## Background Gallium-68 labeled synthetic somatostatin analogs for PET/CT imaging are the current gold standard for somatostatin receptor imaging in neuroendocrine tumor patients. Despite good imaging properties, their use in clinical practice is hampered by the low production levels of^68^Ga eluted from a^68^Ge/^68^Ga generator. In contrast,^18^F-tracers can be produced in large quantities allowing centralized production and distribution to distant PET centers. [^18^F]AlF-NOTA-octreotide is a promising tracer that combines a straightforward Al^18^F-based production procedure with excellent in vivo pharmacokinetics and specific tumor uptake, demonstrated in SSTR2 positive tumor mice. However, advancing towards clinical studies with [^18^F]AlF-NOTA-octreotide requires the development of an efficient automated GMP production process and additional preclinical studies are necessary to further evaluate the in vivo properties of [^18^F]AlF-NOTA-octreotide. In this study, we present the automated GMP production of [^18^F]AlF-NOTA-octreotide on the Trasis AllinOne® radio-synthesizer platform and quality control of the drug product in accordance with GMP. Further, radiometabol
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- Author
- Tshibangu, Térence; Cawthorne, Christopher; Serdons, Kim; Pauwels, Elin; Gsell, Willy; Bormans, Guy; Deroose, Christophe M.; Cleeren, Frederik
- Publisher
- Springer (Biomed Central Ltd.); Cham: Springer Internat. Publ., 2016-; Springer Science and Business Media LLC (ISSN 2365-421X)
- Published
- 2020
- Language
- EN
- Field
- Medicine (Health Sciences)