Radiopharmaceutical Formulation and Preclinical Testing of ⁶⁸Ga-Labeled DOTA-MGS5 for the Regulatory Approval of a First Exploratory Clinical Trial.

ABSTRACT: The new minigastrin analog DOTA-MGS5 is a promising new candidate for targeting cholecystokinin-2 receptor (CCK2R)-expressing tumors. To enable the clinical translation of PET/CT imaging using ⁶⁸Ga-labeled DOTA-MGS5, different quality and safety aspects need to be considered to comply with the regulatory framework for clinical trial application. The preparation of the radiopharmaceutical was established using a cassette-based automated synthesis unit. Product specifications, including analytical procedures and acceptance criteria, were adopted from Ph. Eur. monographs for other ⁶⁸Ga-labeled radiopharmaceuticals. Non-clinical studies included receptor affinity and cell uptake studies using two different CCK2R-expressing cell lines, as well as pharmacokinetic biodistrib

SUBMITTER: Hormann AA 

PROVIDER: S-EPMC8235783 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature