[ 68 Ga]Ga-FAP-2286-Synthesis, Quality Control and Comparison with [ 18 F]FDG PET/CT in a Patient with Suspected Cholangiocellular Carcinoma

[ Ga]Ga-FAP-2286 is a new peptide-based radiopharmaceutical for positron-emission tomography (PET) that targets fibroblast activation protein (FAP). This article describes in detail the automated synthesis of [ Ga]Ga-FAP-2286 using a commercially available synthesis tool that includes quality control for routine clinical applications. The synthesis was performed using a Scintomics GRP-3V module and a GMP grade Ge/ Ga generator. A minor alteration for transferring the eluate to the module was established, eliminating the need for new method programming. Five batches of [ Ga]Ga-FAP-2286 were tested to validate the synthesis. A stability analysis was conducted up to 3 h after production to determine the shelf-life of the finished product. The automated synthesis on the Scintomics GRP-3V synthesis module was found to be compliant with all quality control requirements. The shelf-life of the product was set to 2 h post-production based on the stability study. A patient suffering from cholangiocellular carcinoma that could not be clearly detected by conventional imaging, including a [ F]FDG-PET/CT, highlights the potential use of [ Ga]Ga-FAP-PET/CT.