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**[68Ga]Ga-DOTA-SA-FAPi** (also referred to as [68Ga]Ga-DOTA.SA.FAPi) is an investigational, small-molecule, quinoline-based radiodiagnostic PET tracer targeting fibroblast activation protein (FAP). It consists of the potent FAP inhibitor UAMC1110 conjugated to the chelator DOTA via a squaric acid (SA) linker, radiolabeled with the positron-emitting isotope gallium-68 (68Ga). FAP is highly overexpressed on cancer-associated fibroblasts (CAFs) in the tumor microenvironment of over 90% of epithelial malignancies, as well as in active fibrotic remodeling associated with cardiovascular and renal diseases. [68Ga]Ga-DOTA-SA-FAPi is being evaluated as a diagnostic and staging tool in various cancers, including breast cancer, sarcoma, adrenocortical carcinoma, hepatocellular carcinoma, gallbladder cancer, lung cancer, and thyroid cancers (such as medullary thyroid cancer and radioiodine-refractory differentiated thyroid cancer), where it has demonstrated high tumor-to-background contrast and favorable diagnostic performance compared to [18F]F-FDG. It is also under investigation for non-oncological indications, such as arrhythmogenic right ventricular cardiomyopathy (ARVC) and chronic kidney disease (CKD) to assess myocardial and renal fibrosis. The tracer was developed through a collaboration involving Johannes Gutenberg University Mainz, the University of Antwerp, and Positronpharma, with clinical evaluation led by groups at the All India Institute of Medical Sciences (AIIMS) and the Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh.
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