Phase I trial of [68Ga]Ga-FAPI-04, a fibroblast activation protein inhibitor for imaging.

This early phase I trial at University of Michigan Rogel Cancer Center evaluates the biodistribution and uptake of [68Ga]Ga-FAPI-04—a tracer that binds fibroblast activation protein—in patients with high-grade neuroendocrine neoplasms. Patients receive an IV injection followed by a PET/CT scan to assess tracer accumulation, providing anatomical context and guiding future diagnostic research; DOTATATE PET is standard for many NETs, and FAPI may visualize SSTR-negative/dedifferentiated disease and desmoplastic stroma to improve staging.