This early phase I trial determines where and to what degree the tracer [68Ga] Ga-FAPI-04 accumulates in normal and cancer tissues in patients with high grade neuroendocrine cancer. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research [68Ga] Ga-FAPI-04. Because some cancers take up [68Ga] Ga-FAPI-04, it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient’s body.
Additional locations may be listed on ClinicalTrials.gov for NCT07132645.
Locations matching your search criteria
United States
Michigan
Ann Arbor
University of Michigan Comprehensive Cancer CenterStatus: Active
Contact: Benjamin Viglianti
Phone: 734-936-5385
PRIMARY OBJECTIVE:
I. To obtain basic information on the biodistribution and pharmacokinetics of Gallium Ga 68-DOTA-FAPI-04 ([68Ga] GaFAPI-04) in cancer patients with neuroendocrine tumors.
SECONDARY OBJECTIVE:
I. To compare the diagnostic performance of [68Ga] Ga-FAPI-04 in cancer patients with high grade neuroendocrine tumors with the current standard of care imaging with [68Ga] Ga-DOTATATE.
OUTLINE:
Patients receive [68Ga] Ga-FAPI-04 intravenously (IV), followed 1 hour later by positron emission tomography (PET)/computed tomography (CT) scan over approximately 25 minutes.
After completion of study intervention, patients are followed up at 24 hours.
Lead OrganizationUniversity of Michigan Comprehensive Cancer Center
Principal InvestigatorBenjamin Viglianti
