This exploratory trial is evaluating a new imaging tracer (68Ga-FAPi-46) with positron emission tomography (PET)/computed tomography (CT) to determine where and to which degree the tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues (the biodistribution) in patients with solid tumors or hematologic (blood) cancers. 68Ga-FAPI-46 is a tracer used in PET scans. It attaches to a protein (called FAP) found on certain support cells in the body, called fibroblasts. Around many tumors, these fibroblasts become very active — we call them cancer-associated fibroblasts. Because of this, 68Ga-FAPI-46 PET scans can light up areas where cancer is located.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07118176.
Locations matching your search criteria
United States
California
Los Angeles
UCLA / Jonsson Comprehensive Cancer CenterStatus: Active
Contact: Jeremie Calais
PRIMARY OBJECTIVE:
I. To define the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) in normal and cancer tissues of patients with various malignancies measured by standardized uptake values (SUV).
SECONDARY OBJECTIVE:
I. To assess the 68Ga-FAPI-46 biodistribution correlation with fludeoxyglucose F-18 (18F-FDG) biodistribution and to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-).
OUTLINE:
Patients receive 68Ga-FAPi-46 intravenously (IV) and then, 20-90 minutes later, undergo PET/CT over 20-50 minutes. Patients may undergo optional 18F-FDG PET/CT on study.
Lead OrganizationUCLA / Jonsson Comprehensive Cancer Center
Principal InvestigatorJeremie Calais
