This exploratory study investigates how an imaging technique called 68Ga-FAPi-46 PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors (cancer associated fibroblasts). The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers.
Additional locations may be listed on ClinicalTrials.gov for NCT04459273.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To define the biodistribution of gallium Ga 68 fibroblast activation protein inhibitor (FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues of patients with various malignancies.
SECONDARY OBJECTIVES:
I. To evaluate the degree of 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET) imaging as opposed to the amount of FAP in excised cancer tissue.
II. To assess the 68Ga-FAPI-46 biodistribution correlation with 18F-fluodeoxyglucose (FDG) biodistribution and to define the frequency of the following phenotypes (FAP+/FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-).
III. Will also assess the correlation of 68Ga-FAPi-46 biodistribution with 68Ga-DOTATATE, or 18F- fluorodopa (DOPA) (FDOPA), depending on the specific indication in patients who had them available.
OUTLINE:
Patients receive 68Ga-FAPi-46 intravenously (IV) then 20-90 minutes later undergo PET/computed tomography (CT). Patients may optionally undergo an FDG PET/CT on study.
Lead OrganizationUCLA / Jonsson Comprehensive Cancer Center
Principal InvestigatorJeremie Calais
