This early phase I trial studies a new imaging technique called fibroblast activating protein (FAP) positron emission tomography (PET)/computed tomography (CT) for evaluating thickening or scarring of tissue (fibrosis) in patients with diseases or conditions that may cause fibrosis. 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, [18F]-FAPi74. Because some cancers and fibrotic tissues take up [18F]-FAPi74, 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 NCT06413355.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer CenterStatus: Active
Contact: Mark A. Sellmyer
Phone: 215-573-3212
PRIMARY OBJECTIVES:
I. Measure the uptake of fluorine F 18 FAPI-74 ([18F]-FAPi74) in primary and regionally metastatic sites of head and neck tumors using PET, including dynamic imaging to generate time activity curves to develop optimal imaging methodology for this new radiotracer. (Head and neck cancer cohort)
II. To determine the association between fibroblast activating protein (FAP) signal intensity in lungs on FAP PET and lung structural damage in adults with post tubercular lung disease (PTLD). (PTLD cohort)
III. To evaluate FAP activity in the heart in subjects with metabolically active cardiac sarcoidosis. (Cardiac sarcoidosis cohort)
IV. Early phase study to collect and characterize FAP expression imaging in suspected fibrotic tissues related to a variety of suspected fibrosis-inducing conditions, including cancers and non-oncologic conditions, using [F-18]-
FAPI-74 PET/CT. (Exploratory cohort)
SECONDARY OBJECTIVES:
I. Measure the lesional sensitivity and specificity of [18F]-FAPi74 imaging test against the pathologic evaluation of the primary tumor and regional lymph node metastases as the gold standard. (Head and neck cancer cohort)
II. Correlate FAP expression measured by [18F]-FAPi74 imaging and immunohistochemistry (IHC) on intratumoral and peri-tumor cancer fibroblasts measured by [18F]-FAPi74 imaging and IHC. (Head and neck cancer cohort)
III. Determine the ability of [18F]-FAPi74 to predict high risk pathologic features (e.g., extranodal extension) compared to standard of care imaging that may include CT neck with contrast cross sectional imaging or fludeoxyglucose (FDG)-PET, if available. (Head and neck cancer cohort)
IV. To evaluate the effect of immunosuppression therapy on FAPi uptake in the heart. (Cardiac sarcoidosis cohort)
V. To correlate [18F]-FAPI-74 uptake measures with clinical outcomes after therapeutic intervention, when applicable. (Exploratory cohort)
VI. To correlate [18F]-FAPI-74 uptake as a tool to stratify patients for potential therapeutic intervention. (Exploratory cohort)
OUTLINE:
Patients receive [18F]-FAPi74 intravenously (IV) then undergo PET/CT scan over 20-30 minutes. Patients may optionally receive [18F]-FAPi74 IV and undergo an additional PET/CT scan and/or undergo blood sample collection on study.
After completion of study intervention, patients are followed up at 24 hours.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorMark A. Sellmyer
