Using FAPI-74 PETCT Scans to Detect Fibrosis in Adults with Various Fibrotic Conditions Including Cancer and Sarcoidosis

What this Trial Is About

Researchers are evaluating the use of Fibroblast Activating Protein FAP PETCT imaging to detect fibrosis caused by various medical conditions where fibrosis is believed to lead to harmful effects and poor outcomes. This phase 1 basket protocol includes patients with fibrosis-inducing diseases such as cancer-associated fibrosis, post-infection, post-radiation, pre or post-transplant, and fibrosis affecting the heart, liver, kidneys, or lungs. The study aims to expand with additional imaging groups as needed to gather clinical data supporting the use of FAP-targeted therapies. Participants will receive an intravenous injection of approximately 6.0 to 8.0 mCi of the radiopharmaceutical F-18-FAPI-74, which binds to fibroblast activating protein and allows visualization via PETCT scan from head to mid-thigh. Some participants may have a second PETCT scan at a later time to observe changes in fibrosis naturally or in response to therapy. The study includes specific cohorts such as head and neck cancer, post tubercular lung disease, cardiac sarcoidosis, and an exploratory group. During the study, participants will undergo PETCT imaging sessions to measure the distribution and uptake of F-18-FAPI-74 in tissues affected by fibrosis. Imaging results will be compared with clinical pathology and laboratory tests related to fibrosis. The study does not use imaging results to guide treatment decisions, which remain the responsibility of the treating physicians. The primary outcomes focus on PETCT image analysis over three years. Participation requires informed consent and adherence to imaging procedures.

FAPI-74 PET/CT in Adults With Fibrosis