Quantitative In Vivo 68Ga-FAPI-46 PET Imaging of Cancer-Associated Fibroblasts in Pancreatic Ductal Adenocarcinoma

What this Trial Is About

Researchers are evaluating the use of 68Ga-FAPI-46 PET/CT scans to detect cancer-associated fibroblasts (CAFs) in patients with localized pancreatic ductal adenocarcinoma (PDA) that has not spread to other parts of the body. This phase II trial aims to determine how well this imaging method can identify and measure CAFs that express fibroblast activation protein (FAP), which is found in PDA cells but not in healthy tissues. The study also seeks to develop a model to predict the benefit or futility of surgery using these imaging biomarkers alongside other disease markers. Participants receive an intravenous injection of 68Ga-FAPI-46 and wait 60 minutes for the compound to attach to FAP proteins in the PDA cells. They then undergo PET/CT scans lasting about 30 minutes at several points: before starting standard of care (SOC) therapy, up to two times approximately eight weeks apart during SOC restaging visits, and once more within four weeks after SOC surgical resection if surgery is performed. This imaging combines PET and CT scans to create detailed pictures of the tumor and surrounding tissues. During the study, participants will be closely monitored with these scans and other tests over a period of up to five years. Researchers will assess the diagnostic performance of 68Ga-FAPI-46 PET imaging, examine its relationship with other biomarkers such as CA19-9 and circulating tumor DNA, and review how the imaging relates to standard staging methods. This long-term follow-up helps to understand the potential role of 68Ga-FAPI-46 PET/CT in managing localized PDA and guiding surgical decisions.

Investigational Scan (68Ga-FAPI-46 PET/CT) for Imaging of Cancer-Associated Fibroblasts for Localized Pancreatic Ductal Adenocarcinoma