Phase 2 Evaluation of 68Ga-FAPI-46 PETCT Scan for Detecting Cancer-Associated Fibroblasts and Surgical Outcomes in Localized Pancreatic Ductal Adenocarcinoma

What this Trial Is About

Researchers are evaluating the use of 68Ga-FAPI-46 PETCT scans to detect cancer-associated fibroblasts CAFs in patients with localized pancreatic ductal adenocarcinoma PDA, a type of pancreatic cancer that has not spread beyond the pancreas. CAFs are connective tissue cells near cancerous areas that express a protein called fibroblast activation protein FAP. This study aims to determine how well the 68Ga-FAPI-46 PET scan detects these cells and to develop a model to predict surgical benefits for potentially resectable PDA. Participants receive an intravenous injection of 68Ga-FAPI-46 and then wait 60 minutes for the compound to attach to FAP present on PDA cells. They undergo PETCT scans lasting about 30 minutes at baseline before standard care, up to two scans about eight weeks apart during standard care restaging, and a final scan within four weeks after surgical resection if surgery occurs. The PETCT combines two imaging methods to provide detailed pictures of cancer-associated areas. During the study, participants undergo multiple PETCT scans and are followed for up to five years after completing the imaging procedures. Researchers collect data on the scans ability to detect CAFs, relationships between PET scan results and various biomarkers like CA19-9 and ctDNA, and how scan results correlate with cancer staging tests. This long-term follow-up helps assess the diagnostic performance of the 68Ga-FAPI-46 PETCT in managing PDA.

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