Multicenter Validation Trial of [18F]AlF-FAPI-74 PET/CT Imaging of Cancer-associated Fibroblasts Using Fibroblast Activation Protein Inhibitors in Various Tumor Types

What this Trial Is About

Researchers are evaluating the detection ability of a new imaging method called [18F]AlF-FAPI-74 PET/CT compared to existing techniques like [18F]FDG PET/CT or conventional imaging in newly diagnosed patients with oesophagogastric adenocarcinoma and pancreatic ductal adenocarcinoma. The goal is to show that this method can better detect cancer in treatment-naive patients and to understand its usefulness in challenging cancer cases. This study is a multicenter trial sponsored by KU Leuven and covers patients with specific clinical stages of these cancers. Participants will undergo [18F]AlF-FAPI-74 PET/CT scans at designated medical centers. The procedure involves fasting for four hours before the scan, followed by intravenous injection of the imaging agent. After a 60-minute wait, a PET/CT scan is performed, including a low-dose CT with oral contrast. Patients will be observed after the scan for any adverse events and asked to complete patient-reported outcomes. If a patient receives neo-adjuvant therapy, additional scans may be done before surgery, with the possibility of a third scan if surgery is delayed. Throughout the study, participants will be monitored from enrollment through 12 months after their first [18F]AlF-FAPI-74 PET/CT. Researchers will assess detection rates, diagnostic accuracy, impact on cancer staging and treatment plans, psychological effects, and adverse events. Detailed analyses include uptake measurements and correlation with pathology. This thorough follow-up aims to provide clear information on the value and safety of this imaging method in cancer care.

Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types