Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC)

This is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of \[¹⁸F\]FAPI-74 PET/CT in the detection of metastatic disease in individuals with pathologically confirmed pancreatic ductal adenocarcinoma. Following screening, using a standardized administration protocol and dose, participants will undergo \[¹⁸F\]FAPI-74 PET/CT screening. SOC procedures and interventions will be captured during 3 months +/-14 days post injection. The primary objective is to evaluate the sensitivity and specificity of such \[¹⁸F\]FAPI-74 PET/CT using a composite SOT panel. The maximum expected duration of the trial is approximately 24 months from first patient screening to last patient SOC follow up. The participants will be followed-up for safety for 24 to 72 hours after the dose of \[¹⁸F\]FAPI-74 PET/CT.

NCT Number	NCT07217717
Lead Sponsor	SOFIE
Conditions	Pancreatic Ductal Adenocarcinoma (PDAC)
Enrollment	200 participants
Start Date	2025-12-11
Primary Completion	2027-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-30