Pancreatic Cancer Research

Clinical trialPhase 2 / Phase 3Recruiting

Pancreatic Cancer Diagnosis With FAPI-PET Imaging

Diagnostic Efficacy of 18F-FAPI-74 PET/CT in Patients With Pancreatic Cancer

Outcome
Ongoing
Phase
Phase 2 / Phase 3
Status
Recruiting
Study type
Interventional
Start
9 October 2024
Listed end
October 2026
Enrollment
100 participants
Sites
1
Primary outcomes
1) To assess the sensitivity and specificity of 18F-FAPI-74 PET/CT in detection of local lymph node metastasis in patient level in patients with primary pancreatic cancer; 2) To assess the sensitivity and specificity 18F-FAPI-74 PET/CT in detection of distant metastasis in patient level in patients with primary pancreatic cancer; 3) To assess the sensitivity and specificity of 18F-FAPI-74 PET/CT in detection of local lymph node metastasis and distant metastasis in patient level in patients with recurrent pancreatic cancer
Sponsor type
Other government
Results posted
No
Last update
1 August 2025

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Brief summary public domain (ClinicalTrials.gov)

Staging pancreatic cancer (PC) presents a clinical challenge. Triphasic whole body CT is the primary imaging method in diagnosing, staging and during follow up. Conventional PET/CT with 18F-labelled fluorodeoxyglucose (18F-FDG) has its limitations and therefore has a secondary role in imaging pancreatic cancer patients. These conventional imaging methods are good in detecting primary tumors and distant metastasis but poor in detecting local lymph node metastasis. A new PET tracer, fibroblast activation protein inhibitor (FAPI), targets FAP, a protein overexpressed in cancer-associated fibroblasts. It presents a potential new PET imagining tool. The objective of this prospective diagnostic study is to evaluate the diagnostic efficacy of 18F-FAPI-74 PET/CT in patients with PC. The aim is to evaluate the sensitivity and specificity of 18F-FAPI-74 in detection of local lymph node metastasis and distant metastasis in patient level in patients with PC in primary staging and when suspected recurrence. 100 patients with PC are enrolled on whom PET/CT studies are performed with the novel 18F-FAPI-74 tracer. The data will be collected between 2024-2026.