NCT07098598

Pancreatic Cancer Diagnosis With FAPI-PET Imaging

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Turku University Hospital · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Positron Emission Tomography
• Pancreatic Cancer
• FAPI
• Diagnostics
• Recurrent Pancreatic Cancer
• Oncologic Surgery
• Imaging, Diagnostic
• Staging

Interventions

Type	Name	Description
DEVICE	PET/CT	PET/CT with FAPI-74 tracer is performed.

Timeline

• Start date: 2024-10-09
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2025-08-01
• Last updated: 2025-08-01

Locations

1 site across 1 country: Finland