Pancreatic Cancer Diagnosis With FAPI-PET Imaging

Not Applicable

Recruiting

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

• Registration Number: NCT07098598
• Lead Sponsor: Turku University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-09
• Status Verified: 2025-05
• Study First Submitted: 2025-05-27
• Study First Submitted QC: 2025-07-31
• Last Update Submitted: 2025-07-31
• Study First Posted: 2025-08-01
• Last Update Posted: 2025-08-01
• Primary Completion: 2026-10
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Suspected primary or recurrent pancreatic cancer
• Subjects must be male or female aged 18-85 years.
• WHO performance score 0-2.
• Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol.

Exclusion Criteria

• Vulnerable study subjects such as described in Finnish law clinical studies (disabled, children, pregnant or breast-feeding women, prisoners) will not be included.
• Study subject is not able to understand the purpose of the study.
• Medical conditions prohibiting whole-body PET/CT imaging.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	2 years
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 years
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	2 years

Trial Locations

Locations (1)

Turku PET Centre, Turku University Hospital; 🇫🇮 Turku, Finland