Pancreatic Cancer Diagnosis With FAPI-PET Imaging

NCT07098598 | Recruiting Phase 2 DMC

• 1 other identifier: Panca-FAPI
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Study Arms (1)

Staging

EXPERIMENTAL

Device: PET/CT

Interventions

PET/CT DEVICE

PET/CT with FAPI-74 tracer is performed.

Staging

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku PET Centre, Turku University Hospital

Turku, Finland

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Disease

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Saila Kauhanen, docent

  University of Turku and Turku University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saila Kauhanen, docent

CONTACT

+358503017010; saila.kauhanen@utu.fi

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: August 1, 2025
• Study Start: October 9, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)