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NCT Number: NCT07098598

Pancreatic Cancer Diagnosis With FAPI-PET Imaging

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.

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Key information

Conditions

Positron Emission Tomography Diagnostics Digestive System Diseases Digestive System Neoplasms Disease Endocrine Gland Neoplasms Endocrine System Diseases FAPI Imaging, Diagnostic Neoplasms Neoplasms by Site Oncologic Surgery Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrent Pancreatic Cancer Staging

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Turku PET Centre, Turku University Hospital

Turku, Finland

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PET/CT

Device

PET/CT with FAPI-74 tracer is performed.

Primary outcomes

  1. 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

    Time frame: 2 years

  2. 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

    Time frame: 2 years

  3. 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

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Saila Kauhanen, docent

CONTACT

[email protected]

+358503017010

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2025
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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