Pancreatic Cancer Diagnosis With FAPI-PET Imaging

Turku University Hospital (TYKS)

Status and phase

Enrolling

Phase 3

Phase 2

Conditions

Diagnostics

Staging

Imaging, Diagnostic

FAPI

Oncologic Surgery

Positron Emission Tomography

Recurrent Pancreatic Cancer

Pancreatic Cancer

Treatments

Device: PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT07098598

Panca-FAPI

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.