Diagnostics, FAPI, Imaging, Diagnostic, Oncologic Surgery, Pancreatic Cancer, Positron Emission Tomography, Recurrent Pancreatic Cancer, Staging
Conditions
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.
Interventions
DEVICEPET/CT
PET/CT with FAPI-74 tracer is performed.
Sponsors
Turku University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Finland
Contacts
Primary ContactSaila Kauhanen, docent
Outcome results
None listed