FAPI-PET/CT imaging for diagnosing and staging pancreatic cancer
Diagnostic Efficacy of 18F-FAPI-74 PET/CT in Patients With Pancreatic Cancer
This study will try 18F‑FAPI‑74 PET/CT scans in adults with suspected or recurrent pancreatic cancer to see if they detect lymph node spread and distant metastases more accurately.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Turku University Hospital Government |
| Locations | 1 site (Turku) |
| Trial ID | NCT07098598 on ClinicalTrials.gov |
What this trial studies
This prospective Phase 2/3 diagnostic study will image adults with suspected primary or recurrent pancreatic cancer using the 18F‑FAPI‑74 PET/CT tracer. Participants undergo whole‑body PET/CT at the Turku PET Centre and the FAPI findings will be compared against conventional imaging (triphasic CT and, when available, 18F‑FDG PET/CT) and clinical or pathological reference standards. The main aims are to determine patient‑level sensitivity and specificity for detecting local lymph node metastasis and distant metastasis in initial staging and suspected recurrence. Eligible patients are aged 18–85 with WHO performance status 0–2 and must be able to provide informed consent.
Who should consider this trial
Good fit: Adults aged 18–85 with suspected primary or recurrent pancreatic cancer, WHO performance status 0–2, who can give informed consent are the intended participants.
Not a fit: Patients who cannot undergo whole‑body PET/CT, are pregnant or breastfeeding, are minors, or have medical conditions that prohibit PET/CT are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, FAPI‑PET/CT could improve detection of local lymph node and distant metastases, leading to more accurate staging and better treatment planning.
How similar studies have performed: Early small studies of FAPI PET in various cancers, including pancreatic cancer, have shown higher lesion uptake and promise for detecting lesions missed by FDG, but large prospective data are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Turku
- Turku PET Centre, Turku University Hospital — Turku, Finland (Recruiting)
Study contacts
- Principal investigator: Saila Kauhanen, docent — University of Turku and Turku University Hospital
- Study coordinator: Saila Kauhanen, docent
- Email: saila.kauhanen@utu.fi
- Phone: +358503017010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.