68Ga‑FAPI‑46 PET/CT to improve initial staging for pancreatic and bile duct cancer
Diagnostic Value of 68Ga-FAPI-46 PET/CT in the Initial Work-up of Pancreatic and Biliary Cancers Eligible to a Curative Treatment
This will try 68Ga‑FAPI‑46 PET/CT scans in people newly diagnosed with pancreatic or bile duct cancer to see if they find hidden spread that CT or MRI miss.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Pessac) |
| Trial ID | NCT07478523 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional imaging study at CHU de Bordeaux adds 68Ga‑FAPI‑46 PET/CT to the standard initial workup for people with newly diagnosed or strongly suspected pancreatic adenocarcinoma or cholangiocarcinoma who appear non‑metastatic and are candidates for curative treatment. Participants undergo the FAPI PET/CT (TEP‑TDM au 68Ga‑FAPI‑46) in addition to routine CT and/or MRI staging. The main aim is to determine whether FAPI PET detects occult visceral or lymph node metastases missed by standard imaging and whether that finding would change treatment plans, including surgical decisions. Patients with known or suspected distant metastases on standard staging are excluded.
Who should consider this trial
Good fit: Adults (≥18) with newly diagnosed or strongly suspected pancreatic adenocarcinoma or cholangiocarcinoma who have no evidence of distant metastasis (M0) and are being considered for curative treatment, able to give informed consent.
Not a fit: Patients with known or suspected distant metastases (M+) or those not eligible for curative treatment are excluded and unlikely to benefit from this imaging approach.
Why it matters
Potential benefit: If successful, the scan could reveal hidden metastases before surgery so doctors can avoid ineffective operations and choose more appropriate treatments.
How similar studies have performed: Early, small studies of FAPI‑based PET tracers have shown promising tumor detection in pancreatic and other cancers, but prospective evidence specifically for initial staging of pancreatic and biliary cancers is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Population 1: De novo pancreatic adenocarcinoma (pathological evidence) or strong suspicion of de novo pancreatic adenocarcinoma on imaging, immediately resectable, borderline or locally advanced, potentially requiring curative treatment and non-metastatic (M0), according to reference staging. - Population 2: De novo cholangiocarcinoma eligible for curative treatment (pathological evidence) or strong suspicion of de novo pancreatic adenocarcinoma on imaging, non-metastatic (M0), according to reference extension assessment. according to reference extension report Criteria common to both populations: * Age \>18 years at the time of signing the informed consent * Patient affiliated to a social security system * Free and informed consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research) Exclusion Criteria: * Tumor M+ or with suspicion of distant metastasis on standard staging. * Neoadjuvant treatment * History of other active cancer * Pregnant or breastfeeding woman * Person under legal protection (guardianship or curatorship) * Person unable to personally give consent * Person in an emergency situation * Exclusion period from another protocol * Person deprived of liberty by judicial or administrative decision
Where this trial is running
Pessac
- CHU de Bordeaux — Pessac, France (Recruiting)
Study contacts
- Principal investigator: Charles Mesguich, Dr. — University Hospital, Bordeaux
- Study coordinator: Charles Mesguich, Dr.
- Email: charles.mesguich@chu-bordeaux.fr
- Phone: 05 57 65 63 35
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.