2024-517270-23-00RecruitingPhase 2
FAPI-PET value for the initial screening of pancreatic and biliary cancers (FAPDIG Study)
"Diagnostic value of 68Ga-FAPI-46 PET/CT in the initial work-up of pancreatic and biliary cancers eligible to a curative treatment" "FAPDIG"
Source: EU CTIS (euclinicaltrials.eu) · Last updated 14 Aug 2026
Brief summary (registry, in English)
To estimate the proportion of patients who present an appropriate change of TNM classification following the addition of 68Ga-FAPI-46 PET-CT to the reference examinations, during the initial staging of pancreatic and bile duct cancers eligible for curative treatment. Each type of cancer will be studied (analyzed) separately
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 22 Apr 2025
- Start date
- 5 Mar 2026
- Lead sponsor
- Centre Hospitalier Universitaire De Bordeaux
- EU CT number
- 2024-517270-23-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly found pancreatic cancer or bile duct cancer that has not spread and can be treated with the aim of removing all of the disease.
- Age
- Older than 18 years
- Sex
- All sexes
- Disease stage
- Newly diagnosed pancreatic adenocarcinoma (proven, or strongly suspected on imaging) that can be removed by surgery or is borderline or locally advanced; or newly diagnosed cholangiocarcinoma (proven, or strongly suspected on imaging). The cancer must be able to have treatment meant to remove all of the disease and must not have spread (M0) on the standard staging.
- Earlier treatment
- No neoadjuvant treatment (treatment given before the main treatment).
Main reasons for not taking part
- Cancer that has spread (M+) or is suspected to have spread to distant sites
- Another active cancer in the past
- Neoadjuvant treatment
- Pregnant or breastfeeding women
- Cannot personally give consent, or is under legal protection (guardianship or curatorship)
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of other active cancer
Other
- Tumor M+ or with suspicion of distant metastasis on standard staging
- Person deprived of liberty by judicial or administrative decision
- Person in an emergency situation
- Exclusion period from another protocol
- Neoadjuvant treatment
- Pregnant or breastfeeding woman
- Person under legal protection (guardianship or curatorship)
- Person unable to personally give consent
Who the study is looking for
- 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 (pathological evidence) or strong suspicion of de novo cholangiocarcinoma on imaging - Eligible for curative treatment and non-metastatic (M0), according to according to reference staging.
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Leon Berard | Lyon | France | Recruiting |
| Institut Regional Du Cancer De Montpellier | Montpellier Cedex 5 | France | Recruiting |
| Centre Hospitalier Universitaire De Bordeaux | Talence | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.