68Ga‑FAPI‑46 PET/CT to improve initial staging for pancreatic and bile duct cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.