FAPI-PET value for the initial screening of pancreatic and biliary cancers (FAPDIG Study)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Bordeaux

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

5 Mar 2026 → ongoing

Decision date (initial)

2025-07-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Ministry of Health (PHRC Inter Régional 2021)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

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

Secondary objectives 5

1. To estimate the proportion of patients who present an appropriate change of the M status of the TNM 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.
2. To estimate the proportion of patients who present an appropriate change of therapeutic management following the addition of 68Ga-FAPI-46 PET-CT to the reference examinations.
3. To estimate the number of additional tumor lesions detected by 68Ga-FAPI-46 PET-CT addition to reference examinations
4. To estimate inter-observer reproducibility of 68Ga-FAPI-46 PET-CT interpretation
5. To estimate diagnostic performance of 68Ga-FAPI-46 PET-CT for baseline staging (sensitivity, specificity, positive and negative predictive values)

Conditions and MedDRA coding

Cholangiocarcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 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.
2. 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.
3. Age >18 years at the time of signing the informed consent
4. Patient affiliated to a social security system
5. 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 9

1. Tumor M+ or with suspicion of distant metastasis on standard staging
2. Person deprived of liberty by judicial or administrative decision
3. Person in an emergency situation
4. Exclusion period from another protocol
5. Neoadjuvant treatment
6. History of other active cancer
7. Pregnant or breastfeeding woman
8. Person under legal protection (guardianship or curatorship)
9. Person unable to personally give consent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients who present an appropriate change of TNM classification determined by initial staging, following the addition of 68Ga-FAPI-46 PET-CT

Secondary endpoints 5

1. Proportion of patients who present an appropriate change of the M status of the TNM, determined by standard staging, following the addition of 68Ga-FAPI-46 PET-CT to the reference examinations
2. Proportion of patients who present an appropriate addition or removal of one of the following elements of therapeutic management : curative surgical treatment, neoadjuvant or adjuvant treatment by chemotherapy or radiotherapy, complementary surgical resection, palliative treatment by chemotherapy or other systemic treatment, following the addition of 68Ga-FAPI-46 PET-CT
3. Average number of tumor lesions, lymph node or distant, detected by 68Ga-FAPI-46 PET-CT compared to the number of tumor lesions detected by reference staging.
4. Cohen's kappa coefficient measuring the inter-observer reliability of 68Ga-FAPI-46 PET/CT interpretation between coordinating center and investigating center observers
5. Diagnostic parameters (Sensitivity, Specificity, positive (VPP) and negative (VPN) predictive values) of 68Ga-FAPI-46 PET-CT for detection of loco-regional lymph node and distant metastatic lesions

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Bordeaux

Sponsor organisation

Centre Hospitalier Universitaire De Bordeaux

Address

12 Rue Dubernat

City

Talence

Postcode

33400

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Bordeaux

Contact name

Dr Charles MESGUICH

Public contact point

Organisation

Centre Hospitalier Universitaire De Bordeaux

Contact name

Dr Charles MESGUICH

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications