CholangiocarcinomaPhase 2FAPDIGNCT07478523
FAPI-PET Value for the Initial Screening of Pancreatic and Biliary Cancers
A Phase 2 study testing TEP-TDM au 68Ga-FAPI-46 in people with Cholangiocarcinoma and Pancreatic Adenocarcinoma, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Pancreatic cancer is one of the worst-prognosed cancers with a 5-year survival rate of less than 10%. Its incidence has been steadily increasing for several years in France and worldwide. Pancreatic adenocarcinoma may become the second leading cause of cancer mortality in the years 2030-2040. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma, Pancreatic Adenocarcinoma
- What is being tested?
- TEP-TDM au 68Ga-FAPI-46
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 21 Apr 2026to 21 Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
- Person deprived of liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux
Pessac, 33604
Charles Mesguich, Dr., 05 57 65 63 35, charles.mesguich@chu-bordeaux.fr
About this study
Official title: Diagnostic Value of 68Ga-FAPI-46 PET/CT in the Initial Work-up of Pancreatic and Biliary Cancers Eligible to a Curative Treatment
Pancreatic cancer is one of the worst-prognosed cancers with a 5-year survival rate of less than 10%. Its incidence has been steadily increasing for several years in France and worldwide. Pancreatic adenocarcinoma may become the second leading cause of cancer mortality in the years 2030-2040. Current standard of care for pancreatic cancer imaging at initial workup comprise CT imaging and MRI. However, these imaging modalities lack sensitivity and accuracy, with an estimated rate of about 30% of patients either with visceral or lymph node metastasis discovered during planned surgery or with relapse occurring during the first 6 months after surgery suggesting occult metastasis at diagnosis. Therefore, there is a clear need for new imaging modalities at initial diagnosis for more adapted and individualized therapeutic decision.
Cholangiocarcinoma (or cancer of the bile ducts) also has a dismal prognosis with a 5-year survival rate of 7%. The therapeutic objective is to obtain a surgical resection R0 when possible which can be associated with improved survival of up to 40% in appropriately selected patients. However, surgical morbidity and mortality are high, especially in peri-hilar forms. The detection of lymph node metastasis beyond the hepatic hilum is crucial, as surgery is considered futile in this situation. Current standard imaging at initial work-up include CT and MRI that have limited performance in estimating surgical resecability with a sensitivity of 60% for detecting lymph nodes metastasis and 67% for detecting distant metastasis. Therefore, there is also here an unmet need for improved baseline imaging.
Read more
In summary, this project is focused on two digestive cancers with poor prognosis in which preoperative imaging accuracy remains today imperfect.
Therefore, we aim to demonstrate, when compared with current standard imaging, that 68Ga-FAPI-46 PET/CT performed at baseline imaging in pancreatic and biliary duct cancers, leads to a change in TNM classification and subsequently to a change in therapeutic management.
To our knowledge, this will be the first (or one of the first) structured multicenter prospective study to evaluate the additional and potentially decisive contribution of 68Ga-FAPI-46 PET/CT carried out after a standard imaging workup at initial diagnosis of pancreatic and biliary duct cancers.
If the diagnostic superiority of 68Ga-FAPI-46 PET/CT is confirmed, this study could lead to define a new standard of care for the imaging of these cancers with poor prognosis. The study should also help to set the ground for future theranostic approaches where 68Ga-FAPI-46 PET/CT would help select patients for targeted radionuclide therapy.
- Conditions
- Cholangiocarcinoma, Pancreatic Adenocarcinoma
- Being tested
- TEP-TDM au 68Ga-FAPI-46
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEP-TDM au 68Ga-FAPI-46Drug
PET-CT examination with 68Ga-FAPI-46 in the nuclear medicine department. 68Ga-FAPI-46 is administered intravenously at a mean activity of 2 MBq/kg
| Study group | Role | What they receive |
|---|---|---|
| 68Gallium-FAPI-46 Injection | Experimental | Not described Receives: Drug: TEP-TDM au 68Ga-FAPI-46 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion
Proportion of patients who present an appropriate change of TNM classification determined by initial staging, following the addition of 68Ga-FAPI-46 PET-CT
Measured: Inclusion (Day 0)
Secondary outcomes (5)
Proportion of appropriate change of the M status of the TNM
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
Measured: Inclusion (Day 0)
Proportion of appropriate addition or removal of therapeutic management
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
Measured: Inclusion (Day 0)
Average number of tumor lesions, lymph node or distant
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.
Measured: Inclusion (Day 0)
Cohen's kappa coefficient
Cohen's kappa coefficient measuring the inter-observer reliability of 68Ga-FAPI-46 PET/CT interpretation between coordinating center and investigating center observers
Measured: Inclusion (Day 0)
Predictive values
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
Measured: Inclusion (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start21 Apr 2026
- Primary completion21 Mar 2028 (estimated)
- Study completion21 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Mesguich, Dr., Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478523
- Sponsor's protocol ID
- CHUBX 2022/39
- Acronym
- FAPDIG
- Status last verified
- Apr 2026
- First submitted
- 12 Mar 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of 68Ga-FAPI-46 PET/CT in the Initial Work-up of Pancreatic and Biliary Cancers Eligible to a Curative Treatment
- ClinicalTrials.gov ID
- NCT07478523
- Acronym / sponsor ID
- FAPDIG / CHUBX 2022/39
- Conditions
- Cholangiocarcinoma, Pancreatic Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 21 Mar 2028 (estimated)
- Study completion
- 21 Mar 2029 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pancreatic cancer is one of the worst-prognosed cancers with a 5-year survival rate of less than 10%. Its incidence has been steadily increasing for several years in France and worldwide. Pancreatic adenocarcinoma may become the second leading cause of cancer mortality in the years 2030-2040. Current standard of care for pancreatic cancer imaging at initial workup comprise CT imaging and MRI. However, these imaging modalities lack sensitivity and accuracy, with an estimated rate of about 30% of patients either with visceral or lymph node metastasis discovered during planned surgery or with relapse occurring during the first 6 months after surgery suggesting occult metastasis at diagnosis. Therefore, there is a clear need for new imaging modalities at initial diagnosis for more adapted and individualized therapeutic decision.
Cholangiocarcinoma (or cancer of the bile ducts) also has a dismal prognosis with a 5-year survival rate of 7%. The therapeutic objective is to obtain a surgical resection R0 when possible which can be associated with improved survival of up to 40% in appropriately selected patients. However, surgical morbidity and mortality are high, especially in peri-hilar forms. The detection of lymph node metastasis beyond the hepatic hilum is crucial, as surgery is considered futile in this situation. Current standard imaging at initial work-up include CT and MRI that have limited performance in estimating surgical resecability with a sensitivity of 60% for detecting lymph nodes metastasis and 67% for detecting distant metastasis. Therefore, there is also here an unmet need for improved baseline imaging.
In summary, this project is focused on two digestive cancers with poor prognosis in which preoperative imaging accuracy remains today imperfect.
Therefore, we aim to demonstrate, when compared with current standard imaging, that 68Ga-FAPI-46 PET/CT performed at baseline imaging in pancreatic and biliary duct cancers, leads to a change in TNM classification and subsequently to a change in therapeutic management.
To our knowledge, this will be the first (or one of the first) structured multicenter prospective study to evaluate the additional and potentially decisive contribution of 68Ga-FAPI-46 PET/CT carried out after a standard imaging workup at initial diagnosis of pancreatic and biliary duct cancers.
If the diagnostic superiority of 68Ga-FAPI-46 PET/CT is confirmed, this study could lead to define a new standard of care for the imaging of these cancers with poor prognosis. The study should also help to set the ground for future theranostic approaches where 68Ga-FAPI-46 PET/CT would help select patients for targeted radionuclide therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Gallium-FAPI-46 Injection | Experimental | Drug: TEP-TDM au 68Ga-FAPI-46 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEP-TDM au 68Ga-FAPI-46PET-CT examination with 68Ga-FAPI-46 in the nuclear medicine department. 68Ga-FAPI-46 is administered intravenously at a mean activity of 2 MBq/kg | Drug | 68Gallium-FAPI-46 Injection |
Primary outcome
Proportion
Time frame: Inclusion (Day 0)
Proportion of patients who present an appropriate change of TNM classification determined by initial staging, following the addition of 68Ga-FAPI-46 PET-CT
5 secondary outcomes
Proportion of appropriate change of the M status of the TNM
Time frame: Inclusion (Day 0)
Proportion of appropriate addition or removal of therapeutic management
Time frame: Inclusion (Day 0)
Average number of tumor lesions, lymph node or distant
Time frame: Inclusion (Day 0)
Cohen's kappa coefficient
Time frame: Inclusion (Day 0)
Predictive values
Time frame: Inclusion (Day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles Mesguich, Dr. principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TEP-TDM au 68Ga-FAPI-46 in people with Cholangiocarcinoma and Pancreatic Adenocarcinoma, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles Mesguich, Dr. (05 57 65 63 35, charles.mesguich@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion (time frame: Inclusion (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.