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Clinical Trial NCT07478523 (FAPDIG) for Cholangiocarcinoma, Pancreatic Adenocarcinoma is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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FAPI-PET Value for the Initial Screening of Pancreatic and Biliary Cancers (FAPDIG) Phase 2 120 High Unmet Need

Not yet recruiting
Clinical Trial NCT07478523 (FAPDIG) is designed to study Diagnostic for Cholangiocarcinoma, Pancreatic Adenocarcinoma. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on 16 March 2026 until the study accrues 120 participants. Led by University Hospital, Bordeaux, this study is expected to complete by 16 March 2029. The latest data from ClinicalTrials.gov was last updated on 17 March 2026.
Brief 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. Current standard of care for pancreatic cancer imaging at initial workup comprise CT imaging and MRI. However, these imaging m...Show More
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

Conditions
CholangiocarcinomaPancreatic Adenocarcinoma
Other Study IDs
  • FAPDIG
  • CHUBX 2022/39
NCT ID Number
NCT07478523
Start Date (Actual)
2026-03-16
Last Update Posted
2026-03-17
Completion Date (Estimated)
2029-03-16
Enrollment (Estimated)
120
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Primary Purpose
Diagnostic
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimental68Gallium-FAPI-46 Injection
TEP-TDM au 68Ga-FAPI-46
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
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Inclusion (Day 0)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
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
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.
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
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
Inclusion (Day 0)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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)

  • 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
University Hospital, Bordeaux logoUniversity Hospital, Bordeaux
Study Central Contact
Contact: Charles Mesguich, Dr., 05 57 65 63 35, [email protected]
1 Study Locations in 1 Countries
CHU de Bordeaux, Pessac, 33604, France
Charles Mesguich, Dr., Contact, 05 57 65 63 35, [email protected]