(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-CYANO-4,4-DIFLUOROPYRROLIDIN-1-YL)-2-OXOETHYLCARBAMOYL)-QUINOLIN-6-YL)(METHYL)AMINO)-PROPYL)PIPERAZIN-1-YL)-2-OXOETHYL)-68GA-[1,4,7,10]-TETRAAZACYCLODODECANE-1,4,7-TRIYL)TRIACETATE for Cholangiocarcinoma | Pancreatic adenocarcinoma

Inclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Age >18 years at the time of signing the informed consent"}
• {"criterion_text":"- Patient affiliated to a social security system"}
• {"criterion_text":"- 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

• {"criterion_text":"- Tumor M+ or with suspicion of distant metastasis on standard staging"}
• {"criterion_text":"- Person deprived of liberty by judicial or administrative decision"}
• {"criterion_text":"- Person in an emergency situation"}
• {"criterion_text":"- Exclusion period from another protocol"}
• {"criterion_text":"- Neoadjuvant treatment"}
• {"criterion_text":"- History of other active cancer"}
• {"criterion_text":"- Pregnant or breastfeeding woman"}
• {"criterion_text":"- Person under legal protection (guardianship or curatorship)"}
• {"criterion_text":"- Person unable to personally give consent"}

Primary endpoints

• {"endpoint_text":"- Proportion of patients who present an appropriate change of TNM classification determined by initial staging, following the addition of 68Ga-FAPI-46 PET-CT","definition_or_measurement_approach":"Measured as the proportion of included patients for whom the N and/or M status of the TNM, as determined by standard reference staging, is modified after performing 68Ga-FAPI-46 PET-CT (i.e. change of TNM classification following addition of 68Ga-FAPI-46 PET-CT to reference examinations)."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Measured as the proportion of patients in whom the M status (presence/absence of distant metastasis) determined by standard staging is changed after addition of 68Ga-FAPI-46 PET-CT."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Measured as the proportion of patients for whom 68Ga-FAPI-46 PET-CT leads to addition or removal of specified therapeutic management elements compared with reference examinations."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured as the mean number of lesions (local, nodal, distant) detected by 68Ga-FAPI-46 PET-CT versus those detected by standard reference staging."}
• {"endpoint_text":"- Cohen's kappa coefficient measuring the inter-observer reliability of 68Ga-FAPI-46 PET/CT interpretation between coordinating center and investigating center observers","definition_or_measurement_approach":"Inter-observer agreement measured using Cohen's kappa between coordinating center and investigating center readers of 68Ga-FAPI-46 PET/CT."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Diagnostic performance metrics (sensitivity, specificity, positive predictive value, negative predictive value) of 68Ga-FAPI-46 PET-CT for detecting loco-regional nodal and distant metastatic disease, compared to reference standard."}

France

Earliest CTIS Part Ii Submission Date

06-06-2025

Latest Decision Or Authorization Date

30-07-2025

Processing Time Days

54

Number Of Sites

3

Number Of Participants

120

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Bordeaux

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France