(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 Gastric cancer|Gastric adenocarcinoma|Signet-ring cell adenocarcinoma

Inclusion criteria

• {"criterion_text":"- Gastric cancer: stage ≥ II gastric adenocarcinoma or signet-ring cell adenocarcinoma whatever the stage, potentially requiring curative treatment\n- Age > 18 years old at time of signed consent\n- Beneficiary of social security insurance\n- Signed informed consent by the participant and the investigator"}

Exclusion criteria

• {"criterion_text":"- Tumor M+ or with suspicion of distant metastasis on standard assessment\n- Person deprived of liberty by judicial or administrative decision\n- Neoadjuvant treatment already started\n- History of other active cancer\n- Known contraindication to a PET examination with injection of radiopharmaceuticals (hypersensitivity to the radiopharmaceutical drug and/or excipients)\n- Pregnant or breastfeeding woman\n- Woman of childbearing capacity and not benefiting from effective contraception (HAS criterion)\n- Person subject to a legal protection measure or unable to personally give consent\n- Person in an emergency situation\n- Exclusion period from another protocol"}

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":"Estimate the proportion of patients in the target population for whom TNM classification is appropriately changed after addition of 68Ga-FAPI-46 PET-CT to the reference examinations during initial staging (including laparoscopy); i.e. compare TNM determined by standard staging (including laparoscopy) versus after PET-CT to determine proportion with appropriate change."}

Secondary endpoints

• {"endpoint_text":"- Proportion of patients who present an appropriate change of the N and/or M status of the TNM, determined by standard thoraco-abdominopelvic CT imaging alone, following the addition of 68Ga-FAPI-46 PET-CT","definition_or_measurement_approach":"Proportion of patients for whom N and/or M status determined by standard TAP CT alone is modified appropriately after 68Ga-FAPI-46 PET-CT (comparison of CT-alone staging vs CT+PET-CT)."}
• {"endpoint_text":"- Proportion of patients who present an appropriate change of the M status of the TNM, determined by standard thoraco-abdominopelvic CT imaging alone, following the addition of 68Ga-FAPI-46 PET-CT","definition_or_measurement_approach":"Proportion of patients with a modification of M status (metastatic status) when comparing standard TAP CT alone versus 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, surgical resection complementary, palliative treatment by chemotherapy or other systemic treatment following the addition of 68Ga-FAPI-46 PET-CT","definition_or_measurement_approach":"Proportion of patients for whom therapeutic management is appropriately added or removed (listed management elements) after PET-CT compared to 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":"Mean difference (or average counts) in number of tumor lesions (nodal or distant) detected by PET-CT versus reference staging examinations."}
• {"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 reproducibility measured by Cohen's kappa between coordinating center and investigating center observers for PET/CT interpretation."}

France

Earliest CTIS Part Ii Submission Date

14-04-2026

Latest Decision Or Authorization Date

30-04-2026

Processing Time Days

16

Number Of Sites

2

Number Of Participants

40

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Bordeaux

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France