"Contribution of 68Ga-FAPI-46 PET-CT in the initial staging of gastric cancers eligible for curative treatment" "FAPGASTRO"

Condition studied

gastric cancer

Investigational medicinal product(s)

Eligibility

Primary endpoint

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

Endpoint detail

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, 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, 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, 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, Cohen's kappa coefficient measuring the inter-observer reliability of 68Ga-FAPI-46 PET/CT interpretation between coordinating center and investigating center observers.