gastric cancer
Conditions
Brief summary
Proportion of patients who present an appropriate change of TNM classification, determined by initial staging following the addition of 68Ga-FAPI-46 PET-CT
Detailed description
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.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who present an appropriate change of TNM classification, determined by initial staging following the addition of 68Ga-FAPI-46 PET-CT | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |