"Diagnostic value of 68Ga-FAPI-46 PET/CT in the initial work-up of pancreatic and biliary cancers eligible to a curative treatment" "FAPDIG"

Conditions

Cholangiocarcinoma, Pancreatic adenocarcinoma

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 M status of the TNM, determined by standard staging, following the addition of 68Ga-FAPI-46 PET-CT to the reference examinations, 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, 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, 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

Related papers

No related papers found yet.

Interventions

DRUGGalliaPharm

DRUG0

DRUG74 à 1

DRUG85 GBq

DRUGgénérateur radiopharmaceutique

DRUGGalliad

DRUG68GA-FAPI-46

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

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 M status of the TNM, determined by standard staging, following the addition of 68Ga-FAPI-46 PET-CT to the reference examinations, 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, 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, Diagnostic parameters (Sensitivity, Specificity, positive (VPP) and negative (VPN) predictive values) o	—

Measure

Time frame

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, 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, 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, Diagnostic parameters (Sensitivity, Specificity, positive (VPP) and negative (VPN) predictive values) o

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Countries

France

Outcome results

None listed