[68]GA-FAPI-46 PET/CT for the diagnosis of metastatic lesions in patients with lobular breast cancer (ICL). FAPICL

Condition studied

invasive lobular carcinomas of the breast

Investigational medicinal product(s)

Every trial of [68Ga]Ga-FAPI-46 across our registers →

Eligibility

Primary endpoint

Percentage of patients for whom at least one secondary lesion is detected with [68]Ga-FAPI and confirmed by histology, when the [18]F-FDG PET/CT is negative.

Endpoint detail

Average number per patient of lesions detected with [68]Ga-FAPI, not seen on [18F]-FDG. This criterion will be collected at the time of the imaging review by a nuclear medicine physician., Number of positive lesions in histology, among the lesions visualized in PET/CT with [68]Ga-FAPI (and in case of negative histology, identify the differential diagnoses). This criterion will be collected at the time of publication of the histological report of the detected suspicious lesion., This criterion will be collected and compared at the time of the publication of the histological report of the detected suspicious lesion and between the 2 PET scans., The values of SUVmax lesion, SUVmax liver, SUVmax aorta will be collected at the time of the imaging interpretation by a nuclear medicine physician, for each suspicious lesion., Estimate the number of lesions detected by PET/CT with [68]Ga-FAPI and not detected by PET/CT with [18]F-FES in our study population., Estimate the number of lesions detected on PET/CT with [18]F-FES and not detected on PET/CT with [68]Ga-FAPI in our study population