ProspectivE phase 0 pilot study, assessing potential prognostic and theranostic interest of 68Ga-PentiXafor PET-CT In metastatic triple neGative brEast caNCer patiEnts (EXIGENCE)

triple-negative breast cancer

Concordance study of metastatic uptake seen in [18F]FDG PET/CT scan and [68Ga]Ga-PentixaFor PET/CT scan per "lesion" by comparing for each lesion the [18F]FDG PET scan and [68Ga]Ga-PentixaFor PET/CT scan by assessing a ratio "Number of positive or negative [68Ga]Ga-PentixaFor lesions / Number of positive or negative FDG lesions” performed at patient inclusion.

Concordance study of metastatic uptake seen in [18F]FDG PET/CT scan and [68Ga]Ga-PentixaFor PET/CT scan per "lesion" by comparing for each lesion the [18F]FDG PET/CT scan and [68Ga]Ga-PentixaFor PET/CT scan by assessing a ratio "Number of positive or negative [68Ga]Ga-PentixaFor lesions / Number of positive or negative FDG lesions” performed at disease progression., Conventional imaging (CT scan), and [68Ga]Ga-PentixaFor PET/CT will be analysed for each lesion, obtaining a ratio of number of [68Ga]Ga-PentixaFor(+) lesions / number of CT scan lesions" at patient inclusion., Conventional imaging: CT scan, and [68Ga]Ga-PentixaFor PET/CT will be analysed for each lesion, obtaining a ratio of number of [68Ga]Ga-PentixaFor(+) lesions / number of CT scan lesions" at disease progression., Percentage of [68Ga]Ga-PentixaFor(+) metastatic tumor burden compared to total metastatic tumor burden by [18F]FDG PET/CT ., Assess the correlation between the standard uptake values (SUV) of [68Ga]Ga-PentixaFor and IHC CXCR4 expression, by comparing the [68Ga]Ga-PentixaFor semi-quantitative data with the CXCR4 expression results of biopsied metastases at screening and at disease progression if biopsy is performed., The tolerance of [68Ga]Ga-PentixaFor will be checked by measuring and monitoring vital signs for 60 minutes after [68Ga]Ga-PentixaFor administration. The patient will be informed that in the event of abnormal physical signs, occurring within 48 hours after [68Ga]Ga-PentixaFor administration, he (she) must inform the investigator for registration. The CTC-NCI Common Toxicity Criteria, version 5.0 reference will be used.

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