Breast cancer
Conditions
Brief summary
To measure the performance of 68Ga-FAPI-46 PET/CT imaging to predict complete histological response after neoadjuvant chemotherapy plus Pembrolizumab, in terms of Area under the ROC curve (AUC of the ROC curve)..
Detailed description
Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances for: - detection of metastases (using the total number of metastatic lesion), - Evaluation of the tumor burden (using the total FAP expression tumor volume/TFTV* and the total metabolic tumor volume/TMTV*, respectively)., Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT predictive performances, separately and combined (association of biomarkers extracted from 68Ga-FAPI-46 PET/CT imaging, 18F-FDG PET/CT imaging with response to treatment)., Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT prognostic performances, separately and combined (association of biomarkers extracted from 68Ga-FAPI-46 PET/CT imaging, 18F-FDG PET/CT imaging with recurrence and/or death from breast cancer)., Assessment of the predictive model performance combining 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT imaging data using sensitivity, specificity, positive and negative predictive values and area under curve the ROC curve(AUC of the ROC curve)., Exploratory: Correlation of 68Ga-FAPI-46 PET/CT imaging data with histological evaluation of CAF subpopulations (immunohistochemical staining for FAP), immune microenvironment (PD-L1 staining and TILs analysis) and comparison of the sensibility of 68Ga-FAPI-46 PET/CT imaging with that of histology., Exploratory: Quantitative analyze of circulating tumor DNA (ctDNA) before and after neoadjuvant treatment (pre-surgery), and correlation of them with biomarkers extracted from initial PET/CT scans (68Ga-FAPI-46 + 18F-FDG) on the one hand, and histological response on the other.
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGsolution à diluer pour perfusion
DRUG68Ga-FAPI-46
DRUGsolution pour perfusion
DRUGEpirubicin Eugia 2 mg/ml oplossing voor injectie
Sponsors
Institut Curie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To measure the performance of 68Ga-FAPI-46 PET/CT imaging to predict complete histological response after neoadjuvant chemotherapy plus Pembrolizumab, in terms of Area under the ROC curve (AUC of the ROC curve).. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances for: - detection of metastases (using the total number of metastatic lesion), - Evaluation of the tumor burden (using the total FAP expression tumor volume/TFTV* and the total metabolic tumor volume/TMTV*, respectively)., Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT predictive performances, separately and combined (association of biomarkers extracted from 68Ga-FAPI-46 PET/CT imaging, 18F-FDG PET/CT imaging with response to treatment)., Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT prognostic performances, separately and combined (association of biomarkers extracted from 68Ga-FAPI-46 PET/CT imaging, 18F-FDG PET/CT imaging with recurrence and/or death from breast cancer)., Assessment of the predictive model performance combining 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT imaging data using sensitivity, specificity, positive and negative predictive values and area under curve the ROC curve(AUC of the ROC curve). | — |
Countries
France
Outcome results
None listed