Prospective multicenter study evaluating the prediction of histological response after neoadjuvant pembrolizumab in combination with chemotherapy by pre-treatment 68Ga-FAPI-46 PET/CT imaging in patients with early-stage high-risk TNBC.
Female with age ≥ 18 years,
Patients with previously untreated, non-metastatic, centrally confirmed TNBC for whom a neoadjuvant treatment with chemotherapy + pembrolizumab is the recommended option as standard of care,
Patients with measurable targets according to RECIST/PERCIST criteria,
Patients without distant metastasis based on staging 18F-FDG PET/CT,
Pregnant and lactating women,
Patients with prior anti-PD(L)1 immunotherapy,
Patients with any contra-indication to chemo-immunotherapy standard of care therapy, per investigator assessment,
Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent,
Single group
68Ga-FAPI-46 PET/CT imaging
Procedure/SurgeryThe 68Ga-FAPI-46 PET/CT scan will be performed for each patient pre-therapy and on the same machine as the 18F-FDG PET/CT scan and within 14 days before the start of treatment.
Area under the ROC curve
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).
Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances
Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances by detecting metastases
Evaluation of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances
Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT performances by evaluating the tumor burden (TFTV : total FAP expression tumor volume and TMTV : total metabolic tumor volume).
Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT predictive performances
Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT predictive performances, separately and combined at the end of neoadjuvant treatment cycles.
Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT pronostic performances
Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT pronostic performances, separately and combined at the end of the follow-up
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