68Ga-FAPI-46 PET/CT imaging: The 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.
Study summary
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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Female with age ≥ 18 years,
2. 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,
3. Patients with measurable targets according to RECIST/PERCIST criteria,
4. Patients without distant metastasis based on staging 18F-FDG PET/CT,
5. Patients with tumor tissue available,
6. Patients who provided a signed written informed consent,
7. Patient ability to comply with protocol requirements,
8. Patients covered by a health insurance system.
Exclusion Criteria:
1. Pregnant and lactating women,
2. Patients with prior anti-PD(L)1 immunotherapy,
3. Patients with any contra-indication to chemo-immunotherapy standard of care therapy, per investigator assessment,
4. Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent,
5. Patients who have difficulty undergoing trial procedures for geographic, social or psychological reasons,
6. Person deprived of liberty or under guardianship
Primary outcome measure(s)
Area under the ROC curve — 6 months 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).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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