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A Study of 68Ga-FAPI Breast PET/MRI Scans in People With Breast Cancer
A Prospective Study to Evaluate the Feasibility of 68Ga-FAPI Breast PET/MRI in Diagnosing a Breast Cancer Pathologic Complete Response Following Neoadjuvant Chemotherapy
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Age ≥ 18 * ECOG Performance Status of ≤ 2 * Ability to review and signed informed consent * Histologically confirmed, newly diagnosed invasive breast cancer * Lymph node metastases (either histologically confirmed or radiographic evidence of lymph node metastases). * Planned to undergo SOC NAC prior to surgical resection as outlined in section 4.1 Exclusion Criteria: * Pregnancy or lactation. * Patients who cannot undergo PET/MRI scanning because of: * devices or implants that are not MRI safe * hypersensitivity or known allergy to gadolinium-based contrast agents * physical fitness not allowing scanning in prone for 30 minutes * weight limits (450 lb. weight limit) * Severe kidney disfunction (estimated GFR \< 30 ml/min/1.73 m2) (CKD-EPI (2021)) * Imaging features suspicious for concomitant in-situ cancer (LCIS/DCIS), such as nonbiopsied groups of microcalcifications * Distant metastases (contraindication for NAC)
About the study
The purpose of this study is to find out whether it is practical (feasible) to use a new type of imaging scan called 68Ga-FAPI PET/MRI (positron emission tomography/magnetic resonance imaging) to evaluate how well breast cancer responds to neoadjuvant chemotherapy.
What is being tested
- 68Ga-FAPI-PET/MRI (diagnostic test)
Sponsor: Memorial Sloan Kettering Cancer Center · Participants: 10 · Started: Oct 20, 2026
Contact the study team
- Somali Gavane, MD · Phone: 212-639-2403
Official record on ClinicalTrials.gov — NCT07899892
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.