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A Study of 68Ga-FAPI Breast PET/MRI Scans in People With Breast Cancer

RecruitingPhase 1

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

Sponsor: Memorial Sloan Kettering Cancer Center · Participants: 10 · Started: Oct 20, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07899892

Locations in the U.S.

New JerseyMemorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge
Memorial Sloan Kettering Monmouth (Limited protocol activities), Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale
New YorkMemorial Sloan Kettering Suffolk-Commack (Limited Protocol Activity), Commack
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity), Commack
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York
Memorial Sloan Kettering Nassau (Limited Protocol Activites), Rockville Centre

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.