Recruiting
A Study of 68Ga-FAPI Breast PET/MRI Scans in People With Breast Cancer
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.
ClinicalTrials.gov IDNCT07899892
PhasePHASE1
Enrollment10
SponsorMemorial Sloan Kettering Cancer Center
Age18 Years and older
SexALL
Conditions studied
Breast Cancer, Invasive Breast Cancer
About this 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.
Interventions
- Diagnostic Test: 68Ga-FAPI-PET/MRI — 68Ga-FAPI-PET/MRI is conducted 3 times in every participant.
Primary outcomes
- Number of participants able to complete all 3 planned scans (Up to 1 year)
Eligibility information
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)
Study locations
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey 07920 United States
- Memorial Sloan Kettering Monmouth (Limited protocol activities), Middletown, New Jersey 07748 United States
- Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey 07645 United States
- Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity), Commack, New York 11725 United States
- Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activity), Commack, New York 11725 United States
- Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York 10604 United States
- Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York 10065 United States
- Memorial Sloan Kettering Nassau (Limited Protocol Activites), Rockville Centre, New York 11553 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-03.