NCT07899892 · Memorial Sloan Kettering Cancer Center
A Study of 68Ga-FAPI Breast PET/MRI Scans in People With Breast Cancer
What this study is about
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.
View original scientific description
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 outcome measures
Number of participants able to complete all 3 planned scans
Time frame: Up to 1 year
The primary aim of the study is to assess the feasibility to non-invasively assess response to NAC with 68Ga-FAPI-PET/MRI. Feasibility is given if a participant is able to complete all 3 planned scans.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
Where
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Rockville Centre, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 28, 2026 · Source of record for eligibility and locations