What this study is
Simplified from ClinicalTrials.govTesting a type of imaging scan (68Ga-FAPI PET/MRI) to learn if it is practical for checking how well breast cancer responds to chemotherapy given before surgery, in adults 18 and older who are getting that chemotherapy.
Read the original summary from ClinicalTrials.gov
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's being tested
- 68Ga-FAPI-PET/MRI
Intervention · DIAGNOSTIC TEST
68Ga-FAPI-PET/MRI is conducted 3 times in every participant.
Study details
- Official title
- A Prospective Study to Evaluate the Feasibility of 68Ga-FAPI Breast PET/MRI in Diagnosing a Breast Cancer Pathologic Complete Response Following Neoadjuvant Chemotherapy
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Breast Cancer · Invasive Breast Cancer
- Enrolling
- 10 people
- Starts
- 2026-10-20
- Est. completion
- 2028-10-20
- Design
- Open-label, single group, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (8)
8 openContact for 5 of 8 open sites
- Somali Gavane, MD · Contact212-639-2403
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
RecruitingMemorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, United States
RecruitingMemorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
RecruitingMemorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, United States
- Simone Gavane, MD · Contact212-639-2403
RecruitingMemorial Sloan Kettering Suffolk-Commack (Limited Protocol Activity)
Commack, New York, United States
RecruitingMemorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
- Simone Gavane, MD · Contact212-639-2403
RecruitingMemorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
RecruitingMemorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, United States
- Simone Gavane, MD · Contact212-639-2403
Recruiting
Study team
Sponsor
Memorial Sloan Kettering Cancer Center
Study ID 26-320
Principal investigator
Somali Gavane, MD
Memorial Sloan Kettering Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.