Actively Recruiting
A Study of Multiparametric MRI and pHLIP® ICG in Breast Cancer Imaging During Surgery
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-22
55
Participants Needed
2
Research Sites
310 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
S
Stryker Instruments
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to find out whether pre-operative mpMRI using additional MRI sequences may improve surgical outcomes by providing more accurate information about the extent and acidity of the tumor than standard MRI, and to see whether the use of the fluorescent imaging agent pHLIP ICG and NIRF imaging during surgery is a safe approach that may allow the surgeon to see the tumor and nearby tissues that contain cancer cells more clearly and remove them completely. During the Phase IIa part of this study, the safe dose of pHLIP ICG will be used that makes it easy for the surgeon to see the tumor and the nearby tissues and structures that may contain cancer cells. This study is the first to test pHLIP ICG in people, and the first to test the use of pHLIP ICG with mpMRI and NIRF imaging in surgery for breast cancer.
CONDITIONS
Official Title
A Study of Multiparametric MRI and pHLIP® ICG in Breast Cancer Imaging During Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or greater
- Biopsy proven primary breast malignancy (BI-RADS 6)
- Tumor stage Tis, T1 and T2 with lesion size greater than 1 cm
- Planned primary surgical treatment with breast conservation
- No previous treatment for breast cancer
- ECOG performance status of 0 to 2
You will not qualify if you...
- Life expectancy less than 3 months
- Pregnancy or lactation
- Known metastatic liver disease, hepatic neoplasms, biliary atresia, chronic liver disease, or cirrhosis
- Known moderate hepatic impairment (phase I and phase IIa depending on safety profile)
- Known hypersensitivity to indocyanine green
- Impaired decision-making capacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
2
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
Research Team
C
Clarissa Lin, MD
CONTACT
M
Monica Morrow, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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