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Study of pHLIP® ICG and MRI for Breast Cancer Surgery

This study is looking at new ways to improve breast cancer surgery. Researchers want to see if using special MRI scans (multiparametric MRI) before surgery can give doctors more accurate information about your tumor. They are also testing a fluorescent imaging agent called pHLIP® ICG. This agent is injected before surgery and helps surgeons see the tumor and any nearby cancer cells more clearly during the operation. The goal is to help surgeons remove all cancer cells completely. This study is for women with early-stage breast cancer who are having breast-conserving surgery. The main goals are to check for any side effects from pHLIP® ICG and to see how well it helps visualize the tumor during surgery.

Study design
This is an interventional study with a planned enrollment of 55 women. It is a Phase I/IIa study, meaning it will first check for safety and then how well the intervention works.
What's involved
You would have a research MRI 1-3 weeks before surgery. A single injection of pHLIP® ICG would be given one day before surgery. Blood and urine samples would also be collected.
Compensation
Not stated in the trial record.
Follow-up
You would be monitored for side effects for 15 days after the pHLIP® ICG injection, and for tumor visualization up to 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05130801

A Study of Multiparametric MRI and pHLIP® ICG in Breast Cancer Imaging During Surgery

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
Memorial Sloan Kettering Cancer Center
~55 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:pHLIP® ICG NIRF imaging

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting toxicity (DLT)
Measured over 15 days post pHLIP® ICG injection
+1 more outcome measured

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

2 sites across 2 states
New Jersey1
New York1

Study leadership

  • Clarissa Lin, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Clarissa Lin, MD
[email protected]
646-888-5119
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 18 years or greater
Biopsy proven primary breast malignancy (BI-RADS 6)
Tumor stage Tis, T1 and T2, lesion size \> 1 cm
Primary surgical treatment with breast conservation
No previous treatment
ECOG performance of 0-2

Exclusion

Life expectancy \< 3 months
Pregnancy or lactation
Known metastatic liver disease, hepatic neoplasms (benign and malignant), biliary atresia, chronic liver disease (CLD) and cirrhosis.
Known moderate hepatic impairment (in phase I, and in phase IIa dependent on safety profile established in phase I)
Known hypersensitivity to indocyanine green.
Individuals with impaired-decision making capacity

What this trial measures

  • Dose-limiting toxicity (DLT)15 days post pHLIP® ICG injection

    is defined as a clinically significant adverse event recorded within 3 hours after pHLIP® ICG administration or an abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, surgery, or concomitant medications, and meets the NCI common terminology criteria that are CTCAE Grade 3 or 4.

  • Visualization of a lesion with pHLIP® ICG (Phase II)up to 6 months

    The visualization of a lesion with pHLIP® ICG NIRF (Likert score is ≥1) will be considered positive for malignancy. No visualization of a lesion or visualization at the background level (Likert score is 0) with pHLIP® ICG NIRF will be considered negative for malignancy.