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

NCT05130801 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 21-225
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief Summary

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

Breast Cancer

Keywords

MRI; pHLIP® ICG; Imaging; Tumor stage T1-T2; 21-225; SPY-PHI Systems

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  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.

  15 days post pHLIP® ICG injection

• Visualization of a lesion with pHLIP® ICG (Phase II)

  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.

  up to 6 months

Study Arms (1)

MRI and pHLIP® ICG

EXPERIMENTAL

All study participants in Phase I will receive pre-operative MRI and mpMRI scans, a pre-operative injection of pHLIP ICG, and NIRF imaging during surgery (intra-operatively). During phase IIa of the study, if pHLIP® ICG NIRF imaging indicates tumor in areas outside of the planned resection area, biopsy samples will be taken from these areas and submitted for pathological analysis.

Diagnostic Test: pHLIP® ICG NIRF imaging

Interventions

pHLIP® ICG NIRF imaging DIAGNOSTIC_TEST

Pre-operative research MRI will be performed 1-3 weeks prior to the surgery. single pHLIP® ICG injection will be administered i.v. by a radiologist on the protocol one day prior to scheduled surgery on the occasion of presurgical localization (12-36 hours prior to the surgery). In Phase I, we propose to investigate 4 different doses: Dose level 1 = 0.04 mg/kg Dose level 2 = 0.075 mg/kg Dose level 3 = 0.15 mg/kg Dose level 4 = 0.30 mg/kg In Phase IIa, the researchers propose to administer selected in Phase I dose of pHLIP® ICG. In Phase IIa, the researchers propose to administer pHLIP® ICG at DL2, DL3 or DL4 at different time points prior to surgery ranging from 12-110 hours, with targeted enrollment of 12 patients. Next, the selected optimal dose and timing will be used with targeted enrollment of 28 patients. The total number of subjects in Phase IIa study is 40.

MRI and pHLIP® ICG

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Breast Cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Stryker Instruments: collaborator
• pHLIP Inc.: collaborator

Study Sites (2)

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Clarissa Lin, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clarissa Lin, MD

CONTACT

646-888-5119; linc5@mskcc.org

Monica Morrow, MD

CONTACT

646-888-5350

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: November 23, 2021
• Study Start: November 19, 2021
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)