Recruiting
Phase 1
Phase 2

MRI & pHLIP® ICG

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05130801

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

pHLIP® ICG NIRF imaging

Study Details

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

Study ID

NCT05130801

Start date

Nov 19, 2021

Status verified date

Sep, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

55 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: MRI and pHLIP® ICG

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.

Interventions

pHLIP® ICG NIRF imaging

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.

Primary outcome measure

  • Dose-limiting toxicity (DLT) [ Time Frame: 15 days post pHLIP® ICG injection ]
  • Concordance between the absence of optical signal and histopathological confirmation of absence of malignancy. (Phase II) [ Time Frame: 1 year ]
  • Visualization of a lesion with pHLIP® ICG (Phase II) [ Time Frame: up to 6 months ]

Central Contacts and Locations

Central contacts

Giacomo Montagna, MD

646-888-6891montagng@mskcc.org

Monica Morrow, MD

646-888-5350

Locations

Memorial Sloan Kettering Bergen (All Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Giacomo Montagna, MD

646-888-6891

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Giacomo Montagna, MD

646-888-6891

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-09-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.