A Study of Multiparametric MRI and pHLIP® ICG in Breast Cancer Imaging During Surgery
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ClinicalTrials.gov Identifier: NCT05130801 |
Recruitment Status :
Recruiting
First Posted : November 23, 2021
Last Update Posted : December 27, 2022
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer | Diagnostic Test: pHLIP® ICG NIRF imaging | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 43 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Phase I/IIa Study of Pre-operative Multiparametric MRI and pHLIP® ICG Intra-operative Fluorescence Imaging of Primary Breast Cancer |
Actual Study Start Date : | November 19, 2021 |
Estimated Primary Completion Date : | November 2023 |
Estimated Study Completion Date : | November 2023 |

Arm | Intervention/treatment |
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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.
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Diagnostic Test: 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 |
- Dose-limiting toxicity (DLT) [ Time Frame: 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.

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Breast Cancer |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 21 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
- No contraindications for MRI or MRI contrast agents or high-field MRI (3T)
- ECOG performance of 0-2
Exclusion Criteria:
- Life expectancy < 3 months
- Pregnancy or lactation
- Known contrast agent allergies that require premedication before MRI.
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Patients who cannot undergo multiparametric MRI scanning because of:
- Weight limits. MRI scanners may not be able to function with patients over 450 pounds.
- Severe claustrophobia/ examination associated anxiety.
- MRI unsafe implant
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05130801
Contact: Katja Pinker-Domenig, MD, PhD | 646-888-5470 | pinkerdk@mskcc.org | |
Contact: Monica Morrow, MD | 646-888-5350 |
United States, New Jersey | |
Memorial Sloan Kettering Bergen (All Protocol Activities) | Recruiting |
Montvale, New Jersey, United States, 07645 | |
Contact: Katja Pinker-Domenig, MD, PhD 646-888-5470 | |
United States, New York | |
Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting |
New York, New York, United States, 10065 | |
Contact: Katja Pinker-Domenig, MD, PhD 646-888-5470 |
Principal Investigator: | Katja Pinker-Domenig, MD, PhD | Memorial Sloan Kettering Cancer Center |
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT05130801 |
Other Study ID Numbers: |
21-225 |
First Posted: | November 23, 2021 Key Record Dates |
Last Update Posted: | December 27, 2022 |
Last Verified: | December 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
MRI pHLIP® ICG Imaging Tumor stage T1-T2 21-225 |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |