RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

Phase I/IIa Study of Pre-operative Multiparametric MRI and pHLIP® ICG Intra-operative Fluorescence Imaging of Primary Breast Cancer

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 - No contraindications for MRI or MRI contrast agents or high-field MRI (3T) - ECOG performance of 0-2 Who Should NOT Join This Trial: - Life expectancy \< 3 months - Pregnancy or lactation - Known contrast agent allergies that require premedication before MRI. - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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 * 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. * 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

Treatments Being Tested

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 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.

Locations (2)

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States