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

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.

Detailed Description

his protocol involves performing first-in-human imaging with pHLIP® ICG in consecutive patients with newly diagnosed primary BC (tumor stage T1-T2 with or without lymph node metastases) undergoing breast conserving treatment at MSK. All imaging will be obtained either at MRI staging before surgery and during definite surgical treatment; no additional invasive procedures will be necessary. The information collected in the phase I part of this study will not be used for diagnostic purposes, and neither will the information be used to assess the patients' response to therapy nor adjust the clinical management of the patient. 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. A standard 3+3 followed by dose expansion clinical design plus 3 patients with selected dose (the minimum number of patients is 2, the maximum number of patients is 27, and the expected number of patients is 15 assuming 3 patients per 4 dose levels and 3 additional patients with the selected dose) will be used.

Eligibility Criteria

Interventions