Phase I/IIa Study of Pre-operative Multiparametric MRI and pHLIP® ICG Intra-operative Fluorescence Imaging of Primary Breast Cancer
Memorial Sloan Kettering Cancer Center
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.
Description
This is a phase I//IIa first-in-human clinical study of a single dose of intravenous pHLIP® ICG for intraoperative imaging of tumors in breast cancer patients undergoing breast conserving surgery. Breast cancer is a complex disease with remarkable heterogeneity. Despite the complexity of breast cancer biology, to date, the focus of its interrogation is entirely on molecular biology and cancer genomics. This clinical study aims to develop and implement a holistic approach for tumor microenvironment assessment with tumor acidity imaging with pre-operative multi-parametric MRI (mpMRI) and novel p…