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

"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."