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.
