Phase II Real-Time NIR-Guided Sentinel Lymph Node Mapping in Breast Cancer
Fifty participants consented from Brigham and Women's Hospital (currently enrolling) and
Beth Israel Deaconess Medical Center (currently non-enrolling), who will be undergoing
standard of care for breast cancer SLN mapping with Tc-99m will be enrolled in this study.
Prior to surgery, patients will undergo lymphoscintigraphy as is standard of care. At the
time of SLN mapping, the patient will be injected with indocyanine green dye (ICG).
Concurrently, a custom-designed imaging platform that utilizes NIR fluorescence optics will
be employed to identify the dye and its path through the lymphatic track, and its eventual
highlighting of the SLN. Both color images and NIR images will be merged to give the
operating surgeon a clear picture of the ICG track superimposed over anatomical landmarks.
This technique will identify the SLN and provide an accurate video image of its location.
The surgeon will resect all SLNs identified by Tc-99m or NIR fluorescence, and then confirm
the radioactivity and NIR fluorescence signal in each after resection.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Sensitivity of Real-Time Intraoperative NIR Mapping
To determine the sensitivity of real-time intraoperative NIR lymphatic mapping in the identification of the sentinel lymph node in human breast cancer as compared to the standard of care, Technicium 99 (Tc-99).
One Day (day 1)
John V. Frangioni, M.D., Ph.D.
Beth Israel Deaconess Medical Center
United States: Institutional Review Board
|Dana Farber Cancer Institute||Boston, Massachusetts 02115|