Integrated Imaging System (SmartGoggles) in Detecting Fluorescently Labeled Sentinel Lymph Nodes in Patients with Breast Cancer

PRIMARY OBJECTIVE:

I. To measure how closely through fluorescent lymph nodes (LN) (as detected by the SmartGoggles) matches with the LN as determined by gold standard (based on gamma tracers detected Geiger counter and pathology for positive lymph nodes).

SECONDARY OBJECTIVES:

I. Characterize the sensitivity of the SmartGoggles device, relative to a previously validated device (fluorescence imaging systems).

II. To determine the surgeons preference for using the Googles for indocyanine green dye (ICG) detection versus the current near-infrared (NIR) cameras.

OUTLINE:

Patients undergo baseline measurements using SmartGoggles and SPY Elite imaging system from a nonlesional control area on the posterior upper leg. Patients receive indocyanine green, Technetium TC-99m colloid, and methylene blue periareolarly. Patients then undergo imaging using SmartGoggles over 20 minutes. Patients also undergo imaging using SPY Elite device and the gold standard (Technetium TC-99m colloid and methylene blue). Patients undergo biopsy at the time of first detection of fluorescence for each sentinel lymph node (SLN).