ICG-Fluorescence Imaging for Sentinel Lymph Node Mapping in Patients with Stage I or IIA Breast Cancer
This early phase I trial compares indocyanine green (ICG)-fluorescence imaging to technetium TC-99m with or without isosulfan blue dye in mapping sentinel lymph nodes for biopsy in patients with stage I or IIA breast cancer. Sentinel lymph nodes are the first lymph nodes affected by cancer that is spreading from the primary cancer site. Sentinel lymph node mapping is the current standard of care for staging axillary lymph nodes to guide clinical decision making. Sentinel lymph nodes are usually identified using a radiotracer, such as technetium TC-99m, and a blue dye, such as isosulfan blue. Technetium TC-99m is a drug that contains a radioactive substance, technetium. Isosulfan blue is a dye made in the laboratory that helps identify the sentinel lymph node (the first lymph node that cancer spreads to from a primary tumor). Isosulfan blue is injected at the edge of a tumor and travels through the lymph fluid to lymph nodes near the tumor. The sentinel lymph node is identified by removing lymph nodes that are stained with the blue dye and looking for tumor cells under a microscope. This technique is effective, however, the radiotracer and dye are injected prior to the operating room which can create scheduling complications. Indocyanine green is a dye that can be visualized with fluorescence imaging techniques at the time of surgery. Using ICG-fluorescence imaging may be an acceptable technique compared to standard of care technetium TC-99m with or without isosulfan blue dye for sentinel lymph node mapping in patients with stage I or IIA breast cancer.