Purpose: To assess the diagnostic performance of sentinel lymph node (SLN) biopsy using the indocyanine green (ICG) fluorescence method compared with that using the blue dye method, a prospective multicenter study was performed.
Methods: Patients with T1-3 primary breast cancer without clinical lymph node involvement were included in this study. ICG as a fluorescence-emitting source and indigo carmine as blue dye were injected into the subareolar area. Extracted lymph nodes were examined to identify the first, second, and other SLNs. The identified nodes were classified according to the ICG fluorescence signal and blue dye uptake.
Results: Ninety-nine eligible patients were included in this study. The ICG fluorescence method identified an average of 3.4 SLNs (range, 1-8) in 98 of 99 patients (detection rate, 99 %). The number of lymph nodes identified by the fluorescence method was significantly higher than that identified by the blue dye method (p < 0.001). SLN involvement was identified in 20 % (20 of 99) of patients, all of whom tested positive for the first SLN. In 16 patients, complete axillary lymph node dissection (ALND) was performed. In 25 % (4 of 16) of these patients, axillary metastases were identified; however, no axillary involvement was found in 8 patients with only one involved node, which was isolated as the first SLN.
Conclusions: High rate of SLN detection was achieved using the ICG fluorescence method. The first SLN identified by fluorescence imaging provides an exact indication of the axillary status. Therefore, the ICG fluorescence method provides precise information required to avoid unnecessary ALND.