Abstract
OBJECTIVE: This randomized study aimed to compare the clinical efficacy between the novel dual tracer composed of indocyanine green (ICG) and blue dye (BD) and the conventional dual tracer composed of radioisotope and BD for sentinel lymph node (SLN) mapping in patients with breast cancer. METHODS: This study enrolled 471 clinically lymph node-negative patients with primary breast cancer. All patients underwent mastectomy, and those undergoing sentinel lymph node biopsy (SLNB) were randomized to receive blue dye plus radioisotope (RB group) or BD plus ICG (IB group). The detection performances on SLN identification rate, positive SLN counts, detection sensitivity, and false-negative rate were compared between the two groups. RESULTS: In the IB group, 97% (194/200) of the patients who underwent the ICG and BD dual tracer injection showed fluorescent-positive lymphatic vessels within 2-5 min. The identification rate of SLNs was comparable between the IB group (99.0%, 198/200) and the RB group (99.6%, 270/271) (P = 0.79). No significant differences were observed in the identification rate of metastatic SLNs (22.5% vs. 22.9%, P > 0.05, RB group vs. IB group, the same below), positive SLN counts (3.72 ± 2.28 vs. 3.91 ± 2.13, P > 0.05), positive metastatic SLN counts (0.38 ± 0.84 vs. 0.34 ± 0.78, P > 0.05), SLNB detection sensitivity (94.4% vs. 92.5%, P > 0.05), or false-negative rate (5.6% vs. 7.5%, P > 0.05) between the two groups. CONCLUSIONS: ICG can be used as a promising alternative tracer for radioisotope in SLN mapping, and when it is combined with BD in lymphangiography, it offers comparable detection sensitivity compared to the conventional lymphatic mapping strategies that are widely used in clinical practice.