Randomized comparison between indocyanine green fluorescence plus (99m)technetium and (99m)technetium alone methods for sentinel lymph node biopsy in breast cancer

Use of both patent blue and a radioisotope to locate, and reduce the risk of sentinel lymph node (SLN) detection failure in breast cancer is recommended, but drawbacks commonly lead to using only a radioisotope. An alternative method would therefore be valuable. This randomized, controlled study in 99 patients compared SLN detection using (99m)technetium (Tc) alone versus Tc combined with indocyanine green (ICG). The primary endpoint was the SLN identification rate. The primary outcome measure was the number of patients with <2 SLN detected. One SLN was detected in 44.0% of patients in the dual detection group and 40.8% in the (99m)Tc alone group (RR = 1.08 (95% CI 0.68; 1.72), p = 0.84). A mean (±SD) of 2.14 ± 1.23 SLN were identified in the dual detection group vs. 1.77 ± 0.85 using Tc alone (p = 0.09). Eight-five (78.7%) SLN were both ICG+ and TC+, 15 (13.9%) ICG+ and Tc−, and 7 (6.5%) ICG− and Tc+. SLN detected were ICG-positive in 92.6% of patients and (99m)Tc-positive in 85.2% with. No adverse event related to ICG injection was recorded. Dual detection of SLN using ICG and radioisotope is reliable and sensitive but was not superior to isotope alone in successfully locating SLN in our pilot randomized trial.