Abstract
BackgroundRecent studies show that near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has the potential to improve the performance of sentinel lymph node (SLN) mapping. The current cohort study was designed to assess the value of the combination of ICG and methylene blue (MB) dye in patients undergoing SLN biopsy.MethodsA prospective self-controlled trial was designed to detect the difference in the detection efficacies of ICG, MB, and combined ICG and MB (ICG + MB) navigation methods. Between 2010 and 2013, 198 consecutive early breast cancer patients eligible for sentinel lymph node biopsy were enrolled and 200 biopsy procedures were performed by injection of both ICG and MB. SLNs were searched and removed under the guidance of fluorescence and/or blue dye. The mapping characteristics, the detection rate of SLNs and positive SLNs, and the number of SLNs of ICG, MB, and ICG + MB were compared. Injection safety of ICG and MB was evaluated.ResultsFluorescence imaging of lymphatic flow, which is helpful to locate the incision site, could be seen in 184 of 200 procedures. The nodal detection rate of ICG, MB, and ICG + MB samples was 97, 89, and 99.5% (χ2 = 26.2, p < 0.001), respectively, with the combination method yielding a superior identification result. The addition of ICG to the MB method resulted in the identification of more lymph nodes (median 3 versus 2) and more positive axillas (22.7% involved axillas were discovered by fluorescence only) than either method alone. No acute or chronic allergic reaction was observed in this study. However, 23 patients (23/82) who received breast-conserving therapy reported temporary skin staining, and 5 patients had permanent tattooing. Palpable subcutaneous nodules at the injection sites were reported in nine patients. There were no reports of skin necrosis.ConclusionsThe lymphatic navigation by ICG fluorescence detects SLNs at a high detection rate and improves the mapping performance when added to the MB method. The novel ICG + MB dual tracing modality, without involvement of radioactive isotopes, exhibits great potential as an alternative to traditional standard mapping methods.Trial registrationACTRN12612000109808. Retrospectively registered on 23 January 2012.
Highlights
Recent studies show that near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has the potential to improve the performance of sentinel lymph node (SLN) mapping
A routine incision used in dye-guided sentinel lymph node biopsy (SLNB) in the armpit was made in the other 16 procedures
The overall SLN detection rates for the ICG and dual methods were 97 and 99.5%, respectively, while the detection rate for dye alone was 89% (χ2 = 26.2, p < 0.001)
Summary
Recent studies show that near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has the potential to improve the performance of sentinel lymph node (SLN) mapping. The current cohort study was designed to assess the value of the combination of ICG and methylene blue (MB) dye in patients undergoing SLN biopsy. Axillary lymph node staging by sentinel lymph node biopsy (SLNB) is a widely used method and is regarded as a standard of care in patients without clinical evidence of axillary lymph node metastasis in early breast cancer [1]. The existing standard SLNB method is a dual technique involving the injection of a technetium-99m (99mTc)-labeled nanocolloid and blue dye [2]. Constraints of radioisotopes have led to the development of non-radioactive alternative methods. Some investigators maintained that the use of blue dye alone leads to a lower SLN identification rate [12], which might draw concerns about the potential adverse impact on longterm prognosis [13]
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