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Randomized Controlled Trial
. 2024 Dec;31(13):8848-8855.
doi: 10.1245/s10434-024-16176-x. Epub 2024 Sep 12.

Results of a Prospective Randomized Multicenter Study Comparing Indocyanine Green (ICG) Fluorescence Combined with a Standard Tracer Versus ICG Alone for Sentinel Lymph Node Biopsy in Early Breast Cancer: The INFLUENCE Trial

Vassilis Pitsinis  1   2   3 , Rahul Kanitkar  4 , Alessio Vinci  4   5 , Wen Ling Choong  4   5 , John Benson  6   7   8
Affiliations
Randomized Controlled Trial

Results of a Prospective Randomized Multicenter Study Comparing Indocyanine Green (ICG) Fluorescence Combined with a Standard Tracer Versus ICG Alone for Sentinel Lymph Node Biopsy in Early Breast Cancer: The INFLUENCE Trial

Vassilis Pitsinis et al. Ann Surg Oncol. 2024 Dec.

Abstract

Background: For clinically node-negative early breast cancer patients, sentinel lymph node biopsy (SLNB) using dual localization with blue dye and radioisotope (RI) is currently standard of care. Documented disadvantages with these tracers have prompted exploration of alternative agents such as fluorescent indocyanine green (ICG), which demonstrates high detection rates combined with other tracers. Results of a randomized study evaluating ICG as a single tracer for SLN identification are presented.

Methods: Overall, 100 patients with unilateral, clinically node-negative, biopsy-proven invasive breast cancer (≤5 cm) scheduled for SLNB were recruited in two separate randomized cohorts, with 50 patients receiving ICG alone. Cohort 1 received ICG alone (n = 25) or combined with RI [Technetium99] (n = 25), while Cohort 2 received ICG alone (n = 25) or combined with blue dye (n = 25). The primary outcome was sensitivity for SLN identification.

Results: Among evaluable patients (n = 97), the overall SLN identification rate was 96.9% (ICG alone = 97.9%; ICG + RI = 100%; ICG + blue dye = 92%). Node positivity rates were 14.9% for ICG alone, 16% for ICG combined with RI, and 20% for ICG combined with blue dye. There were no significant differences (p < 0.05) in performance parameters, with ICG alone being non-inferior to tracer combinations for procedural node positivity rates when adjusted for specific factors.

Conclusion: These results support potential use of ICG as a sole tracer agent for routine SLNB, thereby avoiding disadvantages of RI and/or blue dye. The latter can be safely withheld as a co-tracer without compromising detection of positive nodes in primary surgical patients.

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Conflict of interest statement

Vassilis Pitsinis, Rahul Kanitkar, Alessio Vinci, Wen Ling Choong, and John Benson have no conflicts of interest to declare that may be relevant to the contents of this study.

Figures

Fig. 1
Fig. 1
Study design
Fig. 2
Fig. 2
a Fluorescent image following periareolar injection of ICG in a right breast. ICG can be seen within the subcutaneous lymphatics coursing towards the axilla (camera on the black and white setting). b Fluorescent image of a sentinel lymph node with ICG as a single tracer (camera on green mode setting)
See this image and copyright information in PMC

References

    1. Lyman GH, Giuliano AE, Somerfield MR, et al. American Society of Clinical Oncology guideline recommendations for sentinel lymph node biopsy in early-stage breast cancer. Journal of Clinical Oncology. 2005;23(30). 10.1200/JCO.2005.08.001 - PubMed
    1. Kitai T, Inomoto T, Miwa M, Shikayama T. Fluorescence navigation with indocyanine green for detecting sentinel lymph nodes in breast cancer. Breast Cancer. 2005;12(3). 10.2325/jbcs.12.211 - PubMed
    1. Sever A, Jones S, Cox K, Weeks J, Mills P, Jones P. Preoperative localization of sentinel lymph nodes using intradermal microbubbles and contrast-enhanced ultrasonography in patients with breast cancer. British Journal of Surgery. 2009;96(11). 10.1002/bjs.6725 - PubMed
    1. Rubio IT, Diaz-Botero S, Esgueva A, et al. The superparamagnetic iron oxide is equivalent to the Tc99 radiotracer method for identifying the sentinel lymph node in breast cancer. European Journal of Surgical Oncology. 2015;41(1). 10.1016/j.ejso.2014.11.006 - PubMed
    1. Karakatsanis A, Daskalakis K, Stålberg P, et al. Superparamagnetic iron oxide nanoparticles as the sole method for sentinel node biopsy detection in patients with breast cancer. British Journal of Surgery. 2017;104(12). 10.1002/bjs.10606 - PubMed

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