• Annals of surgery · Nov 2022

    Sentinel Lymph Node Mapping in Breast Cancer Patients through Fluorescent Imaging using Indocyanine Green - the INFLUENCE trial.

    • Claudia A Bargon, Anne Huibers, Danny A Young-Afat, Britt A M Jansen, Borel-RinkesInne H MIHMDepartment of Endocrine Surgical Oncology, University Medical Center Utrecht, Utrecht, The Netherlands., Jules Lavalaye, Henk-Jan van Slooten, Helena M Verkooijen, Christiaan F P van Swol, and Annemiek Doeksen.
    • Division of Imaging and Oncology, University Medical Centre (UMC) Utrecht, Utrecht, The Netherlands.
    • Ann. Surg. 2022 Nov 1; 276 (5): 913-920.

    ObjectiveThe aim was to compare the (sentinel) lymph node detection rate of indocyanine green (ICG)-fluorescent imaging versus standard-of-care 99m Tc-nanocoilloid for sentinel lymph node (SLN)-mapping.BackgroundThe current gold standard for axillary staging in patients with breast cancer is sentinel lymph node biopsy (SLNB) using radio-guided surgery using radioisotope technetium ( 99m Tc), sometimes combined with blue dye. A promising alternative is fluorescent imaging using ICG.MethodsIn this noninferiority trial, we enrolled 102 consecutive patients with invasive early-stage, clinically node-negative breast cancer. Patients were planned for breast conserving surgery and SLNB between August 2020 and June 2021. The day or morning before surgery, patients were injected with 99m Tc-nanocolloid. In each patient, SLNB was first performed using ICG-fluorescent imaging, after which excised lymph nodes were tested with the gamma-probe for 99m Tc-uptake ex vivo, and the axilla was checked for residual 99m Tc-activity. The detection rate was defined as the proportion of patients in whom at least 1 (S)LN was detected with either tracer.ResultsIn total, 103 SLNBs were analyzed. The detection rate of ICG-fluorescence was 96.1% [95% confidence interval (95% CI)=90.4%-98.9%] versus 86.4% (95% CI=78.3%-92.4%) for 99m Tc-nanocoilloid. The detection rate for pathological lymph nodes was 86.7% (95% CI=59.5%-98.3%) for both ICG and 99m Tc-nanocoilloid. A median of 2 lymph nodes were removed. ICG-fluorescent imaging did not increase detection time. No adverse events were observed.ConclusionsICG-fluorescence showed a higher (S)LN detection rate than 99m Tc-nanocoilloid, and equal detection rate for pathological (S)LNs. ICG-fluorescence may be used as a safe and effective alternative to 99m Tc-nanocoilloid for SLNB in patients with early-stage breast cancer.Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.

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