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PubMed · 42684555

Use of indocyanine green fluorescence versus patent blue V dye for sentinel lymph node biopsy in early breast cancer, a randomized controlled trial.

Muhammad Nida·Ashraf Abdelmoghny·Ahmed G Osman·Mohammad A Abd-erRazik·Dina M Hanafy
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Abstract

BACKGROUND: Sentinel lymph node biopsy (SLNB) is standard for axillary staging in early breast cancer. While the combination of radioisotope and blue dye (e.g., patent blue V, PBV) remains the standard, it has limitations including logistics, variable identification rate (IR), and allergic potential. Indocyanine green (ICG) fluorescence is a promising alternative, but high-quality comparative evidence is needed. METHODS: This was a single-center, prospective, randomized controlled trial. Forty patients with early-stage, node-negative breast cancer were allocated to SLNB using either ICG (n&#x2009;=&#x2009;20) or PBV (n&#x2009;=&#x2009;20). All patients subsequently underwent completion level I-II axillary lymph node dissection (ALND) as the pathological reference standard for diagnostic performance assessment. Primary outcome was sentinel lymph node (SLN) IR. Secondary outcomes included detection time, number of SLNs retrieved, false-negative rate (FNR), and safety. RESULTS: Baseline characteristics were comparable between groups. The SLN IR was significantly higher with ICG (100% [20/20]) than with PBV (75% [15/20], p&#x2009;=&#x2009;0.047). ICG was associated with a significantly shorter median detection time (14.5 vs. 24.0&#xa0;min, p&#x2009;<&#x2009;0.001) and retrieved more SLNs (mean: 3.6 vs. 2.4, p&#x2009;=&#x2009;0.002). Most critically, ICG demonstrated 100% sensitivity, specificity, negative predictive value (NPV), and overall diagnostic accuracy, with a 0% FNR. In contrast, PBV achieved a sensitivity of 75%, an overall diagnostic accuracy of 90%, and an FNR of 25%. No ICG-related adverse events occurred. PBV caused skin discoloration in 75% of patients and one (5%) allergic reaction. CONCLUSION: ICG fluorescence achieved a higher SLN IR, shorter detection time, higher sensitivity, lower FNR, and fewer tracer-related adverse events than PBV as a single tracer for SLNB in patients with early-stage breast cancer. These findings suggest that ICG is a promising standalone tracer when radioisotope mapping is unavailable. Larger multicenter studies are required before widespread adoption can be recommended.

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HumansFemaleSentinel Lymph Node BiopsyIndocyanine GreenBreast NeoplasmsMiddle AgedFluorescenceRosaniline DyesNeoplasm StagingAdultProspective StudiesAgedColoring AgentsLymphatic MetastasisSentinel Lymph NodeLymph Node ExcisionBreast CancerIndocyanine Green FluorescencePatent Blue VJournal ArticleRandomized Controlled TrialComparative Study

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Muhammad Nida, Ashraf Abdelmoghny, Ahmed G Osman, Mohammad A Abd-erRazik, Dina M Hanafy. 2026-09-02. Use of indocyanine green fluorescence versus patent blue V dye for sentinel lymph node biopsy in early breast cancer, a randomized controlled trial.. https://doi.org/10.1186/s43046-026-00403-5

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Journal Article; Randomized Controlled Trial; Comparative Study resourceAdult subjectAged subjectBreast Neoplasms subjectComparative Study subjectFemale subjectHumans subjectJournal Article subjectMiddle Aged subjectProspective Studies subjectRandomized controlled trials study

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