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Background <p>Sentinel lymph node biopsy (SLNB) using dual tracer techniques remains the gold standard for axillary staging in early breast cancer. However, reliance on radioisotope mapping introduces logistical complexity, cost, and radiation exposure. Indocyanine green (ICG) fluorescence imaging has emerged as a potential single-tracer alternative, but concerns remain regarding its reliability across heterogeneous patient populations.</p> Methods <p>A prospective single-centre cohort study was conducted including 300 consecutive SLNB procedures across 292 unique patients using ICG as the sole tracer. The primary endpoints were nodal procedural detection rate and ICG nodal detection rate. Secondary outcomes included: nodal positivity, number of nodes retrieved, operative time, the influence of patient, tumour, and procedural variables. Statistical analysis included linear and logistic regression and correlation analysis.</p> Results <p>Procedural nodal detection was achieved in 99.7% (299/300) of procedures, while ICG fluorescent nodal detection was achieved in 97.7% (293/300). Median surgeon–pathologist nodal concordance was 100% (IQR 50–100%), with complete count agreement in 50.7% of procedures. Detection was not influenced by age, body mass index (BMI), tumour size, or procedure type. Operative time increased significantly with BMI (<i>p</i> = 0.0118) and breast-conserving surgery (<i>p</i> &lt; 0.0001).</p> Conclusions <p>This large UK prospective series demonstrates that ICG-only fluorescence guidance is safe, efficient, and reproducible, with high procedural and nodal detection rates. Naked-eye visibility of ICG was observed in a subset of cases, further supporting its practicality. Performance was consistent across surgical procedures and patient BMI. These findings support broader adoption of ICG as a single tracer for SLNB.</p>

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ICG-only Sentinel Lymph Node Biopsy in Breast Cancer: A Prospective UK Cohort Demonstrating Consistent Detection Across Patient and Tumour Characteristics—A Follow-on to the INFLUENCE Trial

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年7月29日

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  • Vassilis Pitsinis,
  • Nadia Khitab,
  • Lee Jordan,
  • Alessio Vinci,
  • Rahul Kanitkar,
  • Emad Elseedawy,
  • Jennifer Smith

摘要

Background

Sentinel lymph node biopsy (SLNB) using dual tracer techniques remains the gold standard for axillary staging in early breast cancer. However, reliance on radioisotope mapping introduces logistical complexity, cost, and radiation exposure. Indocyanine green (ICG) fluorescence imaging has emerged as a potential single-tracer alternative, but concerns remain regarding its reliability across heterogeneous patient populations.

Methods

A prospective single-centre cohort study was conducted including 300 consecutive SLNB procedures across 292 unique patients using ICG as the sole tracer. The primary endpoints were nodal procedural detection rate and ICG nodal detection rate. Secondary outcomes included: nodal positivity, number of nodes retrieved, operative time, the influence of patient, tumour, and procedural variables. Statistical analysis included linear and logistic regression and correlation analysis.

Results

Procedural nodal detection was achieved in 99.7% (299/300) of procedures, while ICG fluorescent nodal detection was achieved in 97.7% (293/300). Median surgeon–pathologist nodal concordance was 100% (IQR 50–100%), with complete count agreement in 50.7% of procedures. Detection was not influenced by age, body mass index (BMI), tumour size, or procedure type. Operative time increased significantly with BMI (p = 0.0118) and breast-conserving surgery (p < 0.0001).

Conclusions

This large UK prospective series demonstrates that ICG-only fluorescence guidance is safe, efficient, and reproducible, with high procedural and nodal detection rates. Naked-eye visibility of ICG was observed in a subset of cases, further supporting its practicality. Performance was consistent across surgical procedures and patient BMI. These findings support broader adoption of ICG as a single tracer for SLNB.