Accurate margin assessment remains a significant challenge during breast-conserving surgery. Currently, ICG fluorescence imaging is emerging as a promising tool for real-time detection of tumoral tissues. However, existing literature shows significant inconsistency regarding the ideal dosage and timing for Indocyanine Green (ICG) administration. The BREASTIFLU-1 trial aims to resolve these discrepancies by establishing a standardized protocol for surgical oncology.

The Role of ICG Fluorescence Imaging in Surgery

The BREASTIFLU-1 study is a phase II, five-arm, randomized diagnostic accuracy trial involving 227 patients. Researchers are investigating how different intravenous ICG doses impact the identification of positive surgical margins. Specifically, the trial compares intraoperative administration at induction with preoperative administration 24 hours before surgery. By analyzing dose-timing variables, the study seeks to maximize the diagnostic sensitivity and specificity of the procedure.

Furthermore, this research explores the characterization of breast tumor fluorescence and axillary lymph node intensity. Consequently, the findings could provide surgeons with a rapid, easy-to-use method for ensuring complete tumor removal. Reducing positive margin rates is essential because it directly lowers the need for stressful secondary surgeries. Additionally, standardized

ICG fluorescence imaging

protocols will likely improve clinical outcomes for early-stage breast cancer patients globally.

Future Implications for Clinical Practice

Expected results in 2026 will likely define the gold standard for ICG use in breast surgery. Notably, this trial is the first to directly compare intraoperative and preoperative administration timeframes. Therefore, it serves as a crucial step toward the formal integration of fluorescence-guided surgery into routine oncological care. Surgeons in India and worldwide can look forward to more precise tools for breast conservation.

Frequently Asked Questions

How does ICG help in breast cancer surgery?

ICG fluorescence imaging allows surgeons to see cancerous cells that might be invisible to the naked eye. This helps in achieving clear margins and identifying sentinel lymph nodes more effectively.

Why does the timing of ICG injection matter?

Timing is critical for ensuring the dye accumulates sufficiently in the tumor while clearing from healthy surrounding tissue. This contrast is necessary for high-accuracy margin assessment.

Is ICG imaging safe for all patients?

While ICG is generally safe and well-tolerated, it contains iodine. Patients with known iodine allergies or severe renal impairment should consult their surgical team before use.

Disclaimer: This content is for informational and educational purposes only. It does not constitute medical advice, diagnosis, or treatment. Always seek the advice of a qualified healthcare provider with any questions regarding a medical condition. Refer to the latest local and national guidelines for clinical practice.

References

Pop CF et al. Intraoperative breast cancer margin evaluation using fluorescence imaging with intravenous injection of indocyanine green (BREASTIFLU-1): study protocol for a randomized diagnostic accuracy trial of quantitative dose-timing assessment. Trials. 2026 Mar 03. doi: 10.1186/s13063-026-09577-8. PMID: 41772708.

Verbeek FP et al. Near-infrared fluorescence imaging in the treatment of breast cancer: a review. Breast Cancer Research and Treatment. 2014;143(1):1-11.

ClinicalTrials.gov. Dose-timing Assessment of ICG-fluorescence Imaging for Breast Cancer Margin Evaluation (BREASTIFLU-1). NCT06227338.

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