ICG Fluorescence Technique for the Detection of Sentinel Lymph Nodes in Breast Cancer: Results of a Prospective Open-label Clinical Trial

 

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Abstract

Introduction: Detection of sentinel lymph nodes (SLN) is the standard procedure to evaluate axillary lymph node status in breast cancer. In addition to known and established procedures such as the blue dye method and scintigraphy, this study investigated the efficacy of a method based on use of the fluorescent dye indocyanine green (ICG). Patients and Method: A total of 126 women with breast cancer histologically verified by punch biopsy were studied during surgical removal of SLN. In addition to SLN marking with technetium and scintigraphy, intra-individual comparison was done using indocyanine green (ICG) for marking instead of the standard blue dye. Results: Scintigraphy had a detection rate of 96 %; the detection rate with ICG was just under 89 %. A body mass index (BMI) > 40 was found to be a limiting factor for the fluorescent method. Investigation into potential toxicities associated with the use of the fluorescent dye ICG revealed no systemic or even local side effects. The fluorescent method was found to be significantly less expensive than the scintigraphy method. Conclusion: The ICG fluorescence technique for the detection of SLN was found to be a valid and feasible method in clinical practice when compared directly with the blue dye method and scintigraphy.

Zusammenfassung

Einleitung: Die Detektion des Sentinel-Lymphknotens (SLN) ist mittlerweile ein Standardverfahren zur Erfassung des axillären Lymphknotenstatus beim Mammakarzinom. Neben den bekannten und etablierten Verfahren, wie der blauen Farbstoffmethode und dem szintigrafischen Verfahren, wurde in der vorliegenden Untersuchung die Aussagefähigkeit einer Methode überprüft, basierend auf dem Einsatz eines Fluoreszenzfarbstoffs in Form von Indocyaningrün (ICG). Patientinnen und Methoden: Untersucht wurden dabei insges. 126 Patientinnen mit durch Stanzbiopsie histologisch gesichertem Mammakarzinom im Rahmen der operativen Entfernung des SLN. Neben einer standardmäßigen szintigrafischen Markierung des SLN mittels Technetium erfolgte im intraindividuellen Vergleich anstelle der üblichen Blaumarkierung die Markierung mittels Indocyaningrün (ICG). Ergebnisse: Es konnte mit der Szintigrafie eine Detektionsrate von 96 % erreicht werden, mittels ICG eine Rate von knapp 89 %. Als limitierender Faktor für das Fluoreszenzverfahren erwies sich ein Body-Mass-Index > 40 (BMI > 40). Die Erfassung von möglicherweise auftretenden Toxizitäten bei Anwendung des Fluoreszenzfarbstoffs ICG ergab keinen Hinweis auf systemische oder auch lokale Nebenwirkungen. Im Kostenvergleich erweist sich die Fluoreszenztechnik als deutlich kostengünstiger als das szintigrafische Verfahren. Schlussfolgerung: Die SLN-Detektion mittels Fluoreszenzverfahren durch Einsatz von ICG erweist sich im klinischen Einsatz und direktem Vergleich zur blauen Farbstoffmethode und dem szintigrafischen Verfahren als valides und praktikables Verfahren.

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