Abstract PS5-08-06: A prospective, multicenter comparative pilot study to evaluate targeting axillary lymph node surgery for patients with clinically node-positive breast cancer (LUCAS study, KBCSG36)
Abstract
Accurate targeting of axillary lymph nodes (ALNs) is important in breast cancer surgery, especially in patients with ALNs metastasis. Conventional methods such as charcoal tattooing, needle localization, clips or skin marking with ultrasound have significant limitations: incorrect targeting, rapid dispersion, irreversible pigmentation, or dislocation, complicating precise localization. LuminoMark, a novel near-infrared fluorescence (NIRF) imaging agent combining indocyanine green (ICG) with a dispersion-limiting polymer, offers real-time visualization of ALNs without staining or dislocation risk.
This multicenter, prospective study aims to evaluate the safety and efficacy of LuminoMark compared to standard ALN-targeting methods (charcoal tattooing, needle localization, and ultrasound-guided skin marking). The study includes 330 breast cancer patients (165 per group), including those undergoing upfront surgery or surgery following neoadjuvant chemotherapy. The experimental group receives a 0.2-mL subcutaneous injection of LuminoMark into pathologically confirmed metastatic ALNs prior to surgery, while the control group follows institutional standard targeting procedures. The primary outcome is the successful detection rate of the targeted lymph node and check-up of adverse events, and secondary outcomes include time from incision to node detection, total axillary surgical time, postoperative complications, and correlation with sentinel lymph nodes. A prior Phase 2 trial…
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