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Life sciences · Interventional Study
ClinicalTrials.gov · November 6, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07696754). This is a study registration, not published results. Lead sponsor: Ss. Cyril and Methodius University of Skopje. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 200 participants (ESTIMATED). Conditions: Breast Cancer, Breast Neoplasms, Sentinel Lymph Node, Lymphatic Metastasis. Interventions: DEVICE: Augmented-reality ICG fluorescence second-look imaging. Primary outcome measures: Patient-level rate of clinically significant events (CSE) , From intraoperative second-look review to final histopathology (up to approximately 2 weeks after surgery). Brief summary: This prospective study will enroll up to 200 patients whose clinical team has already planned an axillary lymph node dissection for breast cancer. After the surgeon completes the planned dissection and declares that no further tissue was intended for removal, a wearable augmented-reality/virtual-reality (AR/VR) system will show indocyanine-green (ICG) near-infrared fluorescence during a brief second look at the exposed surgical field. The surgeon may remove an additional fluorescent focus only after inspection under normal light and only when removal is safe and clinically appropriate. Each additional specimen will be labeled separately and examined by pathology. The study measures the proportion of patients with an additional tumor-positive lymph node found at second look, whether such nodes change the pathological nodal category, operating time, and adverse events. The first 50 consecutive participants will form a planned descriptive device-feasibility analysis; all 200 participants will contribute to the full-cohort clinical analysis. The study does not assume that finding an additional node improves recurrence or survival.