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Life sciences · Observational Study
ClinicalTrials.gov · November 5, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07683572). This is a study registration, not published results. Lead sponsor: Ss. Cyril and Methodius University of Skopje. Recruitment status: WITHDRAWN. Study type: OBSERVATIONAL. Conditions: Breast Cancer, Breast Neoplasms, Sentinel Lymph Node, Lymphatic Metastasis. Interventions: DEVICE: AR-ICG near-infrared fluorescence imaging. Primary outcome measures: Node-level diagnostic accuracy of AR-ICG fluorescence imaging versus histopathology , From surgery to final histopathology (up to ~2 weeks after surgery). Brief summary: This study evaluates how accurately augmented-reality goggles with indocyanine green (ICG) near-infrared fluorescence can identify sentinel (first-draining) lymph nodes during breast cancer surgery. The goggles and ICG signal are used to mark candidate sentinel nodes, and an additional observer may record near-infrared images during the operation for device-performance assessment. These imaging findings do not change the surgical procedure. The candidate nodes and all removed tissue are examined by histopathology, which serves as the reference standard. Two hundred patients undergoing breast cancer surgery will take part. The study measures how well the goggle-based imaging detects nodes that contain cancer, compared with final pathology.