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.
Histologically proven breast cancer
Age 18 years or older
Undergoing breast cancer surgery with sentinel lymph node evaluation and/or axillary lymph node dissection
Provides written informed consent
Pregnancy
Neoadjuvant chemotherapy
Prior breast surgery
Iodine or seafood allergy
Ss. Cyril and Methodius University of Skopje
Lead sponsor
University of Illinois at Urbana-Champaign
Collaborator