Device Validation of Augmented-Reality ICG Fluorescence Imaging for Sentinel Lymph Node Detection in Breast Cancer

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.

NCT Number	NCT07683572
Lead Sponsor	Ss. Cyril and Methodius University of Skopje Collaborators: University of Illinois at Urbana-Champaign
Conditions	Breast Cancer, Breast Neoplasms, Sentinel Lymph Node, Lymphatic Metastasis
Enrollment	200 participants
Start Date	2026-07-01
Primary Completion	2028-07-01 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-06