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

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Conditions studied: Breast Cancer, Breast Neoplasms, Sentinel Lymph Node, Lymphatic Metastasis

In brief

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.

Key facts

Study ID

NCT07683572

Run by

Ss. Cyril and Methodius University of Skopje

People needed

200

Starts

2026-07-01

Expected to finish

2028-12-31

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Pregnancy
• Neoadjuvant chemotherapy
• Prior breast surgery
• Iodine or seafood allergy
• Indocyanine green (ICG) allergy
• Declines or is unable to provide informed consent

Where it is running

• University Clinic for Thoracic and Vascular Surgery, Faculty of Medicine, UKIM — Skopje, North Macedonia

Full record on ClinicalTrials.gov

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