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

NCT07683572 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-07-06

No results posted yet for this study

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.

Conditions

  • Breast Cancer
  • Breast Neoplasms
  • Sentinel Lymph Node
  • Lymphatic Metastasis

Interventions

DEVICE

AR-ICG near-infrared fluorescence imaging

Augmented-reality goggle-based near-infrared fluorescence imaging with indocyanine green (ICG), used to visualize and mark candidate sentinel lymph nodes during breast cancer surgery. Intraoperative near-infrared imaging may also be recorded by an observer for device-performance assessment. Imaging does not alter surgical management; histopathology serves as the reference standard.

Sponsors & Collaborators

  • University of Illinois at Urbana-Champaign

    collaborator OTHER

  • Ss. Cyril and Methodius University of Skopje

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2028-07-01
Completion
2028-12-31

Countries

  • North Macedonia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07683572 on ClinicalTrials.gov