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NCT Number: NCT07683572

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Lymphatic Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Sentinel Lymph Node Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Clinic for Thoracic and Vascular Surgery, Faculty of Medicine, UKIM

Skopje, 1000, North Macedonia

Location contact

Borislav Kondov, MD

CONTACT

[email protected]

+38972539003

About this study

This is a prospective observational device-validation study in patients undergoing breast cancer surgery with axillary evaluation. Augmented-reality goggle-based near-infrared fluorescence imaging with ICG is used to visualize and mark candidate sentinel lymph nodes. Intraoperative near-infrared imaging may be performed by an observer who is not the operating surgeon, solely to assess device performance; observer findings are not communicated to the operating surgeon before wound closure and do not influence the operation. All marked nodes and removed tissue undergo histopathology, which serves as the blinded reference standard. Device performance is assessed on consecutive eligible patients within defined enrollment windows; for each near-infrared imaging device, sensitivity, specificity, positive and negative predictive value, and node-level ROC analysis are estimated against final histopathology, with confidence intervals accounting for clustering of nodes within patients. The study is non-interventional: the imaging does not alter surgical management.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

AR-ICG near-infrared fluorescence imaging

Device

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.

Primary outcomes

  1. Node-level diagnostic accuracy of AR-ICG fluorescence imaging versus histopathology

    Time frame: From surgery to final histopathology (up to ~2 weeks after surgery)

    Sensitivity, specificity, positive and negative predictive value, and area under the ROC curve for goggle-based near-infrared fluorescence detection of tumor-positive lymph nodes, using final histopathology as the reference standard, with confidence intervals accounting for clustering of nodes within patients.

Secondary outcomes

  1. Patient-level sentinel-node detection rate

    Time frame: Final histopathology (up to approximately 2 weeks after surgery)

    Proportion of patients in whom at least one sentinel lymph node is identified by AR-ICG near-infrared fluorescence imaging.

  2. Concordance of device-marked nodes with histopathology

    Time frame: Final histopathology (up to approximately 2 weeks after surgery)

    Agreement between lymph nodes marked by AR-ICG fluorescence imaging and nodal status confirmed on final histopathology.

  3. Per-device diagnostic performance across near-infrared imaging systems

    Time frame: Through study completion (up to approximately 24 months)

    Sensitivity, specificity, positive predictive value, negative predictive value, and area under the ROC curve estimated separately for each near-infrared imaging device evaluated, using final histopathology as the reference standard, on consecutive eligible patients within defined enrollment windows.

  4. False-negative rate of AR-ICG fluorescence node detection

    Time frame: Final histopathology (up to approximately 2 weeks after surgery)

    Proportion of pathology-confirmed tumor-positive lymph nodes not identified as fluorescent by AR-ICG imaging.

  5. Number of candidate sentinel nodes identified per patient

    Time frame: Intraoperative (day of surgery)

    Number of candidate sentinel lymph nodes marked by AR-ICG fluorescence imaging per patient (count).

Study contacts

Contact information is provided by the study sponsor or research team.

Borislav Kondov, MD

CONTACT

[email protected]

+38972539003

Magdalena Bogdanovska Todorovska, MD

CONTACT

[email protected]

+389709602221

Sponsors and collaborators

Lead sponsor

Ss. Cyril and Methodius University of Skopje

Other

Collaborators

  • University of Illinois at Urbana-Champaign

Registry information

Official study title

Validation of Augmented-Reality/Virtual-Reality Goggle-Based Near-Infrared Fluorescence Imaging for Sentinel Lymph Node Detection in Patients With Breast Cancer

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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