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.
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.
Study Type
OBSERVATIONAL
Enrollment
200
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.
University Clinic for Thoracic and Vascular Surgery, Faculty of Medicine, UKIM
Skopje, North Macedonia
Node-level diagnostic accuracy of AR-ICG fluorescence imaging versus histopathology
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.
Time frame: From surgery to final histopathology (up to ~2 weeks after surgery)
Patient-level sentinel-node detection rate
Proportion of patients in whom at least one sentinel lymph node is identified by AR-ICG near-infrared fluorescence imaging.
Time frame: Final histopathology (up to approximately 2 weeks after surgery)
Concordance of device-marked nodes with histopathology
Agreement between lymph nodes marked by AR-ICG fluorescence imaging and nodal status confirmed on final histopathology.
Time frame: Final histopathology (up to approximately 2 weeks after surgery)
Per-device diagnostic performance across near-infrared imaging systems
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.
Time frame: Through study completion (up to approximately 24 months)
False-negative rate of AR-ICG fluorescence node detection
Proportion of pathology-confirmed tumor-positive lymph nodes not identified as fluorescent by AR-ICG imaging.
Time frame: Final histopathology (up to approximately 2 weeks after surgery)
Number of candidate sentinel nodes identified per patient
Number of candidate sentinel lymph nodes marked by AR-ICG fluorescence imaging per patient (count).
Time frame: Intraoperative (day of surgery)
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