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.
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
Pregnancy
Neoadjuvant chemotherapy
Prior breast surgery
Iodine or seafood allergy
Patients with histologically proven breast cancer undergoing surgery with axillary lymph node evaluation at the participating center, enrolled consecutively.
Cohort
Prospective
AR-ICG near-infrared fluorescence imaging
DeviceAugmented-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.
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.
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.
Concordance of device-marked nodes with histopathology
Agreement between lymph nodes marked by AR-ICG fluorescence imaging and nodal status confirmed on final histopathology.
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.
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.
Click on the lead sponsor to view all of their trials.
Ss. Cyril and Methodius University of Skopje
Lead sponsor
University of Illinois at Urbana-Champaign
Collaborator
This trial is not recruiting at the moment. You can still explore other options: