[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646887":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":30,"responsibleParty":45,"collaborators":49,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":10,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":10,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":71,"overallStatus":78,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Ss. Cyril and Methodius University of Skopje","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Breast cancer patients undergoing surgery with AR-ICG node imaging",null,"Patients undergoing breast cancer surgery in whom AR-ICG goggle-based near-infrared imaging is used to mark candidate sentinel nodes, with optional observer near-infrared imaging for device-performance assessment; histopathology is the reference standard.",[13],"Device: AR-ICG near-infrared fluorescence imaging",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"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.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Borislav Kondov, MD","CONTACT","+38972539003","borislav.kondov@medf.ukim.edu.mk",{"name":27,"role":23,"phone":28,"phoneExt":10,"email":29},"Magdalena Bogdanovska Todorovska, MD","+389709602221","magdalena.todorovska@medf.ukim.edu.mk",[31],{"facility":32,"status":10,"city":33,"state":10,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"University Clinic for Thoracic and Vascular Surgery, Faculty of Medicine, UKIM","Skopje","1000","North Macedonia","MK",{"type":38,"coordinates":39},"Point",[40,41],21.43141,41.99646,{"lat":41,"lon":40},[44],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Borislav Kondov","Professor \u002F Principal Investigator",[50],{"name":51,"class":6},"University of Illinois at Urbana-Champaign","100646887","device-validation-of-augmented-reality-icg-fluorescence-imaging-for-sentinel-lymph-node-detection-in-breast-cancer-100646887",false,"NCT07683572","Device Validation of Augmented-Reality ICG Fluorescence Imaging for Sentinel Lymph Node Detection in Breast Cancer","Validation of Augmented-Reality\u002FVirtual-Reality Goggle-Based Near-Infrared Fluorescence Imaging for Sentinel Lymph Node Detection in Patients With Breast Cancer","Inclusion Criteria:\n\n* Histologically proven breast cancer\n* Age 18 years or older\n* Undergoing breast cancer surgery with sentinel lymph node evaluation and\u002For axillary lymph node dissection\n* Provides written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Neoadjuvant chemotherapy\n* Prior breast surgery\n* Iodine or seafood allergy\n* Indocyanine green (ICG) allergy\n* Declines or is unable to provide informed consent","FEMALE","18 Years",{"count":62,"type":63},200,"ESTIMATED","OBSERVATIONAL","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.",[67,68,69,70],"Breast Cancer","Breast Neoplasms","Sentinel Lymph Node","Lymphatic Metastasis",[72,73,74,75,76,77],"indocyanine green","near-infrared fluorescence","augmented reality","sentinel lymph node biopsy","diagnostic accuracy","medical device validation","NOT_YET_RECRUITING","2026-06-28",{"date":81,"type":82},"2026-07-06","ACTUAL",{"date":84,"type":63},"2026-07-01",{"date":86,"type":63},"2028-12-31",{"name":5,"class":6},1]