[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646126":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":39,"studyPopulation":32,"armGroups":40,"interventions":47,"overallOfficials":32,"centralContacts":53,"locations":63,"responsibleParty":78,"collaborators":82,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":32,"enrollmentInfo":95,"targetDuration":32,"studyType":98,"phases":99,"briefSummary":100,"conditions":101,"keywords":106,"overallStatus":115,"whyStopped":32,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Ss. Cyril and Methodius University of Skopje","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Patient-level rate of clinically significant events (CSE)","Proportion of patients with at least one clinically significant event (CSE). A CSE is defined as additional fluorescent tissue identified at the second-look review after the surgeon's declared completion of the axillary dissection, not previously planned for removal, removed after re-assessment under standard lighting, and confirmed on final histopathology to be a lymph node containing tumor (isolated tumor cells, micrometastasis, or macrometastasis).","From intraoperative second-look review to final histopathology (up to approximately 2 weeks after surgery)",[14,18,22,25,28],{"measure":15,"description":16,"timeFrame":17},"Distribution of additional fluorescent findings by tissue category","Number of additional fluorescent findings classified on histopathology as tumor-positive lymph node, tumor-negative lymph node, or non-nodal tissue (e.g., fibro-adipose tissue or dye leakage).","Final histopathology (up to approximately 2 weeks after surgery)",{"measure":19,"description":20,"timeFrame":21},"Anatomic location of additional fluorescent findings","Anatomic location of each additional fluorescent finding, recorded as axillary level I, II, or III; interpectoral (Rotter); internal mammary; or other.","Intraoperative (day of surgery)",{"measure":23,"description":24,"timeFrame":17},"Nodal stage migration","Change in pathological nodal category (pN) before versus after inclusion of tissue removed at the second-look review.",{"measure":26,"description":27,"timeFrame":21},"Added operative time for the second-look review","Additional operative time required to perform the second-look review, in minutes.",{"measure":29,"description":30,"timeFrame":31},"Procedure- or device-related adverse events","Number of participants with adverse events related to the study procedure or device.","Through 30 days after surgery",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":38,"maskingDescription":32,"whoMasked":32},"NONE","Accurate axillary nodal staging is central to breast cancer management. During axillary lymph node dissection, some nodal tissue-particularly in the apical\u002Fhigh axilla-can remain after the operating surgeon considers the dissection complete. Near-infrared fluorescence imaging with indocyanine green (ICG) can highlight nodal tissue intraoperatively. This pilot evaluates a wearable augmented-reality imaging system that displays combined color and near-infrared information, used for a brief \"second-look\" examination after the surgeon has declared the axillary procedure complete.\n\nThis is a prospective, single-arm pilot in patients undergoing breast cancer surgery with complete axillary lymph node dissection. After the surgeon prospectively declares the axillary procedure complete, a short additional in vivo fluorescence review of the surgical field is performed. If additional fluorescent tissue is identified, it is re-assessed under standard operating-room lighting and removed only if the surgeon judges removal safe and clinically appropriate; goggle findings do not replace standard surgical judgment. Any tissue removed at the second-look is submitted separately for histopathology, and findings are classified by tissue type and anatomic location.\n\nThe study is exploratory and is not powered to demonstrate clinical benefit; it is intended to assess feasibility, safety, and an initial clinical signal to inform a larger study.",[41],{"label":42,"type":43,"description":44,"interventionNames":45},"AR-ICG Second-Look","EXPERIMENTAL","After the operating surgeon declares the axillary lymph node dissection complete, a brief augmented-reality ICG near-infrared fluorescence re-examination of the surgical field is performed. Additional fluorescent tissue is re-assessed under standard lighting and removed only if the surgeon judges removal safe and clinically appropriate; removed tissue undergoes separate histopathology.",[46],"Device: Augmented-reality ICG fluorescence second-look imaging",[48],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":32},"DEVICE","Augmented-reality ICG fluorescence second-look imaging","A wearable augmented-reality system displaying combined color and near-infrared fluorescence, with a handheld laser\u002Fwhite-light illuminator, used to re-examine the axillary field for residual ICG-fluorescent tissue after the surgeon declares the dissection complete. Indocyanine green is administered intraoperatively per protocol.",[42],[54,59],{"name":55,"role":56,"phone":57,"phoneExt":32,"email":58},"Borislav Kondov, MD","CONTACT","+38972539003","borislav.kondov@medf.ukim.edu.mk",{"name":60,"role":56,"phone":61,"phoneExt":32,"email":62},"Magdalena Bogdanovska Todorovska, MD","+389709602221","magdalena.todorovska@medf.ukim.edu.mk",[64],{"facility":65,"status":32,"city":66,"state":32,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"University Clinic for Thoracic and Vascular Surgery, Faculty of Medicine, UKIM","Skopje","1000","North Macedonia","MK",{"type":71,"coordinates":72},"Point",[73,74],21.43141,41.99646,{"lat":74,"lon":73},[77],{"name":55,"role":56,"phone":57,"phoneExt":32,"email":58},{"type":79,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Borislav Kondov","Professor \u002F Principal Investigator",[83],{"name":84,"class":6},"University of Illinois at Urbana-Champaign","100646126","augmented-reality-icg-fluorescence-second-look-for-residual-nodal-disease-after-axillary-dissection-in-breast-cancer-100646126",false,"NCT07696754","Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer","Mapping of Lymph Nodes Using Augmented-reality\u002FVirtual-reality Goggles in Patients With Breast Cancer","AR4SLN","Inclusion Criteria:\n\n* Histologically proven breast cancer\n* Age 18 years or older\n* Undergoing radical surgery (mastectomy or quadrantectomy) with complete 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":96,"type":97},30,"ESTIMATED","INTERVENTIONAL",[34],"This study tests whether special imaging goggles can help surgeons find lymph nodes that may be left behind during breast cancer surgery. The goggles show a fluorescent dye (indocyanine green, ICG) that is given during the operation and collects in lymph nodes.\n\nIn breast cancer surgery, the surgeon removes lymph nodes from the armpit (axilla) to check whether the cancer has spread. Some nodes can be difficult to see and may remain after the surgeon believes the removal is complete. This study looks at whether the goggles can reveal such remaining nodes after the surgeon has declared the axillary surgery finished.\n\nThirty patients having breast cancer surgery with removal of the axillary lymph nodes will take part. After the surgeon states the planned removal is complete, the surgeon will briefly re-examine the area using the goggles and the ICG signal. If additional glowing tissue is seen, the surgeon will decide-using normal surgical judgment-whether it is safe and appropriate to remove it. Any tissue removed this way is examined under the microscope to determine whether it is a lymph node and whether it contains cancer.\n\nThe study measures how often this additional examination finds cancer-containing nodes that would otherwise have remained, where these nodes are located, whether the finding changes the cancer stage, and how much extra time the examination takes. The study also records any side effects. The results will help determine whether this approach should be studied in a larger trial.",[102,103,104,105],"Breast Cancer","Breast Neoplasms","Sentinel Lymph Node","Lymphatic Metastasis",[107,108,109,110,111,112,113,114],"indocyanine green","near-infrared fluorescence","fluorescence-guided surgery","augmented reality","axillary lymph node dissection","residual nodal disease","sentinel lymph node","breast cancer","NOT_YET_RECRUITING","2026-07-06",{"date":118,"type":119},"2026-07-10","ACTUAL",{"date":118,"type":97},{"date":122,"type":97},"2027-12-31",{"name":5,"class":6},1]