[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ss. Cyril and Methodius University of Skopje\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":114},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"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":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28,29,30],"Breast Cancer","Breast Neoplasms","Sentinel Lymph Node","Lymphatic Metastasis",[32,33,34,35,36,37,38,39],"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":43,"type":44},"2026-07-10","ACTUAL",{"date":43,"type":21},{"date":47,"type":21},"2027-12-31",{"name":49,"class":50},"Ss. Cyril and Methodius University of Skopje","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":51},"100646887","device-validation-of-augmented-reality-icg-fluorescence-imaging-for-sentinel-lymph-node-detection-in-breast-cancer-100646887","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",{"count":60,"type":21},200,"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.",[27,28,29,30],[32,33,35,65,66,67],"sentinel lymph node biopsy","diagnostic accuracy","medical device validation","2026-06-28",{"date":41,"type":44},{"date":71,"type":21},"2026-07-01",{"date":73,"type":21},"2028-12-31",{"name":49,"class":50},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":82,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":94,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":111,"leadSponsor":113,"locationsCount":51},"100640349","niraf-guided-parathyroid-identification-during-thyroidectomy-100640349","NCT07617584","NIRAF-Guided Parathyroid Identification During Thyroidectomy","Near-Infrared Autofluorescence-Guided Parathyroid Identification During Thyroidectomy","Inclusion Criteria:\n\n* Age 18 years or older.\n* For Component A: planned thyroidectomy of any extent with an intact specimen available for ex vivo evaluation.\n* For Component B: planned total or completion thyroidectomy.\n* Ability to provide written informed consent before surgery.\n* Willingness to comply with routine postoperative laboratory testing and follow-up when feasible.\n\nExclusion Criteria:\n\n* Known pre-existing hypoparathyroidism or prior parathyroid surgery.\n* Severe chronic kidney disease or end-stage renal disease expected to substantially confound calcium and parathyroid hormone interpretation, as defined by the site investigator.\n* Pregnancy.\n* For Component B only: gross nodal disease or a surgical plan requiring extensive nodal packet dissection in the current study phase.\n* Any condition that, in the judgment of the investigator, would make participation unsafe or compromise protocol adherence.","ALL",{"count":84,"type":21},280,[24],"This is a single-site, two-component prospective study evaluating whether near-infrared autofluorescence (NIRAF) imaging can improve intraoperative identification of parathyroid glands during thyroidectomy and reduce postoperative hypocalcemia.\n\nThe investigational platform is a modified wearable stereoscopic goggle system configured for label-free NIRAF imaging. Parathyroid tissue is excited with near-infrared light at approximately 780 nm and emits autofluorescence centered near 800 nm. No injected dye or external contrast agent is used. The goggles are used only during a brief mapping interval after thyroid exposure and for ex vivo interrogation of the resected thyroid specimen.\n\nComponent A is a prospective observational run-in validation cohort of 30 adults undergoing thyroidectomy of any extent. NIRAF-positive foci on the intact thyroidectomy specimen are suture-marked and correlated with targeted pathology.\n\nComponent B is a randomized clinical study of 250 adults undergoing total or completion thyroidectomy. Participants are randomized 1:1 to standard surgery or standard surgery plus brief in vivo NIRAF mapping, ex vivo specimen interrogation, and rescue autotransplantation when indicated. The primary outcome for Component B is transient biochemical hypocalcemia on postoperative day 1, defined using albumin-corrected serum calcium.",[88,89,90,91,92,93],"Hypocalcemia","Hypoparathyroidism","Thyroid Diseases","Goiter, Nodular","Thyroid Nodule","Thyroidectomy",[95,96,97,98,93,99,100,101,102,103,104,105,106],"Near-Infrared Autofluorescence","NIRAF","Parathyroid Identification","Parathyroid Preservation","Completion Thyroidectomy","Total Thyroidectomy","Postoperative Hypocalcemia","Intact Parathyroid Hormone","iPTH","Rescue Autotransplantation","Wearable Imaging","Post-thyroidectomy hypocalcemia","2026-05-29",{"date":109,"type":44},"2026-06-01",{"date":109,"type":21},{"date":112,"type":21},"2029-12-01",{"name":49,"class":50},""]