[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640349":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":57,"collaborators":60,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":12,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":12,"enrollmentInfo":72,"targetDuration":12,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":86,"overallStatus":99,"whyStopped":12,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Ss. Cyril and Methodius University of Skopje","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Thyroidectomy","NO_INTERVENTION","Participants undergo standard thyroidectomy under white light and routine surgical judgment. Conventional autotransplantation remains permitted if the surgeon identifies a devascularized or inadvertently excised parathyroid gland by standard methods.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Standard Thyroidectomy Plus NIRAF-Guided Parathyroid Mapping","EXPERIMENTAL","Participants undergo standard thyroidectomy plus a defined interval of in vivo near-infrared autofluorescence (NIRAF) mapping after thyroid exposure and ex vivo interrogation of the resected thyroid specimen. Rescue autotransplantation may be performed when a NIRAF-bright focus on the specimen is judged likely to represent parathyroid tissue and meets predefined oncologic safety criteria.",[18],"Device: Wearable Near-Infrared Autofluorescence Imaging System",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DEVICE","Wearable Near-Infrared Autofluorescence Imaging System","A modified Meta head-mounted stereoscopic goggle system configured for label-free near-infrared autofluorescence imaging. The system delivers near-infrared excitation at approximately 780 nm and detects parathyroid autofluorescence centered near 800 nm. No injected dye or external contrast agent is administered. The device is used briefly after thyroid exposure for in vivo mapping and after thyroid resection for ex vivo specimen interrogation.",[14],[26],{"name":27,"affiliation":5,"role":28},"Magdalena Bogdanovska Todorovska, MD, PhD","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":12,"email":33},"CONTACT","+389-70960221","magdalena.todorovska@medf.ukim.edu.mk",{"name":35,"role":31,"phone":36,"phoneExt":12,"email":37},"Borislav Kondov, MD, PhD","+389.72539003","borislav.kondov@medf.ukim.edu.mk",[39],{"facility":40,"status":12,"city":41,"state":12,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"University Clinic Hospital","Skopje","1000","North Macedonia","MK",{"type":46,"coordinates":47},"Point",[48,49],21.43141,41.99646,{"lat":49,"lon":48},[52,54,55],{"name":27,"role":31,"phone":53,"phoneExt":12,"email":33},"+389.70.960221",{"name":27,"role":28,"phone":12,"phoneExt":12,"email":12},{"name":35,"role":56,"phone":12,"phoneExt":12,"email":12},"SUB_INVESTIGATOR",{"type":28,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Prof. Magdalena Bogdanovska Todorovska","Professor and Principal Investigator",[61],{"name":62,"class":6},"University of Illinois at Urbana-Champaign","100640349","niraf-guided-parathyroid-identification-during-thyroidectomy-100640349",false,"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","18 Years",{"count":73,"type":74},280,"ESTIMATED","INTERVENTIONAL",[77],"NA","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.",[80,81,82,83,84,85],"Hypocalcemia","Hypoparathyroidism","Thyroid Diseases","Goiter, Nodular","Thyroid Nodule","Thyroidectomy",[87,88,89,90,85,91,92,93,94,95,96,97,98],"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","NOT_YET_RECRUITING","2026-05-29",{"date":102,"type":103},"2026-06-01","ACTUAL",{"date":102,"type":74},{"date":106,"type":74},"2029-12-01",{"name":5,"class":6},1]