[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596250":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":37,"locations":43,"responsibleParty":63,"collaborators":27,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":27,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":97,"whyStopped":27,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Fujian Medical University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A - Rim Preservation","EXPERIMENTAL","Participants undergo adenoma removal guided by PTS imaging, with deliberate preservation of the NIR-autofluorescent rim of normal parathyroid tissue.",[13,14],"Device: Near-Infrared Parathyroid Tissue Sensor Imaging (PTS)","Procedure: Rim-Preservation Technique",{"label":16,"type":17,"description":18,"interventionNames":19},"Arm B - En-bloc Resection","ACTIVE_COMPARATOR","Participants undergo PTS-guided en-bloc excision of the adenoma plus its NIR-positive rim; parathyroid autotransplantation performed when indicated.",[13,20],"Procedure: En-bloc Resection Technique",[22,28,33],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","Near-Infrared Parathyroid Tissue Sensor Imaging (PTS)","FDA-cleared imager (e.g., Fluobeam LX\u002FPTeye) providing real-time autofluorescence to identify parathyroid tissue during surgery; no dye or radiation.",[9,16],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"PROCEDURE","Rim-Preservation Technique","Surgical excision of adenoma while leaving the NIRAF-positive rim of normal parathyroid tissue in situ; minimal defatting to ensure perfusion.",[9],{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"En-bloc Resection Technique","Surgical excision of adenoma together with the surrounding NIRAF-positive rim; autotransplant fragment if \\\u003C 2 normal glands remain in neck.",[16],[38],{"name":39,"role":40,"phone":41,"phoneExt":27,"email":42},"Bo Wang Professor, MD","CONTACT","+13959123550","wangbo@fjmu.edu.cn",[44],{"facility":45,"status":27,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Fujian Medical University Union Hospital","Fuzhou","Fujian","350001","China","CN",{"type":52,"coordinates":53},"Point",[54,55],119.30611,26.06139,{"lat":55,"lon":54},[58,60],{"name":59,"role":40,"phone":41,"phoneExt":27,"email":42},"Bo Wang Porfessor, MD",{"name":61,"role":62,"phone":27,"phoneExt":27,"email":27},"Bo Wang MD, Principal Investigator","PRINCIPAL_INVESTIGATOR",{"type":62,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":45,"oldNameTitle":27,"oldOrganization":27},"Bo Wang,MD","Director & Head of Thyroid Surgery, Principal Investigator, Clinical Professor","100596250","white-cap-intra-operative-parathyroid-tissue-sensor-pts-guided-assessment-of-parathyroid-viability-and-surgical-decision-making-100596250",false,"NCT07043010","WHITE CAP: Intra-operative Parathyroid Tissue Sensor (PTS)-Guided Assessment of Parathyroid Viability and Surgical Decision-Making","WHITE CAP Trial: Optical Parathyroid Tissue Sensor-Guided Assessment of Parathyroid Viability and Its Impact on Clinical Decision-Making","WHITE CAP-PTS","Inclusion Criteria:\n\n* Age 18 to 75 years, able to give informed consent.\n* Biochemically proven primary hyperparathyroidism (elevated serum calcium and inappropriately high PTH).\n* Pre-operative imaging (sestamibi scan, 4-phase CT, or ultrasound) concordant with a single parathyroid adenoma.\n* Planned minimally invasive parathyroidectomy using near-infrared parathyroid tissue sensor (PTS) guidance.\n\nExclusion Criteria:\n\n* Multiple endocrine neoplasia (MEN 1 or 2) or suspicion of multi-gland disease (\\>1 enlarged gland on imaging).\n* Prior parathyroid or extensive neck surgery causing distorted anatomy.\n* Need for simultaneous total thyroidectomy or other major neck procedure.\n* Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m².\n* Pregnancy or breastfeeding.\n* Inability to tolerate general anaesthesia or contraindication to intra-operative PTS imaging.","ALL","18 Years","75 Years",{"count":78,"type":79},120,"ESTIMATED","INTERVENTIONAL",[82],"NA","Primary hyperparathyroidism is usually cured by removing the single over-active parathyroid adenoma. During surgery, however, surgeons often see a thin rim of normal parathyroid tissue that still \"glows\" under a near-infrared parathyroid tissue sensor (PTS). It is unclear whether keeping this tissue in place helps preserve hormone function or whether it leaves behind cells that could become over-active again.\n\nThe WHITE CAP study will compare two common surgical choices:\n\nPreservation strategy - the surgeon removes only the adenoma and leaves the glowing rim of normal tissue untouched.\n\nEn-bloc strategy - the surgeon removes the adenoma together with the glowing rim; if too little parathyroid tissue remains, a small fragment is transplanted into the forearm muscle.\n\nAbout 120 adult patients who have a single parathyroid adenoma will be randomly assigned (like tossing a coin) to one of the two strategies. All operations will use the same FDA-cleared PTS camera that shows the glands in real time without dye or radiation.\n\nThe main question is whether preserving the normal rim lowers the rate of temporary low blood-calcium (numbness, tingling) during the first two days after surgery. The study will also check long-term results-blood calcium and parathyroid hormone (PTH) levels, symptoms, and any return of the disease-over two years.\n\nThe PTS imaging itself is painless and adds only a few minutes to the operation. Risks are the same as for standard parathyroid surgery, and participants can withdraw at any time without affecting their usual care.",[85,86,87,88],"Hyperparathyroidism, Primary","Parathyroid Neoplasms","Parathyroid Adenoma","Hypocalcemia",[90,91,92,93,94,95,96],"Near-Infrared Autofluorescence","Parathyroid Tissue Sensor","Parathyroid Viability","Peri-adenoma Rim Preservation","Intra-operative Imaging","Calcium Homeostasis","PTS Camera","NOT_YET_RECRUITING","2025-06-27",{"date":100,"type":101},"2025-06-29","ACTUAL",{"date":103,"type":79},"2025-07-01",{"date":105,"type":79},"2029-12-31",{"name":5,"class":6},1]