[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639876":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":31,"locations":21,"responsibleParty":38,"collaborators":21,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":21,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":71,"whyStopped":21,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":21},{"fullName":5,"class":6},"National Taiwan University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"XR-Assisted Surgical Planning","EXPERIMENTAL","Patients undergo XR-assisted preoperative incision planning using the OpVerse platform with HoloLens HMD, overlaying a PET\u002FCT-fused 3D digital twin onto the patient's neck before skin incision. The XR device is then removed, and standard cervical\u002Fsupraclavicular lymph node dissection is performed without intraoperative XR guidance.",[13,14],"Device: OpVerse XR Surgical Planning Platform with HoloLens HMD","Procedure: Cervical \u002F Supraclavicular Lymph Node Dissection",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DEVICE","OpVerse XR Surgical Planning Platform with HoloLens HMD","An offline workflow in which patient-specific PET\u002FCT-fused 3D models built in Synapse 3D are exported to OBJ\u002FSTL format and rendered via the OpVerse platform on a HoloLens head-mounted display. The surgeon performs surface registration to bony landmarks of the neck and shoulder for preoperative incision planning. The device is removed prior to skin incision and is not used during the sterile dissection.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"PROCEDURE","Cervical \u002F Supraclavicular Lymph Node Dissection","En bloc systematic resection of fibrofatty tissue and metastatic lymph nodes within the cervical or supraclavicular region, performed using standard open surgical technique after XR-assisted incision planning.",[9],[28],{"name":29,"affiliation":5,"role":30},"Jin-Shing Chen","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Chih-Hsiang Chang","CONTACT","+886-2-2312-3456","53384","changch1986@ntuh.gov.tw",{"type":39,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100639876","xr-assisted-petct-navigation-for-cervical-lymph-node-dissection-in-lung-cancer-100639876",false,"NCT07593872","XR-Assisted PET\u002FCT Navigation for Cervical Lymph Node Dissection in Lung Cancer","Application of Extended Reality (XR)-Assisted PET\u002FCT Fusion Navigation in Supraclavicular-to-Cervical Lymph Node Dissection for Lung Cancer","XR-NeckLND","Inclusion Criteria:\n\n* Age 18 to 80 years.\n* Confirmed or highly suspected lung cancer with supraclavicular or cervical lymph node metastasis requiring lymph node dissection.\n* Willing to undergo preoperative PET\u002FCT imaging.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Prior high-dose radiation therapy to the neck causing severe distortion of cervical anatomy.\n* Inability to undergo imaging studies, or known allergy to iodinated contrast media.\n* Vulnerable populations as defined by local IRB regulations (e.g., pregnant women, prisoners, individuals lacking decisional capacity).","ALL","18 Years","80 Years",{"count":52,"type":53},10,"ESTIMATED","INTERVENTIONAL",[56],"NA","This single-arm, prospective feasibility study evaluates an Extended Reality (XR) headset-based preoperative surgical planning workflow that fuses 18F-FDG PET metabolic hotspots with CT anatomy on the OpVerse platform, in patients with non-small cell lung cancer (NSCLC) and supraclavicular or cervical lymph node metastasis (N3 disease) requiring lymph node dissection. Ten participants will undergo standard preoperative contrast-enhanced CT and whole-body PET. Synapse 3D software is used to segment key anatomic structures (clavicle, sternocleidomastoid, internal jugular vein, subclavian vessels, brachial plexus) and to project PET SUV hotspots onto the high-resolution CT model, yielding a patient-specific digital twin of functional tumor boundaries and at-risk neurovascular structures.\n\nImmediately prior to skin incision, the operating surgeon dons an XR head-mounted display (HoloLens via OpVerse) and registers the digital twin to the patient's neck using stable bony landmarks (clavicular head, sternal notch, mastoid). The surgeon plans the optimal incision and initial dissection trajectory, avoiding superficial veins and projecting the location of deep PET-positive nodes. The XR device is then removed, and the planned cervical or supraclavicular lymph node dissection is performed using standard surgical technique without further intraoperative XR guidance.\n\nThe primary endpoint is a composite of safety and feasibility: absence of Grade ≥2 (Clavien-Dindo) phrenic nerve, brachial plexus, chyle leak, Horner syndrome, or major vascular injury through 30 days postoperatively, together with successful XR registration and incision planning. Secondary endpoints include incision planning accuracy, PET hotspot clearance rate, target registration error, operative time, estimated blood loss, and lymph node yield.",[59,60,61],"Non-Small Cell Lung Cancer","Lymph Node Metastasis","Supraclavicular Lymph Node Metastasis",[63,64,65,66,67,68,69,70],"Extended Reality","Augmented Reality","Surgical Navigation","PET\u002FCT Fusion","Image-Guided Surgery","Digital Twin","Lymph Node Dissection","Mixed Reality","NOT_YET_RECRUITING","2026-05-14",{"date":74,"type":75},"2026-05-18","ACTUAL",{"date":77,"type":53},"2026-06-01",{"date":79,"type":53},"2027-04-01",{"name":5,"class":6}]