XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNational Taiwan University Hospital
About this trial
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.
Immediately 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.
The 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 to 80 years.
Confirmed or highly suspected lung cancer with supraclavicular or cervical lymph node metastasis requiring lymph node dissection.
Willing to undergo preoperative PET/CT imaging.
Able to provide written informed consent.
Disqualifiers
Prior high-dose radiation therapy to the neck causing severe distortion of cervical anatomy.
Inability to undergo imaging studies, or known allergy to iodinated contrast media.
Vulnerable populations as defined by local IRB regulations (e.g., pregnant women, prisoners, individuals lacking decisional capacity).
Trial design
Design model
Single group
Treatments tested in this trial
OpVerse XR Surgical Planning Platform with HoloLens HMD
DeviceAn offline workflow in which patient-specific PET/CT-fused 3D models built in Synapse 3D are exported to OBJ/STL 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.
Cervical / Supraclavicular Lymph Node Dissection
Procedure/SurgeryEn 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: XR-Assisted Surgical PlanningExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Successful Completion of XR-Assisted Preoperative Surgical Planning Workflow
Proportion of participants in whom the complete XR-assisted preoperative planning workflow is successfully executed, defined as meeting ALL of the following technical criteria: 1. Successful import and rendering of the patient-specific PET/CT fused 3D digital twin (OBJ/STL format) on the OpVerse platform via the HoloLens head-mounted display. 2. Successful surface registration to the patient's bony landmarks (clavicular head, sternal notch, mastoid) with a Target Registration Error (TRE) of 5 mm or less. 3. Successful surgeon-performed marking of the optimal skin incision and initial dissection trajectory prior to skin incision. The endpoint is reported as the percentage of cases (out of 10) meeting all three criteria.
Time frame
Intraoperatively, prior to skin incision (Day 0)Secondary outcomes
1
Incidence of Procedure-Related Adverse Events
Proportion of participants experiencing Grade ≥2 (Clavien-Dindo classification) adverse events related to the surgical procedure, including phrenic nerve injury, brachial plexus injury, chyle leak, Horner syndrome, or major vascular injury.
Time frame
From surgery through 30 days postoperatively2
Surgeon-Assessed Adequacy of XR-Planned Surgical Incision (3-Point Categorical Scale)
Adequacy of the XR-planned skin incision in exposing the targeted lymph nodes, assessed intraoperatively by the operating surgeon using a 3-point categorical scale: * Grade 1 (Adequate): the planned incision provides sufficient exposure of all targeted lymph nodes; no modification required. * Grade 2 (Minor modification): the planned incision requires extension of 2 cm or less to achieve adequate exposure. * Grade 3 (Major modification): the planned incision requires extension of more than 2 cm, or repositioning to a different skin site, to achieve adequate exposure. The endpoint is reported as the proportion of cases (out of 10) in each grade.
Time frame
Intraoperatively, at time of skin incision and during initial dissection (Day 0)3
PET Hotspot Clearance Rate
Proportion of preoperatively identified PET-positive lymph nodes (SUV hotspots) that are completely resected, confirmed by review of the operative specimen against preoperative imaging.
Time frame
At time of surgery4
Target Registration Error (TRE)
Mean spatial offset (millimeters) between virtual model bony landmarks and corresponding patient anatomy after XR surface registration.
Time frame
At time of surgeryLocations
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Source ClinicalTrials.gov
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