NCT07593872Not yet recruiting
XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer
Application of Extended Reality (XR)-Assisted PET/CT Fusion Navigation in Supraclavicular-to-Cervical Lymph Node Dissection for Lung Cancer
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 10 May 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07593872
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 1 Jun 2026 to the primary completion date, 1 Apr 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior high-dose radiation therapy to the neck causing severe distortion of cervical anatomy.
Other illness
- Inability to undergo imaging studies, or known allergy to iodinated contrast media.
Other
- Vulnerable populations as defined by local IRB regulations (e.g., pregnant women, prisoners, individuals lacking decisional capacity).
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.