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Clinical Trial

XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer

NCT: NCT07593872 · NOT_YET_RECRUITING

NCT IDNCT07593872
StatusNOT_YET_RECRUITING
Start Date2026-06-01
Completion2027-04-01

Brief Summary

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.

Frequently Asked Questions

What is XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer?

XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer is a clinical trial registered under NCT07593872. Current status: NOT_YET_RECRUITING.

What is the status of NCT07593872?

The current status of NCT07593872 (XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer) is: NOT_YET_RECRUITING.

When did XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer start?

XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer started on 2026-06-01.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.