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

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.

Conditions

• Non-Small Cell Lung Cancer
• Lymph Node Metastasis
• Supraclavicular Lymph Node Metastasis

Interventions

DEVICE

OpVerse XR Surgical Planning Platform with HoloLens HMD

An 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.

PROCEDURE

Cervical / 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.

Sponsors & Collaborators

• National Taiwan University Hospital

  lead OTHER

Principal Investigators

• Jin-Shing Chen · National Taiwan University Hospital

Study Design

Allocation

NA

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2027-04-01

Completion

2027-04-01