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

May 14, 2026 updated by: National Taiwan University Hospital

Application of Extended Reality (XR)-Assisted PET/CT Fusion Navigation in Supraclavicular-to-Cervical Lymph Node Dissection for Lung Cancer

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background and Rationale NSCLC with supraclavicular or cervical lymph node metastasis (N3 disease) was historically considered unresectable. With the advance of multimodal therapy, complete lymph node dissection in selected patients has been shown to improve locoregional control. However, the supraclavicular fossa - frequently described as 'Pandora's Box' - is anatomically narrow and dense, with metastatic nodes often abutting the subclavian vessels, internal jugular vein, phrenic nerve, and brachial plexus. Conventional surgery relies heavily on the surgeon's tactile experience and 2D mental reconstruction of preoperative CT, increasing the risk of inadvertent neurovascular injury and incomplete clearance of post-treatment fibrotic versus active disease.

Intervention This study integrates two complementary technologies. (1) Multimodal image fusion using Fujifilm Synapse 3D maps PET SUV hotspots representing biologically active tumor onto a high-resolution CT anatomical model, producing a patient-specific digital twin. The fused model is exported to a static 3D format (OBJ/STL) and imported into the OpVerse XR platform - an offline data-conversion workflow with no real-time API coupling between the two systems, ensuring system stability and software compatibility. (2) Preoperative XR planning: in the operating room after general anesthesia and head/neck positioning, the surgeon wears an XR head-mounted display (HoloLens) and performs surface registration using stable bony landmarks. The 'see-through' overlay enables the surgeon to identify subcutaneous tumor hotspots and superficial venous anatomy, and to mark the optimal skin incision and initial dissection trajectory before any cut is made. The XR headset is then removed; lymph node dissection proceeds using standard sterile technique. Therefore the device functions purely as a preoperative visual aid (Non-Significant Risk), without entry into the sterile operative field.

Lymph node dissection definition En bloc systematic resection of the fibrofatty tissue containing metastatic nodes within the defined cervical or supraclavicular region, to achieve oncologic clearance and provide adequate tissue for pathologic staging and next-generation sequencing.

Statistical analysis All analyses are performed using SPSS. Continuous variables (operative time, blood loss, lymph node count) are summarized as mean ± SD or median; categorical variables (complications, registration success) as frequency and percentage. Successful completion rate of the XR-assisted workflow is reported with 95% confidence intervals. As a single-arm feasibility trial, no formal hypothesis testing is planned.

Preliminary data The investigators have completed a prior pilot trial (REC 202502149RINB, 2025) of XR-assisted lung nodule localization in 20 patients undergoing thoracoscopic sublobar resection, achieving 6-7 mm mean target registration error and 19/20 successful localizations without major complications. Because the supraclavicular region is more rigidly tethered to the bony skeleton and less affected by respiratory motion, registration accuracy in the present study is expected to be ≤5 mm.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XR-Assisted Surgical Planning
Patients undergo XR-assisted preoperative incision planning using the OpVerse platform with HoloLens HMD, overlaying a PET/CT-fused 3D digital twin onto the patient's neck before skin incision. The XR device is then removed, and standard cervical/supraclavicular lymph node dissection is performed without intraoperative XR guidance.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful Completion of XR-Assisted Preoperative Surgical Planning Workflow
Time Frame: Intraoperatively, prior to skin incision (Day 0)

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.
Intraoperatively, prior to skin incision (Day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Procedure-Related Adverse Events
Time Frame: From surgery through 30 days postoperatively
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.
From surgery through 30 days postoperatively
Surgeon-Assessed Adequacy of XR-Planned Surgical Incision (3-Point Categorical Scale)
Time Frame: Intraoperatively, at time of skin incision and during initial dissection (Day 0)

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.
Intraoperatively, at time of skin incision and during initial dissection (Day 0)
PET Hotspot Clearance Rate
Time Frame: At time of surgery
Proportion of preoperatively identified PET-positive lymph nodes (SUV hotspots) that are completely resected, confirmed by review of the operative specimen against preoperative imaging.
At time of surgery
Target Registration Error (TRE)
Time Frame: At time of surgery
Mean spatial offset (millimeters) between virtual model bony landmarks and corresponding patient anatomy after XR surface registration.
At time of surgery
Operative Time
Time Frame: At time of surgery
Total time from skin incision to skin closure (minutes).
At time of surgery
Estimated Intraoperative Blood Loss
Time Frame: At time of surgery
Volume of blood loss recorded during the procedure (milliliters).
At time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Jin-Shing Chen, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

May 10, 2026

First Submitted That Met QC Criteria

May 14, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202602094DINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared outside the investigator team during this feasibility study. De-identified aggregate results will be reported in peer-reviewed publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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