Non-Small Cell Lung CancerXR-NeckLNDNCT07593872
XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer
A study testing OpVerse XR Surgical Planning Platform with HoloLens HMD and Cervical / Supraclavicular Lymph Node Dissection in people with Non-Small Cell Lung Cancer and Lymph Node Metastasis, run by National Taiwan University Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Small Cell Lung Cancer, Lymph Node Metastasis, Supraclavicular Lymph Node Metastasis
- What is being tested?
- OpVerse XR Surgical Planning Platform with HoloLens HMD and Cervical / Supraclavicular Lymph Node Dissection
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- OpVerse XR Surgical Planning Platform with HoloLens HMD, Cervical / Supraclavicular Lymph Node Dissection
- Keywords
- Extended Reality, Augmented Reality, Surgical Navigation, PET/CT Fusion, Image-Guided Surgery, Digital Twin, Lymph Node Dissection, Mixed Reality
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpVerse XR Surgical Planning Platform with HoloLens HMDDevice
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.
Cervical / Supraclavicular Lymph Node DissectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| XR-Assisted Surgical Planning | Experimental | 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. Receives: Device: OpVerse XR Surgical Planning Platform with HoloLens HMD; Procedure: Cervical / Supraclavicular Lymph Node Dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
- 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.
- 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.
Measured: Intraoperatively, prior to skin incision (Day 0)
Secondary outcomes (6)
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.
Measured: From surgery through 30 days postoperatively
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.
Measured: Intraoperatively, at time of skin incision and during initial dissection (Day 0)
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.
Measured: At time of surgery
Target Registration Error (TRE)
Mean spatial offset (millimeters) between virtual model bony landmarks and corresponding patient anatomy after XR surface registration.
Measured: At time of surgery
Operative Time
Total time from skin incision to skin closure (minutes).
Measured: At time of surgery
Estimated Intraoperative Blood Loss
Volume of blood loss recorded during the procedure (milliliters).
Measured: At time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin-Shing Chen, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593872
- Sponsor's protocol ID
- 202602094DINA
- Acronym
- XR-NeckLND
- Status last verified
- May 2026
- First submitted
- 10 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Ueda K, Tanaka T, Hayashi M, Tanaka N, Li TS, Hamano K. What proportion of lung cancers can be operated by segmentectomy? A computed-tomography-based simulation. Eur J Cardiothorac Surg. 2012 Feb;41(2):341-5. doi: 10.1016/j.ejcts.2011.05.034. Epub 2011 Dec 12.
PubMed 21703862Jensen K, Ringsted C, Hansen HJ, Petersen RH, Konge L. Simulation-based training for thoracoscopic lobectomy: a randomized controlled trial: virtual-reality versus black-box simulation. Surg Endosc. 2014 Jun;28(6):1821-9. doi: 10.1007/s00464-013-3392-7. Epub 2014 Jan 18.
PubMed 24442678Hu Y, Malthaner RA. The feasibility of three-dimensional displays of the thorax for preoperative planning in the surgical treatment of lung cancer. Eur J Cardiothorac Surg. 2007 Mar;31(3):506-11. doi: 10.1016/j.ejcts.2006.11.054. Epub 2007 Jan 16.
PubMed 17223351Bakhuis W, Sadeghi AH, Moes I, Maat APWM, Siregar S, Bogers AJJC, Mahtab EAF. Essential Surgical Plan Modifications After Virtual Reality Planning in 50 Consecutive Segmentectomies. Ann Thorac Surg. 2023 May;115(5):1247-1255. doi: 10.1016/j.athoracsur.2022.08.037. Epub 2022 Sep 6.
PubMed 36084694Sato M, Kobayashi M, Kojima F, Tanaka F, Yanagiya M, Kosaka S, Fukai R, Nakajima J. Effect of virtual-assisted lung mapping in acquisition of surgical margins in sublobar lung resection. J Thorac Cardiovasc Surg. 2018 Oct;156(4):1691-1701.e5. doi: 10.1016/j.jtcvs.2018.05.122. Epub 2018 Jul 20.
PubMed 30248803Sadeghi AH, Mathari SE, Abjigitova D, Maat APWM, Taverne YJHJ, Bogers AJJC, Mahtab EAF. Current and Future Applications of Virtual, Augmented, and Mixed Reality in Cardiothoracic Surgery. Ann Thorac Surg. 2022 Feb;113(2):681-691. doi: 10.1016/j.athoracsur.2020.11.030. Epub 2020 Dec 19.
PubMed 33347848Zheng YA, Lee YC, Huang JY, Hsieh HY, Chen YS, Chiang XH, Han PH, Lin MW, Hsu HH, Hung YP, Chen JS. Enhancing three-dimensional anatomical understanding in complex thoracic surgery: a comparative study of OpVerse and Synapse 3D. Eur J Cardiothorac Surg. 2025 Mar 28;67(4):ezaf069. doi: 10.1093/ejcts/ezaf069.
PubMed 40163682
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Extended Reality (XR)-Assisted PET/CT Fusion Navigation in Supraclavicular-to-Cervical Lymph Node Dissection for Lung Cancer
- ClinicalTrials.gov ID
- NCT07593872
- Acronym / sponsor ID
- XR-NeckLND / 202602094DINA
- Keywords
- Extended Reality, Augmented Reality, Surgical Navigation, PET/CT Fusion, Image-Guided Surgery, Digital Twin, Lymph Node Dissection, Mixed Reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XR-Assisted Surgical Planning | Experimental | Device: OpVerse XR Surgical Planning Platform with HoloLens HMD, Procedure: Cervical / Supraclavicular Lymph Node DissectionPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OpVerse XR Surgical Planning Platform with HoloLens HMDAn 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. | Device | XR-Assisted Surgical Planning |
| Cervical / Supraclavicular Lymph Node DissectionEn 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. | Procedure or surgery | XR-Assisted Surgical Planning |
Primary outcome
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.
6 secondary outcomes
Incidence of Procedure-Related Adverse Events
Time frame: 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)
PET Hotspot Clearance Rate
Time frame: At time of surgery
Target Registration Error (TRE)
Time frame: At time of surgery
Operative Time
Time frame: At time of surgery
Estimated Intraoperative Blood Loss
Time frame: At time of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Background: PubMed 21703862Ueda K, Tanaka T, Hayashi M, Tanaka N, Li TS, Hamano K. What proportion of lung cancers can be operated by segmentectomy? A computed-tomography-based simulation. Eur J Cardiothorac Surg. 2012 Feb;41(2):341-5. doi: 10.1016/j.ejcts.2011.05.034. Epub 2011 Dec 12.
- Background: PubMed 24442678Jensen K, Ringsted C, Hansen HJ, Petersen RH, Konge L. Simulation-based training for thoracoscopic lobectomy: a randomized controlled trial: virtual-reality versus black-box simulation. Surg Endosc. 2014 Jun;28(6):1821-9. doi: 10.1007/s00464-013-3392-7. Epub 2014 Jan 18.
- Background: PubMed 17223351Hu Y, Malthaner RA. The feasibility of three-dimensional displays of the thorax for preoperative planning in the surgical treatment of lung cancer. Eur J Cardiothorac Surg. 2007 Mar;31(3):506-11. doi: 10.1016/j.ejcts.2006.11.054. Epub 2007 Jan 16.
- Background: PubMed 36084694Bakhuis W, Sadeghi AH, Moes I, Maat APWM, Siregar S, Bogers AJJC, Mahtab EAF. Essential Surgical Plan Modifications After Virtual Reality Planning in 50 Consecutive Segmentectomies. Ann Thorac Surg. 2023 May;115(5):1247-1255. doi: 10.1016/j.athoracsur.2022.08.037. Epub 2022 Sep 6.
- Background: PubMed 30248803Sato M, Kobayashi M, Kojima F, Tanaka F, Yanagiya M, Kosaka S, Fukai R, Nakajima J. Effect of virtual-assisted lung mapping in acquisition of surgical margins in sublobar lung resection. J Thorac Cardiovasc Surg. 2018 Oct;156(4):1691-1701.e5. doi: 10.1016/j.jtcvs.2018.05.122. Epub 2018 Jul 20.
- Background: PubMed 33347848Sadeghi AH, Mathari SE, Abjigitova D, Maat APWM, Taverne YJHJ, Bogers AJJC, Mahtab EAF. Current and Future Applications of Virtual, Augmented, and Mixed Reality in Cardiothoracic Surgery. Ann Thorac Surg. 2022 Feb;113(2):681-691. doi: 10.1016/j.athoracsur.2020.11.030. Epub 2020 Dec 19.
- Background: PubMed 40163682Zheng YA, Lee YC, Huang JY, Hsieh HY, Chen YS, Chiang XH, Han PH, Lin MW, Hsu HH, Hung YP, Chen JS. Enhancing three-dimensional anatomical understanding in complex thoracic surgery: a comparative study of OpVerse and Synapse 3D. Eur J Cardiothorac Surg. 2025 Mar 28;67(4):ezaf069. doi: 10.1093/ejcts/ezaf069.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jin-Shing Chen principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing OpVerse XR Surgical Planning Platform with HoloLens HMD and Cervical / Supraclavicular Lymph Node Dissection in people with Non-Small Cell Lung Cancer and Lymph Node Metastasis, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chih-Hsiang Chang (+886-2-2312-3456 ext. 53384, changch1986@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Completion of XR-Assisted Preoperative Surgical Planning Workflow (time frame: Intraoperatively, prior to skin incision (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07593872, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.