Lung CancersNCT06976684
Application of Extended Reality (XR)-Assisted CT-Guided Localization of Pulmonary Nodules in Thoracoscopic Sublobar Resection.
A study testing Extended Reality (XR)-Assisted CT-Guided Localization in people with Lung Cancers and Metaverse, run by National Taiwan University Hospital.
Trial summary
Reality (XR)-Assisted CT-Guided Localization Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancers, Metaverse, Virtual Surgical Simulation
- What is being tested?
- Extended Reality (XR)-Assisted CT-Guided Localization
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Dec 2025
- 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
- Patients aged between 18 and 80 who are scheduled to undergo lung nodule resection surgery.
- Patients with lung nodules smaller than 2 cm that require preoperative localization.
- Patients with lung nodules located in the outer one-third of the lung.
Who cannot join
- Patients younger than 18 or older than 80 years.
- Patients requiring lobectomy.
- Patients who have not provided written informed consent.
- Vulnerable populations.
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
Reality (XR)-Assisted CT-Guided Localization
Read the detailed description
With the widespread use of computed tomography (CT), lung nodules detected through screening have become increasingly smaller. These small nodules are often hidden within the lung parenchyma, making them difficult to visualize or palpate during surgery. As a result, nodule localization techniques have become critically important and are heavily relied upon by thoracic surgeons. Currently, CT-guided localization is the standard approach; however, this requires patients to move between the CT suite, the ward, and the operating room, which is highly inconvenient.
An alternative is the use of a one-stop hybrid operating room, which integrates imaging and surgery in a single space, but this solution is costly. This study aims to enroll 20 patients in a pilot investigation of using extended reality (XR)-guided localization in video-assisted thoracoscopic surgery (VATS) for lung nodule resection. By leveraging current XR technologies, a digital twin model will be superimposed onto the patient's body. Our team-developed virtual localization technique will then be used to mark the tumor site with dye, enabling surgeons to precisely excise the tumor with minimal tissue removal.
If successful, this technology has the potential to replace traditional CT-guided or hybrid operating room localization, thereby reducing patient inconvenience and financial burden, and ultimately achieving a streamlined and cost-effective surgical workflow.
- Being tested
- Extended Reality (XR)-Assisted CT-Guided Localization
- Keywords
- Metaverse, virtual surgical simulation, Extended Reality (XR), Pulmonary Nodules, Digital Twin
- Medical subject headings
- Lung Neoplasms, Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended Reality (XR)-Assisted CT-Guided LocalizationProcedure or surgery
This study plans to collect approximately 20 localization cases from multiple centers within our hospital. Initially, two sets of preoperative simulated CT scans (at end-inhalation and end-exhalation) will be performed in the CT suite to construct a usable model of the surgical posture and the lesion. Subsequently, in the hybrid operating room, a digital twin model will be applied to the patient using a metaverse platform. Guided by virtual localization lines, percutaneous injection of Patent Blue dye will be carried out at end-exhalation for accurate marking of the lesion. Immediately after the injection, intraoperative CT within the hybrid operating room will be used to verify the localization. If the accuracy is suboptimal (with a deviation greater than 2 cm), standard CT-guided Patent Blue dye localization will be performed as a supplementary measure to complete the localization and proceed with surgery.
| Study group | Role | What they receive |
|---|---|---|
| Extended Reality (XR)-Assisted CT-Guided Localization | Experimental | Not described Receives: Procedure: Extended Reality (XR)-Assisted CT-Guided Localization |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Accuracy of Extended Reality (XR)-Assisted CT-Guided Localization
Procedures in this study will be conducted in a hybrid operating room featuring cone-beam CT. The accuracy of XR-assisted CT-guided localization will be assessed immediately post-localization by employing cone-beam CT to ascertain the needle tip position and measure the distance to the target tumor.
Measured: Immediatedly after Extended Reality (XR)-Assisted CT-Guided Localization
Secondary outcomes (1)
Assessment of perioperative outcomes
Perioperative outcomes, including but not limited to intraoperative blood loss, localization time, and operative time, will be measured.
Measured: The study assessment time frame from XR-assisted CT-guided localization to discharge is approximately 3 to 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study startMay 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancersStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976684
- Sponsor's protocol ID
- 202502149RINB
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data (IPD) collected during this study will generally not be shared with other researchers, primarily due to patient privacy considerations. However, limited access to de-identified IPD may be considered in exceptional cases upon a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Extended Reality (XR)-Assisted CT-Guided Localization of Pulmonary Nodules in Thoracoscopic Sublobar Resection.
- ClinicalTrials.gov ID
- NCT06976684
- Acronym / sponsor ID
- 202502149RINB
- Keywords
- Metaverse, virtual surgical simulation, Extended Reality (XR), Pulmonary Nodules, Digital Twin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 May 2025 (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.
Reality (XR)-Assisted CT-Guided Localization
Detailed description
With the widespread use of computed tomography (CT), lung nodules detected through screening have become increasingly smaller. These small nodules are often hidden within the lung parenchyma, making them difficult to visualize or palpate during surgery. As a result, nodule localization techniques have become critically important and are heavily relied upon by thoracic surgeons. Currently, CT-guided localization is the standard approach; however, this requires patients to move between the CT suite, the ward, and the operating room, which is highly inconvenient.
An alternative is the use of a one-stop hybrid operating room, which integrates imaging and surgery in a single space, but this solution is costly. This study aims to enroll 20 patients in a pilot investigation of using extended reality (XR)-guided localization in video-assisted thoracoscopic surgery (VATS) for lung nodule resection. By leveraging current XR technologies, a digital twin model will be superimposed onto the patient's body. Our team-developed virtual localization technique will then be used to mark the tumor site with dye, enabling surgeons to precisely excise the tumor with minimal tissue removal.
If successful, this technology has the potential to replace traditional CT-guided or hybrid operating room localization, thereby reducing patient inconvenience and financial burden, and ultimately achieving a streamlined and cost-effective surgical workflow.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extended Reality (XR)-Assisted CT-Guided Localization | Experimental | Procedure: Extended Reality (XR)-Assisted CT-Guided Localization |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 18 and 80 who are scheduled to undergo lung nodule resection surgery.
- Patients with lung nodules smaller than 2 cm that require preoperative localization.
- Patients with lung nodules located in the outer one-third of the lung.
Key exclusion criteria (4 listed)
- Patients younger than 18 or older than 80 years.
- Patients requiring lobectomy.
- Patients who have not provided written informed consent.
- Vulnerable populations.
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 |
|---|---|---|
| Extended Reality (XR)-Assisted CT-Guided LocalizationThis study plans to collect approximately 20 localization cases from multiple centers within our hospital. Initially, two sets of preoperative simulated CT scans (at end-inhalation and end-exhalation) will be performed in the CT suite to construct a usable model of the surgical posture and the lesion. Subsequently, in the hybrid operating room, a digital twin model will be applied to the patient using a metaverse platform. Guided by virtual localization lines, percutaneous injection of Patent Blue dye will be carried out at end-exhalation for accurate marking of the lesion. Immediately after the injection, intraoperative CT within the hybrid operating room will be used to verify the localization. If the accuracy is suboptimal (with a deviation greater than 2 cm), standard CT-guided Patent Blue dye localization will be performed as a supplementary measure to complete the localization and proceed with surgery. | Procedure or surgery | Extended Reality (XR)-Assisted CT-Guided Localization |
Primary outcome
The Accuracy of Extended Reality (XR)-Assisted CT-Guided Localization
Time frame: Immediatedly after Extended Reality (XR)-Assisted CT-Guided Localization
Procedures in this study will be conducted in a hybrid operating room featuring cone-beam CT. The accuracy of XR-assisted CT-guided localization will be assessed immediately post-localization by employing cone-beam CT to ascertain the needle tip position and measure the distance to the target tumor.
1 secondary outcome
Assessment of perioperative outcomes
Time frame: The study assessment time frame from XR-assisted CT-guided localization to discharge is approximately 3 to 7 days.
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 16 May 2025.
- Individual participant dataSharing planned: No. De-identified individual participant data (IPD) collected during this study will generally not be shared with other researchers, primarily due to patient privacy considerations. However, limited access to de-identified IPD may be considered in exceptional cases upon a reasonable request.
Related trials for Lung Cancers
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Questions about this trial
What is this clinical trial studying?
A study testing Extended Reality (XR)-Assisted CT-Guided Localization in people with Lung Cancers and Metaverse, 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 3 inclusion and 4 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 16 May 2025. 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 Xu-Heng Chiang (88672655136, lycansblueray@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Accuracy of Extended Reality (XR)-Assisted CT-Guided Localization (time frame: Immediatedly after Extended Reality (XR)-Assisted CT-Guided Localization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2025.