An interventional study of Extended Reality (XR)-Assisted CT-Guided Localization in Lung Cancers, Metaverse and Virtual Surgical Simulation, sponsored by National Taiwan University Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
Reality (XR)-Assisted CT-Guided Localization
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.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 3,656 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Extended Reality (XR)-Assisted CT-Guided Localization
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.
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.
Time frame: Immediatedly after Extended Reality (XR)-Assisted CT-Guided Localization
Assessment of perioperative outcomes
Perioperative outcomes, including but not limited to intraoperative blood loss, localization time, and operative time, will be measured.
Time frame: The study assessment time frame from XR-assisted CT-guided localization to discharge is approximately 3 to 7 days.
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for May 2025; primary completion for Dec 2025, 7 months later.
Of 864 non-industry interventional studies with no phase under Lung Neoplasms, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 68. This study's planned 7 months is below that.
Counting every sponsor, half of 915 studies reached it within 34 months; a quarter within 15 and three quarters within 67.
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This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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