Clinical trial NCT06976684: Application of Extended Reality (XR)-Assisted CT-Guided Localization of Pulmonary Nodules in Thoracoscopic Sublobar Resection.
Official title: Application of Extended Reality (XR)-Assisted CT-Guided Localization of Pulmonary Nodules in Thoracoscopic Sublobar Resection.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Cancers
Metaverse
Virtual Surgical Simulation
Extended Reality (XR)
Keywords: Metaverse
virtual surgical simulation
Extended Reality (XR)
Pulmonary Nodules
Digital Twin
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients younger than 18 or older than 80 years.
* Patients requiring lobectomy.
* Patients who have not provided written informed consent.
* Vulnerable populations.

Primary outcomes:
measure: The Accuracy of Extended Reality (XR)-Assisted CT-Guided Localization
timeFrame: Immediatedly after Extended Reality (XR)-Assisted CT-Guided Localization
Secondary outcomes:
measure: Assessment of perioperative outcomes
timeFrame: The study assessment time frame from XR-assisted CT-guided localization to discharge is approximately 3 to 7 days.
Other outcomes:
Locations:
Study officials:
References: