Application of Extended Reality (XR)-Assisted CT-Guided Localization of Pulmonary Nodules in Thoracoscopic Sublobar Resection.

NCT06976684 | Not Yet Recruiting

• 1 other identifier: 202502149RINB
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Reality (XR)-Assisted CT-Guided Localization

Conditions

Lung Cancers; Metaverse; Virtual Surgical Simulation; Extended Reality (XR)

Keywords

Metaverse; virtual surgical simulation; Extended Reality (XR); Pulmonary Nodules; Digital Twin

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediatedly after Extended Reality (XR)-Assisted CT-Guided Localization

Secondary Outcomes (1)

• Assessment of perioperative outcomes

  The study assessment time frame from XR-assisted CT-guided localization to discharge is approximately 3 to 7 days.

Study Arms (1)

Extended Reality (XR)-Assisted CT-Guided Localization

EXPERIMENTAL

Procedure: Extended Reality (XR)-Assisted CT-Guided Localization

Interventions

Extended Reality (XR)-Assisted CT-Guided Localization PROCEDURE

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.

Extended Reality (XR)-Assisted CT-Guided Localization

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Lung Neoplasms; Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Xu-Heng Chiang

CONTACT

88672655136; lycansblueray@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 16, 2025
• Study Start: May 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share