- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07434167
Extended Reality (XR)-Assisted CT Localization of Pulmonary Nodules
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The objective of this study is to investigate the safety and feasibility of extended reality (XR)-assisted computed tomography (CT)-guided localization of pulmonary nodules for preoperative tumor localization. The study aims to utilize a fully developed XR system to assist physicians in performing preoperative localization of pulmonary tumors, while also optimizing the workflow and efficiency of pulmonary nodule localization in a conventional CT suite.
This study plans to enroll 30 patients at our institution who are scheduled to undergo thoracoscopic sublobar resection. The safety and feasibility of using an XR-assisted digital twin model for pulmonary nodule localization in a standard CT suite will be evaluated.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xu-Heng Chiang
- Phone Number: 88672655136
- Email: lycansblueray@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 requiring lobectomy.
- Patients who have not provided written informed consent.
- Vulnerable populations.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Extended Reality (XR)-Assisted CT Localization of Pulmonary Nodules
|
This study plans to collect approximately 30 localization cases from multiple centers within our institution. First, after patient positioning and immobilization in the computed tomography (CT) suite, a chest CT scan is performed. Imaging data are processed using semi-automatic segmentation and rapid reconstruction techniques to generate, in real time, a three-dimensional model that corresponds to the patient's current localization position. During the construction of the three-dimensional model, patients remain in a fixed position. To reduce anxiety and discomfort associated with waiting, patient education related to pulmonary nodule localization and thoracoscopic surgery is provided during this period. The educational content includes the purpose of the procedure, procedural steps, potential risks, and key points of postoperative care. Once model construction is completed, a metaverse-based XR platform is used in the same setting to overlay the digital twin model onto the patient's |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Localization accuracy
Time Frame: Immediatedly after Extended Reality (XR)-Assisted CT-Guided Localization
|
Procedures in this study will be conducted in a CT room.
The accuracy of XR-assisted CT-guided localization will be assessed immediately after localization by employing in-room CT to determine the needle tip position and measure the distance to the target tumor.
|
Immediatedly after Extended Reality (XR)-Assisted CT-Guided Localization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Perioperative outcomes, including intraoperative blood loss, localization time, operative time, and the rate of localization-related complications, will be measured.
We will assess whether the incorporation of the localization system leads to reductions in these parameters.
|
The study assessment time frame from XR-assisted CT-guided localization to discharge is approximately 3 to 7 days.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202601025RINB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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