Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:25 AM
Study NCT ID:
NCT07434167
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extended Reality (XR)-Assisted CT Localization of Pulmonary Nodules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-22', 'studyFirstSubmitDate': '2026-02-05', 'studyFirstSubmitQcDate': '2026-02-22', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Localization accuracy', 'timeFrame': 'Immediatedly after Extended Reality (XR)-Assisted CT-Guided Localization', 'description': '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.'}], 'secondaryOutcomes': [{'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.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metaverse', 'Extended Reality (XR)', 'Digital Twin', 'Localization of Pulmonary Nodules', 'uniportal VATS'], 'conditions': ['Lung Cancers', 'Metaverse', 'Extended Reality (XR)']}, 'descriptionModule': {'briefSummary': 'Extended Reality (XR)-Assisted CT Localization of Pulmonary Nodules', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 18 and 80 who are scheduled to undergo lung nodule resection surgery.\n* Patients with lung nodules smaller than 2 cm that require preoperative localization.\n* Patients with lung nodules located in the outer one-third of the lung.\n\nExclusion Criteria:\n\n* Patients requiring lobectomy.\n* Patients who have not provided written informed consent.\n* Vulnerable populations.'}, 'identificationModule': {'nctId': 'NCT07434167', 'briefTitle': 'Extended Reality (XR)-Assisted CT Localization of Pulmonary Nodules', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Extended Reality (XR)-Assisted CT Localization of Pulmonary Nodules', 'orgStudyIdInfo': {'id': '202601025RINB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extended Reality (XR)-Assisted CT Localization of Pulmonary Nodules', 'interventionNames': ['Procedure: Extended Reality (XR)-Assisted CT Localization of Pulmonary Nodules']}], 'interventions': [{'name': 'Extended Reality (XR)-Assisted CT Localization of Pulmonary Nodules', 'type': 'PROCEDURE', 'description': "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.\n\nDuring 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", 'armGroupLabels': ['Extended Reality (XR)-Assisted CT Localization of Pulmonary Nodules']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xu-Heng Chiang', 'role': 'CONTACT', 'email': 'lycansblueray@gmail.com', 'phone': '88672655136'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}