Clinical Validation Study on the Imaging Efficacy of Mobile 4D CBCT Technology for Peripheral Pulmonary Lesions

NCT ID: NCT07149597

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-06-30

Brief Summary

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The purpose of this study is to evaluate the clinical value of mobile 4D CBCT technology in the diagnosis and treatment of peripheral pulmonary lesions and to validate its intraoperative dynamic three-dimensional CT imaging capability.

Detailed Description

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This is a single-arm, single-center, prospective study in which approximately 50 patients with peripheral pulmonary lesions will undergo mobile cone-beam computed tomography (CBCT) scanning. In the field of respiratory intervention, mobile CBCT enables real-time intraoperative three-dimensional CT imaging of lesions, providing a more intuitive visualization of the positional relationship between biopsy tools and the target area, offering significant value in bronchoscopic examinations. In this study, CBCT images will be acquired from participants and reconstructed into three-dimensional models. Subsequent analysis will be conducted to evaluate the performance of mobile 4D CBCT three-dimensional reconstruction technology.

Conditions

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Peripheral Pulmonary Lesions (PPLs)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Mobile CBCT Group

This study aims to explore the clinical value of mobile 4D CBCT technology in the diagnosis and treatment of peripheral pulmonary lesions, and to validate its intraoperative three-dimensional CT imaging capability. Preoperative fluoroscopic localization will be performed, followed by two rounds of three-dimensional scanning using a mobile C-arm system to acquire volumetric CT images of the patients. The obtained images will be exported and processed postoperatively, and analyzed from both quantitative and qualitative perspectives.

Mobile CBCT Three-Dimensional Scanning

Intervention Type RADIATION

Mobile CBCT Three-Dimensional Scanning

Interventions

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Mobile CBCT Three-Dimensional Scanning

Mobile CBCT Three-Dimensional Scanning

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

1. Age \>18 years old.
2. Patients whose chest CT scans indicate the presence of peripheral pulmonary lesions and require further diagnosis via transbronchial lung biopsy (TBLB).
3. Lesion size: 8 mm \< longest diameter of lesion ≤ 50 mm.
4. Understands the study and has provided signed informed consent.

Exclusion Criteria

1. Contraindications to bronchoscopy are present.
2. Severe cardiopulmonary dysfunction or other conditions that may increase surgical risk.
3. The investigator considers that the patient has other conditions which make them unsuitable for participation in this study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Chest Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jiayuan Sun

Director, Department of Respiratory Endoscopy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiayuan Sun

Role: STUDY_DIRECTOR

Shanghai Chest Hospital

Locations

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Shanghai Chest Hospital

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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Jiayuan Sun

Role: CONTACT

+1511 +86-021-22200000

Facility Contacts

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Jiayuan Sun

Role: primary

+1511 +86-021-22200000

Other Identifiers

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IS25179

Identifier Type: -

Identifier Source: org_study_id

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