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

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Peripheral Pulmonary Lesions (PPLs)

Treatments: Radiation: Mobile CBCT Three-Dimensional Scanning

Study type: Observational

Funder types: Other

Identifiers

NCT07149597

IS25179

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Mobile CBCT Group

Description:

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.

Treatment:

Radiation: Mobile CBCT Three-Dimensional Scanning