Clinical Validation Study on the Imaging Efficacy of Mobile 4D CBCT Technology for Peripheral Pulmonary Lesions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mobile CBCT Three-Dimensional Scanning.
- Who it may be relevant to
- Registry conditions: Peripheral Pulmonary Lesions (PPLs). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Interventions
- Radiation Mobile CBCT Three-Dimensional Scanning
Mobile CBCT Three-Dimensional Scanning
Primary outcome measures
- RMSE（Root Mean Squared Error） [Time frame: 1 year]
- SSIM (Structural Similarity ) [Time frame: 1 year]
Secondary outcome measures (2)
- Image Quality [Time frame: 1 year]
- Slice Continuity [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Age >18 years old.
- Patients whose chest CT scans indicate the presence of peripheral pulmonary lesions and require further diagnosis via transbronchial lung biopsy (TBLB).
- Lesion size: 8 mm < longest diameter of lesion ≤ 50 mm.
- Understands the study and has provided signed informed consent.
Exclusion criteria
- Contraindications to bronchoscopy are present.
- Severe cardiopulmonary dysfunction or other conditions that may increase surgical risk.
- The investigator considers that the patient has other conditions which make them unsuitable for participation in this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 1 center
- Shanghai Chest Hospital — Shanghai
Identifiers
NCT: NCT07149597 · IS25179