Skip to content

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07149597
Enrollment
50
Registered
2025-09-02
Start date
2025-09-01
Completion date
2026-06-30
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Pulmonary Lesions (PPLs)

Keywords

Mobile Cone-Beam Computed Tomography, Artificial Intelligence, Peripheral Pulmonary Lesions

Brief summary

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

RADIATIONMobile CBCT Three-Dimensional Scanning

Mobile CBCT Three-Dimensional Scanning

Sponsors

Shanghai Chest Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
RMSE(Root Mean Squared Error)1 yearRMSE (Root Mean Square Error): A commonly used metric for measuring the difference between predicted values and actual values. It is applicable in regression problems and image quality assessment. A smaller RMSE value indicates more accurate predictions, with 0 representing perfect accuracy, while a larger value indicates greater error.
SSIM (Structural Similarity )1 yearSSIM (Structural Similarity ): A metric used to measure the similarity between two images, comparing them across three dimensions: luminance, contrast, and structure. The SSIM value ranges from \[-1, 1\], where 1 indicates that the two images are identical, and 0 or negative values indicate complete dissimilarity.

Secondary

MeasureTime frameDescription
Image Quality1 yearThree experienced experts scored the three-dimensional CT reconstruction images based on image quality using the following criteria:4 points: Exceptionally clear images;3 points: Generally clear images with a few blurred slices;2 points: Basically clear images but with several blurred slices;1 point: Unclear images.
Slice Continuity1 yearThree experienced experts scored the three-dimensional CT reconstruction images based on slice continuity using the following criteria:4 points: All slices exhibit continuous anatomical structures;3 points: Overall continuous with minor discontinuities in a few slices;2 points: Generally continuous but with noticeable discontinuities in multiple slices;1 point: Predominantly discontinuous across most slices.

Countries

China

Contacts

Primary ContactJiayuan Sun
jysun1976@163.com+1511 +86-021-22200000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026