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

NCT07149597 | Not Yet Recruiting

• 1 other identifier: IS25179
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Pulmonary Lesions (PPLs)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• RMSE（Root Mean Squared Error）

  RMSE (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.

  1 year

• SSIM (Structural Similarity )

  SSIM (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.

  1 year

Secondary Outcomes (2)

• Image Quality

  1 year

• Slice Continuity

  1 year

Study Arms (1)

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.

Radiation: Mobile CBCT Three-Dimensional Scanning

Interventions

Mobile CBCT Three-Dimensional Scanning RADIATION

Mobile CBCT Three-Dimensional Scanning

Mobile CBCT Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent mobile CBCT scanning.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

Location

Study Officials

• Jiayuan Sun

  Shanghai Chest Hospital

  STUDY DIRECTOR

Central Study Contacts

Jiayuan Sun

CONTACT

+1511 +86-021-22200000; jysun1976@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Respiratory Endoscopy

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: September 2, 2025
• Study Start: September 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)