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NCT Number: NCT07149597

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Chest Hospital

Shanghai, China

Location contact

Jiayuan Sun

CONTACT

[email protected]

+1511 +86-021-22200000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobile CBCT Three-Dimensional Scanning

Radiation

Mobile CBCT Three-Dimensional Scanning

Primary outcomes

  1. RMSE(Root Mean Squared Error)

    Time frame: 1 year

    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.

  2. SSIM (Structural Similarity )

    Time frame: 1 year

    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.

Secondary outcomes

  1. Image Quality

    Time frame: 1 year

    Three 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.

  2. Slice Continuity

    Time frame: 1 year

    Three 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiayuan Sun

CONTACT

[email protected]

+1511 +86-021-22200000

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 2, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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