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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Chest Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Patients who underwent mobile CBCT scanning.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Mobile CBCT Three-Dimensional Scanning

    Radiation

    Mobile CBCT Three-Dimensional Scanning

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Mobile CBCT Group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year
2

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.

Time frame
1 year

Secondary outcomes

1

Image Quality

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.

Time frame
1 year
2

Slice Continuity

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.

Time frame
1 year

Other outcomes

Sponsors and contacts

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