Clinical Validation Study on the Imaging Efficacy of Mobile 4D CBCT Technology for Peripheral Pulmonary Lesions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- RMSE（Root Mean Squared Error）
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
RMSE（Root Mean Squared Error）
时间窗: 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.
SSIM (Structural Similarity )
时间窗: 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.
次要结局
- Image Quality(1 year)
- Slice Continuity(1 year)
研究者
Jiayuan Sun
Director, Department of Respiratory Endoscopy
Shanghai Chest Hospital