A Clinical Study of LUNG-CT CAD Decision Support
试验速览
- 阶段
- 不适用
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Area under the ROC Curve(AUC)
研究概览
简要总结
This product is a computer-aided detection software designed to assist clinicians in detecting lung nodules in chest computer tomography. This product receives from PACS, radiology information system or directly from computer tomography scanner. After receiving the image, the product performs image analysis and provides a mark of suspected lung nodules. Users can use existing medical image capture and transmission systems or reading software to view these annotations on the workstation.
The main purpose of this trial is to verify that when clinicians perform chest CT pulmonary nodule detection, compared to only diagnosis based on chest CT images, whether the "Taihao" lung CT decision support system helps to improve the diagnostic efficiency of clinicians.
The secondary purpose is to evaluate that when clinicians perform chest CT pulmonary nodule detection, compared to only diagnosis based on chest CT images, whether the "Taihao" lung CT decision support system helps to improve the sensitivity, specificity, and image interpretation time (Reading Time) of clinicians.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cases of men or women aged between 20 and
- •At Changhua Christian Hospital or Yuanlin Christian Hospital, expert (qualified for interpretation of chest computed tomography lung nodules) confirms that the original low-dose computed tomography image had pulmonary nodules (part solid nodule, solid nodule, and pulmonary nodules greater than or equal to 3 mm), and verified that it is as a true nodule through follow-up clinical imaging examination or clinical determination, or
- •At Changhua Christian Hospital or Yuanlin Christian Hospital, the subject has undergone a low-dose lung computed tomography and a physician (qualified for interpretation of chest computed tomography lung nodules) confirmed that there are no lung nodules on the computed tomography scan.
排除标准
- •The computerized tomography of the lungs and obvious administrative or technical errors.
- •A physician (qualified for interpretation of chest CT pulmonary nodules) confirms cases with severe infections such as tuberculosis and pneumonia from source report or other medical records.
- •A physician (qualified for interpretation of chest CT pulmonary nodules) confirms cases with lung fibrosis such as pneumoconiosis from source report or other medical records.
- •Test cases used when training physicians to use the lung computer tomography decision support system.
研究组 & 干预措施
Control Group
Participating clinicians will perform lung nodule detection on 200 cases of lung low-dose computed tomography images
Experimental Group - with the aid of "Taihao" lung CT decision support system
Participating clinicians will perform lung nodule detection on 200 cases of lung low-dose computed tomography images with the aid of "Taihao" lung CT decision support system
干预措施: Ti-LUNG (Device)
结局指标
主要结局
Area under the ROC Curve(AUC)
时间窗: 4 months
The primary outcome measure is the area under the receiver operating characteristic (ROC) curve of the radiologists, also known as c statistic.
次要结局
- Sensitivity(4 months)
- Specificity(4 months)
- Interpretation time(4 months)