Performance Study for InferRead CT Pneumonia.AI
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 423
- 主要终点
- Primary Endpoint
研究概览
简要总结
A retrospective, blineded, multicenter study of the InferRead CT Pneumonia.AI to evaluate the performance in identifying non-contrast chest CT scans containing pneumonia findings.
详细描述
This is a retrospective, blinded, multicenter study for the InferRead CT Pneumonia.AI. The primary endpoint will evaluate the software's performance in identifying non-contrast chest CT scans containing pneumonia. It will evaluate InferRead CT Pneumonia.AI in terms of sensitivity and specificity with respect to a ground truth, as established by trained thoracic radiologists, in the detection of penumonia. In addition, the study will compare time to notification for the InferRead CT Pneumonia.AI software with respect to the time to notification for the standard of care as established from available radiological reports.
- To evaluate the performance of InferRead CT Pneumonia.AI.
- To evaluate the effect of different factors such as CT manufacturer, CT scanning protocols and patient characteristics on the performance of InferRead CT Pneumonia.AI
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-contrast chest CT DICOM scans
- •Contains both lung lobes
- •Slice thickness is less than 3 mm.
排除标准
- •Incomplete scan or corrupted scan
- •Irregular scanning, increased intrapulmonary density due to insufficient inspiration, and respiratory artifacts affecting the physician's judgment.
- •Altered or absent lung morphology in the postoperative patient.
结局指标
主要结局
Primary Endpoint
时间窗: 1/1/2022 - 2/28/2022
1. The Sensitivity (SE) of InferRead CT Pneumonia.AI is higher than 0.80. H0: YSE ≤ 0.80 HA: YSE \> 0.80 2. The Specificity (SP) of InferRead CT Pneumonia.AI is higher than 0.80. H0: YSP ≤ 0.80 HA: YSP \> 0.80
次要结局
- Secondary Endpoint(1/1/2022 - 2/28/2022)