Performance Estimation of Triaging Artificial Intelligence Based Computer-Aided Detection Algorithm in Routine Chest Radiography
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 44,900
- 试验地点
- 1
- 主要终点
- number of patients with actionable lung nodule as measured by CT scan
研究概览
简要总结
chest x-rays will be analyzed by AI software for a secondary read of lung nodules. Chest x-rays will either be sent to the AI tool to be read or to radiologists to read. If the image is sent to the AI tool, the AI software will generate a report on if it detects a lung nodule or not. The image will then be sent to a radiologist to determine if there is agreement or disagreement with the AI tool.
详细描述
The study is a prospective study for measuring the performance of an AI software in detecting lung nodules from chest X-rays. Data collected during the study will be analyzed for study purposes after end date of data collection.
There will be two study arms: the control arm and the interventional arm.
Control Arm:
There will be no interruption to the existing standard of care pathway.
Interventional Arm:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chest X-ray images of patients aged 18 - 89 years.
- •Modality: CR/DR/DX.
- •Lung nodules measuring 6 mm -30 mm (for chest X-ray images where presence of nodules is required).
排除标准
- •Incomplete view of the chest.
- •Lateral view
- •Known lung cancer at the time of Chest x-ray images.
研究组 & 干预措施
Image going through AI tool
these are the images going through the AI tool
干预措施: AI Based CAD Software (qXR-Ln) (Device)
image not going through AI tool
these are the images not going through the AI tool
结局指标
主要结局
number of patients with actionable lung nodule as measured by CT scan
时间窗: up to one year
total number of patients having chest x-ray
时间窗: up to one year
number of patients with high risk lung nodule as measured by CT scan
时间窗: up to one year
total number of patients referred for a CT scan
时间窗: up to one year
number of lung nodule positive images
时间窗: up to one year
number of lung nodule negative images
时间窗: up to one year
次要结局
未报告次要终点
研究者
Amit Gupta, MD
Associate Professor, Department of Radiology, School of Medicine Member, Cancer Imaging Program, Case Comprehensive Cancer Center, Cardiothoracic Division Chief department of Radiology
University Hospitals Cleveland Medical Center