GE Healthcare VolumeRAD Lung Nodule Detection Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 187
- 试验地点
- 4
- 主要终点
- Multi-reader, multi-case Receiver Operating Characteristics (ROC) methodology.
研究概览
简要总结
To perform a multiple reader, multiple case (MRMC) observer study assessing the detection performance of VolumeRAD tomosynthesis of the chest in detecting lung nodules.
详细描述
Digital tomosynthesis is a form of limited angle tomography that creates a series of section images using a conventional x-ray tube and generator, a digital detector, and appropriate reconstruction software. It creates section images from a series of projection images acquired as the x-ray tube moves along a prescribed path. Because tomosynthesis can minimize the visual presence of overlying anatomy - the ribs, for example - it has the potential to improve the detection of lesions such as pulmonary nodules when compared with conventional chest radiography.
The primary aim of this study is to determine whether the use of VolumeRAD tomosynthesis, in addition to CxR, increases physician accuracy in the detection of lung nodules between 3mm and 20mm in diameter when compared to conventional posterior-anterior (PA) and lateral (LAT) chest radiography (CxR). This aim will be addressed by measuring free-response performance of experienced (with VolumeRAD), blinded expert readers' detection performance. Specifically, we will compare detection performance, as measured by the area under the alternative free response receiver operating characteristic (AFROC) curve, among readers viewing PA and LAT chest X-rays versus VolumeRAD tomosynthesis. The nodule will be the unit of analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Scheduled for chest CT as part of their needed medical care;
- •If available, individuals who have had previous imaging to suggest they fulfill the needs of the study;
- •18 years of age, or older;
- •In good enough physical condition to stand motionless and hold their breath during the image acquisition procedures.
排除标准
- •Children under 18 years of age;
- •Women who are pregnant or who suspect they may be pregnant;
- •Individuals who on previous imaging are shown to have objects in or around the lungs that might produce substantial artifacts that would obscure pulmonary nodules;
- •Individuals who on recent imaging had active lung or pleural disease that would obscure pulmonary nodules;
- •Individuals with more than 5 pulmonary nodules between 5mm and 20mm in diameter in either right or left lung.
- •Individuals suspected to have more than 15 total nodules between 3mm and 20mm. NOTE that up to 20 nodules between 3mm and 20mm will be allowed in the final study sample.
结局指标
主要结局
Multi-reader, multi-case Receiver Operating Characteristics (ROC) methodology.
时间窗: Post accrual of 210 participants
The primary objective of this study is to determine if the use of VolumeRAD tomosynthesis increases the accuracy of the detection of lung nodules between 3mm and 20mm in diameter when compared to conventional PA and lateral chest radiography alone.
次要结局
- Actionability classification accuracy of all modalities(Multipe reader, multiple case reader study)