Clinical Study for Spectral Precise Image (SPI) Algorithm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 3
- 主要终点
- Image Quality (IQ) of Spectral Precise Image reconstructions non-inferior to iDose4 for spectral images of MonoE (MonoE 70Kev for Cardiac and for Body/ MonoE 66KeV for Head).
研究概览
简要总结
The goal of the study is to evaluate the Image Quality (IQ), and diagnostic confidence of Spectral Precise Image for CT 7700 Scanner as compared with iDose4 as a standard-of-care reference.
详细描述
Spectral Precise Image is a reconstruction technique where the system uses a trained deep learning neural network to produce an image that reduces noise while improving low contrast detectability and maintaining the appearance of traditional filtered back projection (FBP) images.
Spectral Precise Image in Spectral CT 7700 system supports both conventional and spectral reconstructions.
The study will use raw data of subjects that are over the age of 22 years and scanned by Philips Spectral CT.
Study raw data, following anonymization, will be transferred to Philips for reconstructions, both conventional and spectral images will be reconstructed with iDose4 and with Spectral Precise Image at 100% dose.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Subjects scanned by Spectral CT (K203020) according to the department standard of care clinical protocols.
- •Subjects age > twenty-two (22) years
排除标准
- •• Scans that the site radiologists have deemed as non-diagnostic image quality in the standard practice (e.g. patient movement)
- •Scans that are not completed due to technical difficulties
结局指标
主要结局
Image Quality (IQ) of Spectral Precise Image reconstructions non-inferior to iDose4 for spectral images of MonoE (MonoE 70Kev for Cardiac and for Body/ MonoE 66KeV for Head).
时间窗: 1 day
Primary Endpoint (Co-Primary endpoints): 2. The Image Quality (IQ) and diagnostic confidence of Spectral Precise Image reconstructions is at least as good as (non-inferior to)-iDose4 for spectral images of MonoE (MonoE 70Kev for Cardiac and for Body/ MonoE 66KeV for Head).
Image Quality (IQ) of Spectral Precise Image reconstructions non inferior to iDose conventional images
时间窗: 1 day
Primary Endpoint (Co-Primary endpoints): 1\. The Image Quality (IQ) and diagnostic confidence of Spectral Precise Image reconstructions is at least as good as (non-inferior to) iDose4 for conventional images.
次要结局
- Evaluation of the differences in Image Quality (IQ) of Spectral Precise Image reconstructions versus iDose conventional images(1 day)
- Evaluation of the success rate for Spectral Precise Image reconstruction(1 day)
- Evaluation of the interobserver agreement level for the Co-Primary endpoints(1 day)
- Evaluation of images artifacts visualization and preservation of important features(1 day)