Clinical Investigation Plan for IQon Spectral CT at Utrecht Medical Center (UMC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 980
- 试验地点
- 2
- 主要终点
- Degree of improvement in specificity (measures the proportion of negatives that are correctly identified) of spectral coronary CTA for detection of coronary stenoses in need of treatment over conventional coronary CTA
研究概览
简要总结
The CT examination on IQon Spectral CT would be a standard of care CT performed as per the clinical indication. The conventional CT images generated by the scanner will be used for clinical purposes as routinely practiced. And therefore, the primary study aim is to assess the impact of IQon Spectral CT scanner and applications on the clinical workflow of the site as well as the diagnostic confidence levels of the physicians reading the CT cases.
In addition to the aim mentioned above, the investigators would like to develop recommendations for the clinical application of the spectral images in routine use. Such recommendations could include optimization of scanning protocols, optimization of reconstruction parameters; evaluate the utility of iodine maps and other supported materials.
详细描述
The study aim is to assess the added diagnostic value and impact on workflow of Philips IQon Spectral Computed Tomography.
The IQon Spectral CT generates two result types:
- Conventional CT images which are equivalent to images produced by the commercially available Brilliance iCT scanner
- Spectral CT images which are unique to this product.
The CT examination would be a standard of care CT performed as per the clinical indication.
In addition to the aim mentioned above, the investigators would like to develop recommendations for the clinical application of the spectral images in routine use. Such recommendations could include optimization of scanning parameters, optimization of reconstruction parameters to utilize the capabilities of the IQon system etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects clinically indicated to have a CT scan as part of their routine, standard medical care. Subjects must be capable of providing informed consent for the retrospective use and analysis of the IQon Spectral CT data for the research study.
排除标准
- •Subjects that are not clinically indicated to have a CT scan as part of their routine, standard medical care. Subjects that are not capable of providing informed consent for the retrospective use and analysis of the IQon Spectral CT data for the research study.
研究组 & 干预措施
Spectral CT image
Interventions: IQon Spectral CT
干预措施: IQon Spectral CT (Device)
结局指标
主要结局
Degree of improvement in specificity (measures the proportion of negatives that are correctly identified) of spectral coronary CTA for detection of coronary stenoses in need of treatment over conventional coronary CTA
时间窗: One Year
次要结局
- Change in specificity (measures the proportion of negatives that are correctly identified) of SDCT versus conventional CT scanning for characterizing pulmonary nodules.(One Year)
- Change in sensitivity (measures the proportion of positives that are correctly identified) of SDCT versus conventional CT scanning or characterizing carotid atherosclerotic plaque components(One Year)
- Change in specificity (measures the proportion of negatives that are correctly identified) of SDCT versus conventional CT scanning or characterizing carotid atherosclerotic plaque components(One Year)
- Change in sensitivity (measures the proportion of positives that are correctly identified) of SDCT versus conventional CT scanning for characterizing pulmonary nodules.(One Year)