Preliminary Assessment of the Added Diagnostic Value of Dual Energy Computed Tomography (DECT) Images Using Data Acquired on a Spectral Detector Computed Tomography (SDCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 1
- 主要终点
- Determine if Post-processed SDCT images provide additional diagnostic value over conventional CT datasets.
研究概览
简要总结
Study hypothesis: Post-processed SDCT images provide additional diagnostic value over conventional CT datasets.
The CT examination would be a clinically-necessary, standard-of-care CT performed as per the clinical indication. The protocol and scan parameters for the CT exam will be similar to that of an equivalent scan performed with any other CT scanner. There would be no additional scanner of injection of any drug specifically for the study. The conventional CT images generated by the scanner will be used for clinical purposes as routinely practiced.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a patient scheduled for a clinically indicated CT scan for one or more of the following body regions/organ systems:
- •head and neck
- •body (chest and abdomen/pelvis)
- •cardiovascular structures.
- •these scans may be without contrast, with contrast enhancement, or CT angiograms.
排除标准
- •under the age of 18 years old
- •standard exclusion criteria for CT scans
结局指标
主要结局
Determine if Post-processed SDCT images provide additional diagnostic value over conventional CT datasets.
时间窗: 6 months
Data will be recorded as mean +/- standard deviation for each parameter. Student's t test and Wilcoxon's test will be performed to compare objective and subjective data respectively. In addition, differences on lesion detection and characterization, sensitivity, specificity and accuracy of conventional CT and SDCT images will be compared using a receiver operating curve (ROC) analysis. Additionally, agreement between both readers will be evaluated using Cohen´s kappa test (poor agreement for κ ≤ 0.19; fair agreement for κ = 0.2-0.39; moderate agreement for κ = 0.4-0.59, substantial agreement for κ = 0.6-0.79 and very good agreement for κ = 0.8-1.00; 19). A P value of \<0.05 will be required for statistical significant difference.
次要结局
未报告次要终点