Prospective Observational Study of Diagnostic Accuracy of Dual-Energy-/Multi-Energy-CT for the Detection of Bone Marrow Edema
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy of Dual-Energy/Multi-Energy/Spectral CT to detect bone marrow edema in comparison with MRI as the goldstandard.
研究概览
简要总结
Dual-Energy/Multi-Energy/Spectral-CT can visualize bone marrow edema associated with fractures, however, current scientific evidence is mostly derived from to retrospective analyses. Our prospective study systematically analyzes the diagnostic accuracy of the visualization of bone marrow edema by including patients who are scheduled for a CT scan to exclude or further characterize a fracture. After giving informed consent, the CT scan will be performed using a dose-neutral Dual-Energy-/Multi-Energy-/Spectral-CT acquisition technique. If the patient undergoes MRI of the same region within 7 days, this scan will be used as a gold-standard for bone marrow edema. This will allow the quantification of diagnostic accuracy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •clinical suspicion for a fracture AND
- •indication for CT confirmed by board-certified radiologist ('justified indication' according to German/European radiation protection law) AND
- •patient (is able to give informed consent and) has given informed consent.
排除标准
- •cardiorespiratory instability (as judged by the referring physician)
- •age < 18 years
- •known or suspected pregnancy
- •known bone metastases of a malignant disease
- •known rheumatic disease
- •metal implants in the region to be scanned
- •surgical intervention over the last 12 months in the region to be scanned
- •contraindications for MRI
结局指标
主要结局
Diagnostic Accuracy of Dual-Energy/Multi-Energy/Spectral CT to detect bone marrow edema in comparison with MRI as the goldstandard.
时间窗: MRI of the same region can be used for comparison if performed within 7 days
sensitivity, specificity and positive and negative likelihood ratios will be assessed
次要结局
未报告次要终点