Evaluation of Usefulness of Contrast Enhanced MRI in Evaluation of Spine Trauma: Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Confidence level
研究概览
简要总结
Non-contrast MRI with T2 fat suppression has been a useful imaging modality in evaluation spinal trauma.
However, the role of contrast enhancement has not investigated in patients with spinal trauma.
Therefore, this prospective study aims to evaluate the usefulness of contrast enhanced MRI for spinal trauma W/U clinically.
The study hypothesis is that there is no additional gain in addition of contrast enhanced study to routine non-contrast MRI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who provided the informed consent
- •Patients with spinal trauma
- •Patients with age of 19 years or more
排除标准
- •Relative contraindication of MR contrast
- •previous history of any adverse event after injection of magnetic resonance contrast
- •pregnant or breast-feeding state
- •within 2 weeks after liver transplantation
- •epileptic disorder
- •Patients impossible with follow-up period of at least 2 months clinically
- •Patients with severely impaired renal function of estimated glomerular filtration rate (GFR) < 30 mL/min/1.73m2 and/or on dialysis
- •patients with age less than 19 years
结局指标
主要结局
Confidence level
时间窗: 2 months
Confidence level (1, definitely negative; 2, probably negative; 3, equivocal; 4, probably positive; 5, definitely positive) for lesion of spinal body, posterior compartment, soft tissue (posterior ligamentous complex of thoracolumbar spine and discoligamentous complex of cervical spine), spinal cord, and epidural/subdural hematoma/hemorrhage
The rate (%) of change of treatment option between non-surgery vs. surgery, after review of enhanced MRI finding, compared with non-enhanced MRI only
时间窗: 2 months
The rate (%) of change of treatment option between non-surgery vs. surgery, after review of enhanced MRI finding, compared with non-enhanced MRI only
次要结局
- Inter- and intra-reader agreement of confidence level(2 months)
- Diagnostic accuracy of non-enhanced and enhanced MRI(2 months)
研究者
Guen Young Lee
Cinical assistant professor
Seoul National University Bundang Hospital