EPIMix (Echo Planar Imaging Mix) Versus CT Brain Pediatric Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Diagnostic potential
研究概览
简要总结
This study aims to assess the diagnostic feasibility and diagnostic performance of a new fast MR sequence EPIMix for neuroradiological evaluation in comparison to computed tomography of brain in pediatric population.
详细描述
The study aims to assess the feasibility of fast MR sequence for neuroradiological evaluation in comparison to computed tomography of brain in pediatric population. Imaging quality is analysed with regards to artefacts and lesion conspicuity as well as its diagnostic potential in rendering a probable diagnosis. The primary study aim is to define feasibility and the AUC for diagnostic performance of minute MRI compared to computed tomography.
Included patients are children age 4-18 with suspicion of cerebral pathology with referral to elective computed tomography of the brain.
Study participants are in addition to computed tomography investigated during same day at 3T MR.
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
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 4-18 years.
- •Patient with suspicion of cerebral pathology.
- •Referral to elective brain CT study.
排除标准
- •CT planned with sedation
- •known previous cerebral pathology (follow up study)
- •Emergency CT
- •Aborted MR exam
结局指标
主要结局
Diagnostic potential
时间窗: At 0 hours
Diagnostic accuracy to categorize scan as normal or abnormal on a five point Likert scale (1 - definitely normal, 2 - Probably normal, 3 - Indeterminate, 4 - Probably abnormal, 5 - Definitely abnormal) compared to abnormal/normal brain CT.
Tolerance of a new fast MR method in children
时间窗: At 0 hours
Number of aborted MR
次要结局
- Artefacts(At 0 hours)
- Lesion classification(At 0 hours)
- Lesion location determination(At 0 hours)
- Lesion description(At 0 hours)
- Clinical diagnostic summary report(At 0 hours)
- Diagnostic imaging quality(At 0 hours)
- Diagnostic confidence(At 0 hours)
- Ability to rule out diseases(At 0 hours)
研究者
Anna Falk Delgado
Principal Investigator, Medical doctor, PhD, Specialist in Neuroradiology
Karolinska University Hospital