Fast Brain MRI in Children With Suspected or Confirmed Brain Tumor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Diagnostic performance
研究概览
简要总结
This study aims to assess the diagnostic performance of a new fast MRI sequence named Neuromix compared to routine clinical MRI for brain tumor in pediatric patients
详细描述
The study aims to assess the diagnostic performance of fast MR sequence for the radiological evaluation of brain tumor in comparison to routine clinical MRI (or reference standard) in a pediatric population.
The primary outcome is the depiction and characterization of normal brain, brain tumor pathology and incidental findings.
Sensitivity, specificity, AUC and intra-/ interreader agreement for the diagnostic performance of Neuromix compared to cMRI will be obtained. Correlation of results between methods will be calculated.
Secondary outcomes will also include the assessment of diagnostic image quality and image artifacts.
The study population will consist of subjects aged 0-18 with a suspected or diagnosed brain tumor referred for routine MRI examination of the brain.
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
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 0-18 years.
- •Pediatric subjects with diagnosed or suspected brain tumor
- •Referral routine MRI study.
排除标准
- •MRI planned without sedation
- •Aborted MR exam
- •Unstable patient
结局指标
主要结局
Diagnostic performance
时间窗: Through study completion, an average of 1 year
AUC, area under the curve for the comparison of the new method against the reference standard
次要结局
- Imaging quality(through study completion, an average of 1 year)
- Agreement(through study completion, an average of 1 year)
- Sensitivity(through study completion, an average of 1 year)
- Imaging artifacts(through study completion, an average of 1 year)
- Correlation(through study completion, an average of 1 year)
- Specificity(through study completion, an average of 1 year)
研究者
Anna Falk Delgado
MD, associate professor
Karolinska University Hospital