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临床试验/NCT03338270
NCT03338270已完成不适用

Clinical Validation Study of a Novel Minute MRI Sequence

Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
101
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 validity of a new minute-MRI sequence for neuroradiological evaluation in comparison to conventional MRI.

详细描述

The study aims to assess the imaging quality 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 the AUC for diagnostic performance of minute MRI compared to conventional MRI.

Included patients are those with suspiscion of cerebral pathology.

Study participancts are investigated at 3T.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Neuroradiological MRI

排除标准

  • Aborted exam

结局指标

主要结局

Diagnostic potential

时间窗: At MRI scan. Diagnostic accuracy to categorize scan as normal or abnormal on a five point Likert scale compared to abnormal/normal conventional MRI.

Diagnostic performance of lesion conspicuity of new MR sequence compared to conventional sequences

次要结局

  • Ability to rule out diseases(At MRI scan)
  • Brain coverage(At MRI scan)
  • Diagnostic imaging quality(At MRI scan)
  • Lesion classification(At MRI scan)
  • Multifocality(At MRI scan)
  • Lesion description(At MRI scan)
  • Lesion location determination(At MRI scan)
  • Diagnostic confidence(At MRI scan)
  • Imaging quality(At MRI scan)
  • Anatomical conspicuity(At MRI scan)
  • Clinical diagnostic summay report(At MRI scan)

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Falk Delgado

Principal Investigator

Karolinska University Hospital

研究点 (1)

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