Clinical Validation Study of Multi-EPI Mix
- Conditions
- Brain Diseases
- Registration Number
- NCT03338270
- Lead Sponsor
- Karolinska University Hospital
- Brief Summary
This study aims to assess the diagnostic validity of a new minute-MRI sequence for neuroradiological evaluation in comparison to conventional MRI.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- Neuroradiological MRI
- Aborted exam
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic potential 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
- Secondary Outcome Measures
Name Time Method Lesion classification At MRI scan Classification into disease categories
Multifocality At MRI scan Determine multifocal lesion
Lesion description At MRI scan For example effect on brain parenchyma and size
Lesion location determination At MRI scan Anatomical localization of abnormality
Ability to rule out diseases At MRI scan A list of diseases
Brain coverage At MRI scan Full or lower
Imaging quality At MRI scan Artefacts
Diagnostic imaging quality At MRI scan Diagnostic imaging quality
Diagnostic confidence At MRI scan Scale
Anatomical conspicuity At MRI scan Specified anatomical structures
Clinical diagnostic summay report At MRI scan Text
Trial Locations
- Locations (1)
Karolinska University Hospital
🇸🇪Stockholm, Sweden