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Completed

NCT Number: NCT03338270

Clinical Validation Study of Multi-EPI Mix

This study aims to assess the diagnostic validity of a new minute-MRI sequence for neuroradiological evaluation in comparison to conventional MRI.

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Key information

Conditions

Brain Diseases Central Nervous System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Neuroradiological MRI

Exclusion criteria

  • Aborted exam

Treatment and study plan

MRI

Diagnostic Test

MRI sequence without intravenous contrast

Primary outcomes

  1. Diagnostic potential

    Time frame: 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 outcomes

  1. Lesion location determination

    Time frame: At MRI scan

    Anatomical localization of abnormality

  2. Lesion classification

    Time frame: At MRI scan

    Classification into disease categories

  3. Imaging quality

    Time frame: At MRI scan

    Artefacts

  4. Diagnostic imaging quality

    Time frame: At MRI scan

    Diagnostic imaging quality

  5. Anatomical conspicuity

    Time frame: At MRI scan

    Specified anatomical structures

  6. Multifocality

    Time frame: At MRI scan

    Determine multifocal lesion

  7. Ability to rule out diseases

    Time frame: At MRI scan

    A list of diseases

  8. Lesion description

    Time frame: At MRI scan

    For example effect on brain parenchyma and size

  9. Diagnostic confidence

    Time frame: At MRI scan

    Scale

  10. Brain coverage

    Time frame: At MRI scan

    Full or lower

  11. Clinical diagnostic summay report

    Time frame: At MRI scan

    Text

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • GE Healthcare

Registry information

Official study title

Clinical Validation Study of a Novel Minute MRI Sequence

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 9, 2017
Registry last updated
Oct 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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