Clinical Validation Study of Multi-EPI Mix

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03338270
Recruitment Status : Completed
First Posted : November 9, 2017
Last Update Posted : October 5, 2018
GE Healthcare
Information provided by (Responsible Party):
Anna Falk Delgado, 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.

Condition or disease Intervention/treatment
Brain Diseases Diagnostic Test: 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.

Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Clinical Validation Study of a Novel Minute MRI Sequence
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : May 7, 2018
Actual Study Completion Date : May 7, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Diseases

Intervention Details:
  • Diagnostic Test: MRI
    MRI sequence without intravenous contrast

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

  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 ]

  10. Brain coverage [ Time Frame: At MRI scan ]
    Full or lower

  11. Clinical diagnostic summay report [ Time Frame: At MRI scan ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Neuroradiological indication for brain MRI

Inclusion Criteria:

- Neuroradiological MRI

Exclusion Criteria:

- Aborted exam

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03338270

Karolinska University Hospital
Stockholm, Sweden
Sponsors and Collaborators
Karolinska University Hospital
GE Healthcare
Principal Investigator: Anna Falk Delgado, MD, PhD Clinical Neuroscience

Responsible Party: Anna Falk Delgado, Principal Investigator, Karolinska University Hospital Identifier: NCT03338270     History of Changes
Other Study ID Numbers: Neuroradiology Karolinska Uni.
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anna Falk Delgado, Karolinska University Hospital:
multi EPI-mix
Clinical Validation

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases