Clinical Validation Study of Multi-EPI Mix

NCT ID: NCT03338270

Last Updated: 2018-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-05-07

Brief Summary

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

Detailed Description

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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.

Conditions

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Brain Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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MRI

MRI sequence without intravenous contrast

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

\- Neuroradiological MRI

Exclusion Criteria

\- Aborted exam
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anna Falk Delgado

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Falk Delgado, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Neuroscience

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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Delgado AF, Kits A, Bystam J, Kaijser M, Skorpil M, Sprenger T, Skare S. Diagnostic performance of a new multicontrast one-minute full brain exam (EPIMix) in neuroradiology: A prospective study. J Magn Reson Imaging. 2019 Dec;50(6):1824-1833. doi: 10.1002/jmri.26742. Epub 2019 Apr 1.

Reference Type DERIVED
PMID: 30932287 (View on PubMed)

Other Identifiers

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Neuroradiology Karolinska Uni.

Identifier Type: -

Identifier Source: org_study_id

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