NCT03338270

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
22 days until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2018

Completed
Last Updated

October 5, 2018

Status Verified

October 1, 2018

Enrollment Period

5 months

First QC Date

November 7, 2017

Last Update Submit

October 3, 2018

Conditions

Brain Diseases

Keywords

MRINeuroradiologyminute-MRImulti EPI-mixClinical Validation

Outcome Measures

Primary Outcomes (1)

  • Diagnostic potential

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

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

Secondary Outcomes (11)

  • Lesion location determination

    At MRI scan

  • Lesion classification

    At MRI scan

  • Imaging quality

    At MRI scan

  • Diagnostic imaging quality

    At MRI scan

  • Anatomical conspicuity

    At MRI scan

  • +6 more secondary outcomes

Interventions

MRIDIAGNOSTIC_TEST

MRI sequence without intravenous contrast

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Neuroradiological indication for brain MRI

You may qualify if:

  • \- Neuroradiological MRI

You may not qualify if:

  • \- Aborted exam

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 30932287DERIVED

MeSH Terms

Conditions

Brain Diseases

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Study Officials

  • Anna Falk Delgado, MD, PhD

    Clinical Neuroscience

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 7, 2017

First Posted

November 9, 2017

Study Start

December 1, 2017

Primary Completion

May 7, 2018

Study Completion

May 7, 2018

Last Updated

October 5, 2018

Record last verified: 2018-10

Locations

SE(1)