Clinical Validation Study of Multi-EPI Mix

October 3, 2018 updated by: Anna Falk Delgado, Karolinska University Hospital

Clinical Validation Study of a Novel Minute MRI Sequence

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Neuroradiological indication for brain MRI

Description

Inclusion Criteria:

- Neuroradiological MRI

Exclusion Criteria:

- Aborted exam

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesion location determination
Time Frame: At MRI scan
Anatomical localization of abnormality
At MRI scan
Lesion classification
Time Frame: At MRI scan
Classification into disease categories
At MRI scan
Imaging quality
Time Frame: At MRI scan
Artefacts
At MRI scan
Diagnostic imaging quality
Time Frame: At MRI scan
Diagnostic imaging quality
At MRI scan
Anatomical conspicuity
Time Frame: At MRI scan
Specified anatomical structures
At MRI scan
Multifocality
Time Frame: At MRI scan
Determine multifocal lesion
At MRI scan
Ability to rule out diseases
Time Frame: At MRI scan
A list of diseases
At MRI scan
Lesion description
Time Frame: At MRI scan
For example effect on brain parenchyma and size
At MRI scan
Diagnostic confidence
Time Frame: At MRI scan
Scale
At MRI scan
Brain coverage
Time Frame: At MRI scan
Full or lower
At MRI scan
Clinical diagnostic summay report
Time Frame: At MRI scan
Text
At MRI scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

GE Healthcare

Investigators

  • Principal Investigator: Anna Falk Delgado, MD, PhD, Clinical Neuroscience

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2017

Primary Completion (ACTUAL)

May 7, 2018

Study Completion (ACTUAL)

May 7, 2018

Study Registration Dates

First Submitted

November 7, 2017

First Submitted That Met QC Criteria

November 7, 2017

First Posted (ACTUAL)

November 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 5, 2018

Last Update Submitted That Met QC Criteria

October 3, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neuroradiology Karolinska Uni.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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