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Clinical Validation Study of Multi-EPI Mix

Clinical Validation Study of a Novel Minute MRI Sequence

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03338270
Enrollment
101
Registered
2017-11-09
Start date
2017-12-01
Completion date
2018-05-07
Last updated
2018-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Diseases

Keywords

MRI, Neuroradiology, minute-MRI, multi EPI-mix, Clinical Validation

Brief summary

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

Interventions

DIAGNOSTIC_TESTMRI

MRI sequence without intravenous contrast

Sponsors

GE Healthcare
CollaboratorINDUSTRY
Karolinska University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

\- Neuroradiological MRI

Exclusion criteria

\- Aborted exam

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic potentialAt 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

MeasureTime frameDescription
Lesion classificationAt MRI scanClassification into disease categories
Imaging qualityAt MRI scanArtefacts
Diagnostic imaging qualityAt MRI scanDiagnostic imaging quality
Anatomical conspicuityAt MRI scanSpecified anatomical structures
MultifocalityAt MRI scanDetermine multifocal lesion
Lesion location determinationAt MRI scanAnatomical localization of abnormality
Lesion descriptionAt MRI scanFor example effect on brain parenchyma and size
Diagnostic confidenceAt MRI scanScale
Brain coverageAt MRI scanFull or lower
Clinical diagnostic summay reportAt MRI scanText
Ability to rule out diseasesAt MRI scanA list of diseases

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026