Clinical Validation Study of Multi-EPI Mix

Brain Diseases Clinical Trial

Official title:

Clinical Validation Study of a Novel Minute MRI Sequence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03338270
• Other study ID #: Neuroradiology Karolinska Uni.
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: May 7, 2018

Study information

• Verified date: October 2018
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: May 7, 2018
• Est. primary completion date: May 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Neuroradiological MRI

Exclusion Criteria:

• Aborted exam

Related Conditions & MeSH terms

• Brain Diseases

Intervention

Diagnostic Test:
• MRI
MRI sequence without intravenous contrast

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	GE Healthcare

Country where clinical trial is conducted

Sweden, 

Outcome

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