T2 Weighted Imaging of the Liver With Fast Spin Echo MRI

Liver Disease Clinical Trial

Official title:

Enhancement of T2 Weighted Imaging of the Liver With Fast Spin Echo Magnetic Resonance Imaging (MRI).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02186054
• Other study ID #: T2 Weighted MRI Liver
• Status: Terminated
• Phase: N/A
• First received: July 4, 2014
• Last updated: November 17, 2015
• Start date: June 2014
• Est. completion date: June 2016

Study information

• Verified date: November 2015
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test two new MRI (magnetic resonance imaging) sequences to see how they compare to previously used imaging sequences as they may improve the quality of abdominal MRI.

Description:

• Approximately 50 patients undergoing routine liver MRI in our practice imaged with one of our 4 clinical scanners will undergo our standard liver MRI protocol with the addition of 2 breath-hold sequences (FSE Flex and eSSFSE) only increasing the scan time by approximately 3 minutes.

• Data will be retrieved from examinations that have been performed from the patient's electronic imaging file stored in our picture archiving and communication system (PACS).

• Images will be completely anonymized. No patient identifiers will be available on the images during the analysis.

• Analyses will include the visual assessment of image quality, presence and severity of imaging artifact and other non-invasive imaging outcomes performed by radiologists blinded to patient information and the type of sequence performed. Data will be presented in a Likert type scale (1=poor, 2=suboptimal, 3=average, 4=above average and 5=excellent) and imaging parameters will be compared using the Wilcoxon sign rank test.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients undergoing routine liver MRI imaged with one of our 4 clinical scanners (MR 750W, General Electric, Milwaukee WI)

Exclusion Criteria:

• Patients not undergoing routine liver MRI

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Liver Disease
• Liver Diseases

Intervention

Device:
• MRI examinations
Consented patients will be required to stay in the MRI scanner to complete the 2 additional sequences once their standard exam is completed.

Locations

Country	Name	City	State
Canada	Ottawa Hospital (Civic Campus)	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of abdominal MRI scans deemed improved quality	Data is presented in a Likert type scale (1=poor, 2=suboptimal, 3=average, 4=above average and 5=excellent) and imaging parameters are compared using the Wilcoxon sign rank test.	Regular scan time with one of 4 clinical scanners plus 3 additional minutes	No
Secondary	The number of MRI scans that display severity of imaging artifact	Data is presented in a Likert type scale (1=poor, 2=suboptimal, 3=average, 4=above average and 5=excellent) and imaging parameters are compared using the Wilcoxon sign rank test.	Regular scan time with one of 4 clinical scanners plus 3 additional minutes	No