T2 Weighted Imaging of the Liver With Fast Spin Echo MRI

November 17, 2015 updated by: Ottawa Hospital Research Institute

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

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

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Ottawa Hospital (Civic Campus)

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Imaging- MRI examinations
Liver MRI imaging will be performed on 50 patients.
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.
Other Names:
  • MRI
  • FSE Flex
  • Enhanced single shot FSE (eSSFSE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of abdominal MRI scans deemed improved quality
Time Frame: Regular scan time with one of 4 clinical scanners plus 3 additional minutes
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of MRI scans that display severity of imaging artifact
Time Frame: Regular scan time with one of 4 clinical scanners plus 3 additional minutes
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

Collaborators and Investigators

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

Sponsor

Ottawa Hospital Research Institute

Investigators

  • Principal Investigator: Nick Schieda, MD, OHRI

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

June 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

July 4, 2014

First Submitted That Met QC Criteria

July 4, 2014

First Posted (Estimate)

July 10, 2014

Study Record Updates

Last Update Posted (Estimate)

November 18, 2015

Last Update Submitted That Met QC Criteria

November 17, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T2 Weighted MRI Liver

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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