Back to resultsT2 Weighted Imaging of the Liver With Fast Spin Echo MRI
Primary Purpose
Liver Disease
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MRI examinations
Sponsored by
About this trial
This is an interventional diagnostic trial for Liver Disease focused on measuring Abdominal-Pelvic MRI (magnetic resonance image), T2W (T2 weighted), FSE Flex (recently developed MRI pulse sequence), Enhanced single shot FSE (fast spin echo).
Eligibility Criteria
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
Sites / Locations
- Ottawa Hospital (Civic Campus)
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Imaging- MRI examinations
Arm Description
Liver MRI imaging will be performed on 50 patients.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02186054
First Posted
July 4, 2014
Last Updated
November 17, 2015
Sponsor
Ottawa Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02186054
Brief Title
T2 Weighted Imaging of the Liver With Fast Spin Echo MRI
Official Title
Enhancement of T2 Weighted Imaging of the Liver With Fast Spin Echo Magnetic Resonance Imaging (MRI).
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
Trial Logistics
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease
Keywords
Abdominal-Pelvic MRI (magnetic resonance image), T2W (T2 weighted), FSE Flex (recently developed MRI pulse sequence), Enhanced single shot FSE (fast spin echo).
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Imaging- MRI examinations
Arm Type
Other
Arm Description
Liver MRI imaging will be performed on 50 patients.
Intervention Type
Device
Intervention Name(s)
MRI examinations
Other Intervention Name(s)
MRI, FSE Flex, Enhanced single shot FSE (eSSFSE)
Intervention Description
Consented patients will be required to stay in the MRI scanner to complete the 2 additional sequences once their standard exam is completed.
Primary Outcome Measure Information:
Title
The number of abdominal MRI scans deemed improved quality
Description
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.
Time Frame
Regular scan time with one of 4 clinical scanners plus 3 additional minutes
Secondary Outcome Measure Information:
Title
The number of MRI scans that display severity of imaging artifact
Description
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.
Time Frame
Regular scan time with one of 4 clinical scanners plus 3 additional minutes
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Schieda, MD
Organizational Affiliation
OHRI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ottawa Hospital (Civic Campus)
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
T2 Weighted Imaging of the Liver With Fast Spin Echo MRI
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