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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02186054
Other study ID # T2 Weighted MRI Liver
Secondary ID
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


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
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