NCT02186054

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

2 years

First QC Date

July 4, 2014

Last Update Submit

November 17, 2015

Conditions

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).

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • The number of MRI scans that display severity of imaging artifact

    Regular scan time with one of 4 clinical scanners plus 3 additional minutes

Study Arms (1)

Imaging- MRI examinations

OTHER

Liver MRI imaging will be performed on 50 patients.

Device: MRI examinations

Interventions

MRI examinationsDEVICE

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

Also known as: MRI, FSE Flex, Enhanced single shot FSE (eSSFSE)
Imaging- MRI examinations

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients not undergoing routine liver MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ottawa Hospital (Civic Campus)

Ottawa, Ontario, K1Y 4E9, Canada

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Nick Schieda, MD

    OHRI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2014

First Posted

July 10, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

November 18, 2015

Record last verified: 2015-11

Locations

CA(1)