Is Eovist Suitable for Arterial-Phase MR Imaging of Liver
1 other identifier
interventional
198
1 country
1
Brief Summary
To examine the quality of liver images produced when the contrast agent Eovist is used during MRI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 14, 2013
CompletedFirst Posted
Study publicly available on registry
February 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedDecember 16, 2016
October 1, 2016
4.7 years
March 14, 2013
December 15, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Scanning artifacts on MRI with Eovist
To qualitatively assess and score MRI images during unenhanced and contrast-enhanced motion-sensitive sequences for breathing artifacts when Eovist contrast is used versus other contrast agents. Eovist enhanced MRI scans will be compared to previous MRI scans performed with other contrast agents on the same patient that included breath holding sequences. Breathing artifacts on both scans will be evaluated using a respiratory motion score between 1 and 5.
5 years
Secondary Outcomes (1)
Adverse events (including dyspnea)
30 min
Study Arms (2)
Eovist Contrast agent
ACTIVE COMPARATORTo determine if Eovist contrast agent induces a transient abnormal sensation at first pass, which prevents patients from holding their breath at end of arterial phase liver MRI scans.
Non Eovist Contrast agents
ACTIVE COMPARATORTo determine if using non-Eovist contrast agents produce the same abnormal sensation at first pass, which prevents patients from holding their breath at end of arterial phase liver MRI scans. Determine if this event is exclusive to Eovist contrast.
Interventions
Subjects will undergo an MRI (magnetic resonance imaging) scan using the Eovist contrast agent. This MRI scan takes approximately 45minutes to 1 hour to complete.
Subjects will undergo an MRI (magnetic resonance imaging) scan using a contrast agent other than Eovist. This MRI scan takes approximately 45minutes to 1 hour to complete.
Eligibility Criteria
You may qualify if:
- You have had a scheduled MRI(magnetic resonance imaging) scan using the contrast agent EOVIST.
- Male and females 21 years of age or older.
You may not qualify if:
- Does not have a contraindication for MRI (e.g. cardiac pacemaker, ferromagnetic or metallic implants).
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan Hospital
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hero Hussain, M.D.
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 14, 2013
First Posted
February 18, 2016
Study Start
December 1, 2011
Primary Completion
August 1, 2016
Study Completion
October 1, 2016
Last Updated
December 16, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share