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Is Eovist Suitable for Arterial-Phase MR Imaging of Liver

Primary Purpose

Liver Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eovist Contrast
Non Eovist Contrast
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Liver Disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. You have had a scheduled MRI(magnetic resonance imaging) scan using the contrast agent EOVIST.
  2. Male and females 21 years of age or older.

Exclusion Criteria:

  1. Does not have a contraindication for MRI (e.g. cardiac pacemaker, ferromagnetic or metallic implants).
  2. Pregnancy

Sites / Locations

  • University of Michigan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Eovist Contrast agent

Non Eovist Contrast agents

Arm Description

To 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.

To 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adverse events (including dyspnea)
Number of patients complaining of adverse events after MRI contrast administration.

Full Information

First Posted
March 14, 2013
Last Updated
December 15, 2016
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02684526
Brief Title
Is Eovist Suitable for Arterial-Phase MR Imaging of Liver
Official Title
Is Eovist Suitable for Arterial-Phase MR Imaging of Liver
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To examine the quality of liver images produced when the contrast agent Eovist is used during MRI.
Detailed Description
Researchers will review data from the Eovist MRI and compare the scan with previous MRI exams the patient had with the same or other contrast agents. To determine the efficacy of Eovist contrast agent in producing MRI images of the liver. We will monitor patients for any unusual symptoms (adverse events) when the contrast is given. Patients are asked to hold their breath during an MRI scan. Eovist may interfere with the "breath hold" which could result in more breathing artifacts (based on a qualitative scale) on arterial images when the patients are given Eovist vs. other contrast agents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eovist Contrast agent
Arm Type
Active Comparator
Arm Description
To 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.
Arm Title
Non Eovist Contrast agents
Arm Type
Active Comparator
Arm Description
To 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.
Intervention Type
Procedure
Intervention Name(s)
Eovist Contrast
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Non Eovist Contrast
Intervention Description
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.
Primary Outcome Measure Information:
Title
Scanning artifacts on MRI with Eovist
Description
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Adverse events (including dyspnea)
Description
Number of patients complaining of adverse events after MRI contrast administration.
Time Frame
30 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: You have had a scheduled MRI(magnetic resonance imaging) scan using the contrast agent EOVIST. Male and females 21 years of age or older. Exclusion Criteria: Does not have a contraindication for MRI (e.g. cardiac pacemaker, ferromagnetic or metallic implants). Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hero Hussain, M.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Is Eovist Suitable for Arterial-Phase MR Imaging of Liver

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