Is Eovist Suitable for Arterial-Phase MR Imaging of Liver

Study Overview
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Brief Summary
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To examine the quality of liver images produced when the contrast agent Eovist is used during MRI.

Detailed Description
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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.

Official Title
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Is Eovist Suitable for Arterial-Phase MR Imaging of Liver

Conditions
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Liver Disease

Intervention / Treatment
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* Procedure: Eovist Contrast
* Procedure: Non Eovist Contrast


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Eovist Contrast agent<br>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. | Procedure: Eovist Contrast<br>* 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.<br>|
| Active Comparator: Non Eovist Contrast agents<br>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. | Procedure: Non Eovist Contrast<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (including dyspnea) | Number of patients complaining of adverse events after MRI contrast administration. | 30 min |