Is Eovist Suitable for Arterial-Phase MR Imaging of Liver

Not Applicable

Completed

• Conditions: Liver Disease
• Interventions: Procedure: Eovist Contrast; Procedure: Non Eovist Contrast

• Registration Number: NCT02684526
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2013-03-14
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-18
• Primary Completion: 2016-08
• Status Verified: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-12-15
• Last Update Posted: 2016-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eovist Contrast agent	Eovist Contrast	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.
Non Eovist Contrast agents	Non Eovist Contrast	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.

Primary Outcome Measures

Name	Time	Method
Scanning artifacts on MRI with Eovist	5 years	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

Name	Time	Method
Adverse events (including dyspnea)	30 min	Number of patients complaining of adverse events after MRI contrast administration.

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States