Is Eovist Suitable for Arterial-Phase MR Imaging of Liver

Sponsor

University of Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT02684526

Collaborator

(none)

198

Enrollment

Location

Arms

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Liver Disease	Procedure: Eovist Contrast Procedure: Non Eovist Contrast	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

198 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Is Eovist Suitable for Arterial-Phase MR Imaging of Liver

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Eovist Contrast agent 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 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.
Active Comparator: Non Eovist Contrast agents 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 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.

Arm

Intervention/Treatment

Active Comparator: Eovist Contrast agent

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

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.

Active Comparator: Non Eovist Contrast agents

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

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.

Outcome Measures

Primary Outcome Measures

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

Adverse events (including dyspnea) [30 min]
Number of patients complaining of adverse events after MRI contrast administration.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Hospital	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

University of Michigan

Investigators

Principal Investigator: Hero Hussain, M.D., University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hero Hussain, MD, Principal Investigator, University of Michigan

ClinicalTrials.gov Identifier:

NCT02684526

Other Study ID Numbers:

HUM00038856

First Posted:

Feb 18, 2016

Last Update Posted:

Dec 16, 2016

Last Verified:

Oct 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Liver Diseases

Study Results

No Results Posted as of Dec 16, 2016