Overview

This trial is active, not recruiting.

Condition liver disease
Treatments eovist contrast, non eovist contrast
Sponsor University of Michigan
Start date December 2011
End date August 2016
Trial size 100 participants
Trial identifier NCT02684526, HUM00038856

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose basic science
Arm
(Active Comparator)
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.
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)
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.
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.

Primary Outcomes

Measure
Scanning artifacts on MRI with Eovist
time frame: 5 years

Secondary Outcomes

Measure
Adverse events (including dyspnea)
time frame: 30 min

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Is Eovist Suitable for Arterial-Phase MR Imaging of Liver
Principal investigator Hero Hussain, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University of Michigan.