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Completed

NCT Number: NCT02684526

Is Eovist Suitable for Arterial-Phase MR Imaging of Liver

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

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Key information

Conditions

Liver Disease Digestive System Diseases Liver Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eovist Contrast

Procedure

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.

Non Eovist Contrast

Procedure

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

  1. Scanning artifacts on MRI with Eovist

    Time frame: 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 outcomes

  1. Adverse events (including dyspnea)

    Time frame: 30 min

    Number of patients complaining of adverse events after MRI contrast administration.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Feb 18, 2016
Registry last updated
Dec 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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