Is Eovist Suitable for Arterial-Phase MR Imaging of Liver

Liver Disease Clinical Trial

Official title:

Is Eovist Suitable for Arterial-Phase MR Imaging of Liver

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02684526
• Other study ID #: HUM00038856
• Status: Completed
• Phase: N/A
• First received: March 14, 2013
• Last updated: December 15, 2016
• Start date: December 2011
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Liver Disease
• Liver Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Adverse events (including dyspnea)	Number of patients complaining of adverse events after MRI contrast administration.	30 min	Yes