Clinical Trial: Unilateral Meniere Disease: Can Double Dose Gadolinium and Delayed Imaging Make the Diagnosis?

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Diagnosing Endolymphatic Hydrops in Patients With Meniere Disease Using Magnetic Resonance Imaging With Intravenous Gadolinium Administration

Brief Summary: The purpose of this research study is to see if magnetic resonance imaging (MRI) with a double dose of contrast, or dye, and delayed imaging with MRI can help to diagnose Meniere Disease.

Detailed Summary: Meniere's disease (MD) is a medical condition causing attacks of vertigo, ringing in the ears, hearing loss and often a fullness in the ear. Currently there is no definitive test to diagnose the problem. It is believed to be caused by inner ear abnormalities, specifically of an over-collection of lymphatic fluid.The goal of this trial is to determine if an MRI with double dose of IV gadolinium can be diagnostic.
Sponsor: Emory University

Current Primary Outcome: Grade of endolymphatic hydrops (EH) in the cochlea and vestibule [ Time Frame: 6 hours after intravenous contrast injection ]

Two Certificate of Added Qualifications (CAQ)-certified neuroradiologists will evaluate the MRI findings. The degree of EH in the vestibule and cochlea will be classified as "none", "grade I" and "grade II," with grade I being defined as mild and grade II being defined as significant.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Emory University

Dates:
Date Received: February 19, 2015
Date Started: February 2015
Date Completion:
Last Updated: November 30, 2016
Last Verified: November 2016