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

Emory University

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

SINGLE

Conditions

Meniere Disease

Interventions

Gadopentetate dimeglumineDRUG

IV administration of 0.2 mmol/kg of Gd-DTPA

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of unilateral Meniere Disease (MD) per the Committee on Hearing and Equilibrium of the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) * Glomerular filtration rate (GFR) \> 90 mls/min/1.73 m2 * Creatinine (Cr) level serum \< 1.6 mg/dl Exclusion Criteria: * Age \< 18 years * Diagnosis of bilateral MD * History of prior temporal bone surgery * History of cochlear implant placement * Pacemaker, cardiac implantable electronic device, shrapnel, aneurysm clips or other metal objects that are prohibited in the MR suite * GFR \< 90 mls/min/1.73m2 * Cr level \> 1.6 mg/d * Lack of IV access * Contrast allergy to gadolinium agent * Pregnancy * Claustrophobia necessitating parenteral anxiolytics * Patients who are unable to provide informed consent for themselves

Locations (1)

Emory University Department of Otolaryngology Clinic

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Grade of endolymphatic hydrops (EH) in the cochlea and vestibule

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.

Time frame: 6 hours after intravenous contrast injection

Data from ClinicalTrials.gov

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