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

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Meniere Disease

Intervention / Treatment
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* Drug: Gadopentetate dimeglumine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Double dose of Gadopentetate dimeglumine<br>Subjects with a clinical diagnosis of unilateral Meniere Disease (MD) will undergo 3T MR imaging with a double dose of intravenous (IV) gadolinium contrast injection: 0.2 mmol/kg of Gd-DTPA (Magnevist) | Drug: Gadopentetate dimeglumine<br>* IV administration of 0.2 mmol/kg of Gd-DTPA<br>* Other names: Gadopentetic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 hours after intravenous contrast injection |