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

Emory University

Status: Withdrawn

Conditions: Meniere Disease

Treatments: Drug: Gadopentetate dimeglumine

Study type: Interventional

Funder types: Other

Identifiers

NCT02371798

IRB00077659

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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0 participants in 1 patient group

Double dose of Gadopentetate dimeglumine

Experimental group

Description:

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)

Treatment:

Drug: Gadopentetate dimeglumine