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

Not Applicable

Withdrawn

• Conditions: Meniere Disease
• Interventions: Drug: Gadopentetate dimeglumine

• Registration Number: NCT02371798
• Lead Sponsor: Emory University

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 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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-19
• Study First Submitted QC: 2015-02-19
• Study First Posted: 2015-02-26
• Status Verified: 2016-11
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2016-11-30
• Last Update Posted: 2016-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Double dose of Gadopentetate dimeglumine	Gadopentetate dimeglumine	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)

Primary Outcome Measures

Name	Time	Method
Grade of endolymphatic hydrops (EH) in the cochlea and vestibule	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.

Trial Locations

Locations (1)

Emory University Department of Otolaryngology Clinic; 🇺🇸 Atlanta, Georgia, United States