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

NCT ID: NCT02371798

Last Updated: 2016-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-11-30

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.

Conditions

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Meniere Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Double dose of 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)

Group Type EXPERIMENTAL

Gadopentetate dimeglumine

Intervention Type DRUG

IV administration of 0.2 mmol/kg of Gd-DTPA

Interventions

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Gadopentetate dimeglumine

IV administration of 0.2 mmol/kg of Gd-DTPA

Intervention Type DRUG

Other Intervention Names

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Magnevist Gadopentetic acid

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Patricia Hudgins

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patricia Hudgins, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory University Department of Otolaryngology Clinic

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00077659

Identifier Type: -

Identifier Source: org_study_id