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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02371798

Enrollment

Registered

2015-02-26

Start date

2015-02-28

Completion date

2016-11-30

Last updated

2016-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meniere Disease

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.

Interventions

DRUGGadopentetate dimeglumine

IV administration of 0.2 mmol/kg of Gd-DTPA

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026