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

Meniere Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02371798
• Other study ID #: IRB00077659
• Status: Withdrawn
• Phase: N/A
• First received: February 19, 2015
• Last updated: November 30, 2016
• Start date: February 2015
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Meniere Disease

Intervention

Drug:
• Gadopentetate dimeglumine
IV administration of 0.2 mmol/kg of Gd-DTPA

Locations

Country	Name	City	State
United States	Emory University Department of Otolaryngology Clinic	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No