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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02371798
Other study ID # IRB00077659
Secondary ID
Status Withdrawn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Status Withdrawn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


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
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