Unilateral Meniere Disease: Can Double Dose Gadolinium and Delayed Imaging Make the Diagnosis?
Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Meniere Disease
Intervention: Gadopentetate dimeglumine (Drug)
Phase: N/A
Status: Enrolling by invitation
Sponsored by: Emory University Official(s) and/or principal investigator(s): Patricia Hudgins, MD, Principal Investigator, Affiliation: Emory University
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.
Clinical Details
Official title: Diagnosing Endolymphatic Hydrops in Patients With Meniere Disease Using Magnetic Resonance Imaging With Intravenous Gadolinium Administration
Study design: Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Primary outcome: Grade of endolymphatic hydrops (EH) in the cochlea and vestibule
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Emory University Department of Otolaryngology Clinic, Atlanta, Georgia 30308, United States
Additional Information
Starting date: February 2015
Last updated: February 19, 2015
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