Meniere Disease Clinical Trial
Official title:
Diagnosing Endolymphatic Hydrops in Patients With Meniere Disease Using Magnetic Resonance Imaging With Intravenous Gadolinium Administration
Verified date | November 2016 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Emory University Department of Otolaryngology Clinic | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
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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