Meniere's Disease Clinical Trial
Official title:
Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent
This is a pilot study of patients with clinical symptoms of Ménière's disease using
injection of diluted magnetic resonance imaging (MRI) contrast agent into the ear to
evaluate inner ear structures.
The goal is to reproduce imaging findings described by non-United States (US) institutions,
improve on image quality with decreased scan time and evaluate the dynamics of the contrast
movement into the inner ear structures.
Participants will be scheduled for study sessions on 2 consecutive days to include consent,
baseline audiometric evaluation, intra-tympanic contrast administration, serial MR imaging,
and follow-up audiometry evaluation in the injected ear.
Participants over 59 years old or who have medical conditions will have a blood test to
check kidney function to ensure they can safely receive the contrast.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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