Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Meniere's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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intratympanic injection

Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.

Group Type EXPERIMENTAL

Magnevist (gadopentetate dimeglumine)

Intervention Type DRUG

Interventions

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Magnevist (gadopentetate dimeglumine)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Symptoms and clinical exam consistent with Ménière's disease
* Ability to undergo MR exam
* Interest in participating in this study
* Ability to provide informed consent

Exclusion Criteria

* Children (under age 18),
* Contraindication to MR imaging (see attached UCSD MR Screening Form)
* Claustrophobia precluding MR exam without sedation
* Contraindication to receiving intravenous gadolinium-based contrast agent (see attached UCSD Contrast Policy)
* Patients who are pregnant or breast feeding (intravenous contrast agents are Category C)
* Contraindication to osmotic challenge (congestive heart failure, renal failure, hepatic failure)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No