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

University of California San Diego

Status: Completed

Conditions: Meniere's Disease

Treatments: Drug: Magnevist (gadopentetate dimeglumine)

Study type: Interventional

Funder types: Other

Identifiers

NCT02080312

115,342 (Other Identifier)

120004

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

intratympanic injection

Experimental group

Description:

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.

Treatment:

Drug: Magnevist (gadopentetate dimeglumine)