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

N/ACompletedNCT02080312

University of California, San Diego6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Meniere's Disease

Interventions

Magnevist (gadopentetate dimeglumine)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

UC San Diego Health System

San Diego, California, United States

Outcomes

Primary Outcomes

Vestibular "Endolymphatic Hydrops (EH)"

The relative volume of the non-enhancing endolymphatic space was visually assessed relative to the enhancing perilymphatic space on delayed post-IT contrast FLAIR MRI sequences and characterized as \<34%, 34-50% or \>50% of endolymphatic/perilymphatic volume.

Time frame: 24 hours post injection

Cochlear "Endolymphatic Hydrops (EH)"

The relative volume of the scala media of the basal turn of the cochlea (non-enhancing endolymph) was visually assessed relative to the scala tympani and scala vestibuli (enhancing perilymph) on delayed post-IT contrast FLAIR MRI sequences. Cases were characterized as: No Cochlear EH (no perceptible distention of the scala media), Cochlear EH (perceptible distention of the scala media), or Absent enhancement (no contrast in the cochlear perilymph)

Time frame: 24 hours post injection

Secondary Outcomes

Extension of Contrast From Perilymph to CSF

The fundus of the internal auditory canal (IAC) was visually inspected to determine if there was conspicuous, subtle, or no enhancement extending in the setting of prior IT contrast injection, indicating permeability of the cochlear modiolus.

Time frame: 24 hours post injection

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.