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Completed

NCT Number: NCT02080312

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.

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Key information

Conditions

Meniere's Disease Ear Diseases Endolymphatic Hydrops Labyrinth Diseases Meniere Disease Otorhinolaryngologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC San Diego Health System

San Diego, California, 92103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Magnevist (gadopentetate dimeglumine)

Drug

Primary outcomes

  1. Vestibular "Endolymphatic Hydrops (EH)"

    Time frame: 24 hours post injection

    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.

  2. Cochlear "Endolymphatic Hydrops (EH)"

    Time frame: 24 hours post injection

    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)

Secondary outcomes

  1. Extension of Contrast From Perilymph to CSF

    Time frame: 24 hours post injection

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • American Society of Head and Neck Radiology

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 6, 2014
Registry last updated
Feb 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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