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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: University of California, San Diego

Current Primary Outcome:

  • 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.
  • 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)


Original Primary Outcome: relative volume of endolymphatic space to perilymphatic space [ Time Frame: within 24 hours post injection ]

Current Secondary Outcome: 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.


Original Secondary Outcome:

Information By: University of California, San Diego

Dates:
Date Received: March 3, 2014
Date Started: January 2012
Date Completion:
Last Updated: February 11, 2016
Last Verified: February 2016