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

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ClinicalTrials.gov Identifier: NCT02080312
Recruitment Status : Completed
First Posted : March 6, 2014
Results First Posted : February 12, 2016
Last Update Posted : February 12, 2016
Sponsor:
Collaborator:
American Society of Head and Neck Radiology
Information provided by (Responsible Party):
Julie Bykowski, MD, University of California, San Diego

Study Description
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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.


Condition or disease Intervention/treatment Phase
Meniere's Disease Drug: Magnevist (gadopentetate dimeglumine) Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent
Study Start Date : January 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Magnevist (gadopentetate dimeglumine)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02080312


Locations
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United States, California
UC San Diego Health System
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
American Society of Head and Neck Radiology
More Information
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Publications of Results:

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Responsible Party: Julie Bykowski, MD, Assistant Professor, Radiology, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02080312    
Other Study ID Numbers: 120004
115,342 ( Other Identifier: FDA )
First Posted: March 6, 2014    Key Record Dates
Results First Posted: February 12, 2016
Last Update Posted: February 12, 2016
Last Verified: February 2016
Keywords provided by Julie Bykowski, MD, University of California, San Diego:
Meniere's disease
endolymphatic hydrops
Additional relevant MeSH terms:
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Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases