- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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San Diego, California, United States, 92103
- UC San Diego Health System
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 hours post injection
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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)
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24 hours post injection
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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24 hours post injection
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Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 120004
- 115,342 (Other Identifier: FDA)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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