Back to resultsMagnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent
Primary Purpose
Meniere's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnevist (gadopentetate dimeglumine)
Sponsored by
About this trial
This is an interventional diagnostic trial for Meniere's Disease focused on measuring Meniere's disease, endolymphatic hydrops
Eligibility 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)
Sites / Locations
- UC San Diego Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intratympanic injection
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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)
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02080312
First Posted
March 3, 2014
Last Updated
February 11, 2016
Sponsor
University of California, San Diego
Collaborators
American Society of Head and Neck Radiology
1. Study Identification
Unique Protocol Identification Number
NCT02080312
Brief Title
Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent
Official Title
Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
American Society of Head and Neck Radiology
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere's Disease
Keywords
Meniere's disease, endolymphatic hydrops
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intratympanic injection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Magnevist (gadopentetate dimeglumine)
Primary Outcome Measure Information:
Title
Vestibular "Endolymphatic Hydrops (EH)"
Description
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
Title
Cochlear "Endolymphatic Hydrops (EH)"
Description
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 Outcome Measure Information:
Title
Extension of Contrast From Perilymph to CSF
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
UC San Diego Health System
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25814661
Citation
Bykowski J, Harris JP, Miller M, Du J, Mafee MF. Intratympanic Contrast in the Evaluation of Meniere Disease: Understanding the Limits. AJNR Am J Neuroradiol. 2015 Jul;36(7):1326-32. doi: 10.3174/ajnr.A4277. Epub 2015 Mar 26.
Results Reference
result
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Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent
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