Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent
Information source: University of California, San Diego
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Meniere's Disease
Intervention: Magnevist (gadopentetate dimeglumine) (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of California, San Diego
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.
Clinical Details
Official title: Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: relative volume of endolymphatic space to perilymphatic space
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
UC San Diego Health System, San Diego, California 92103, United States
Additional Information
Starting date: January 2012
Last updated: March 8, 2014
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