Trials / Completed
CompletedNCT02080312
Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- University of California, San Diego · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Magnevist (gadopentetate dimeglumine) |
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2013-12-01
- Completion
- 2013-12-01
- First posted
- 2014-03-06
- Last updated
- 2016-02-12
- Results posted
- 2016-02-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02080312. Inclusion in this directory is not an endorsement.