N/A
Completed N=6
Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent
Source: ClinicalTrials.gov NCT02080312 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Vestibular "Endolymphatic Hydrops (EH)" — 0; 4; 2 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vestibular "Endolymphatic Hydrops (EH)" |
0; 4; 2 | — |
| PRIMARY Cochlear "Endolymphatic Hydrops (EH)" |
0; 6; 0 | — |
| SECONDARY Extension of Contrast From Perilymph to CSF |
1; 2; 3 | — |
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)
Data sourced from ClinicalTrials.gov (NCT02080312). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.