N/A N=6 Diagnostic

Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent

Meniere's Disease

Bottom Line

View on ClinicalTrials.gov: NCT02080312 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2016

Primary outcome: Primary: Vestibular "Endolymphatic Hydrops (EH)" — 0; 4; 2 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Magnevist (gadopentetate dimeglumine) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, San Diego
Primary completion: Dec 2013

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	—

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.

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)

View full record on ClinicalTrials.gov →

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.