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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

Page last updated: August 23, 2015

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