DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Unilateral Meniere Disease: Can Double Dose Gadolinium and Delayed Imaging Make the Diagnosis?

Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Meniere Disease

Intervention: Gadopentetate dimeglumine (Drug)

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Emory University

Official(s) and/or principal investigator(s):
Patricia Hudgins, MD, Principal Investigator, Affiliation: Emory University

Summary

The purpose of this research study is to see if magnetic resonance imaging (MRI) with a double dose of contrast, or dye, and delayed imaging with MRI can help to diagnose Meniere Disease.

Clinical Details

Official title: Diagnosing Endolymphatic Hydrops in Patients With Meniere Disease Using Magnetic Resonance Imaging With Intravenous Gadolinium Administration

Study design: Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Primary outcome: Grade of endolymphatic hydrops (EH) in the cochlea and vestibule

Detailed description: Meniere's disease (MD) is a medical condition causing attacks of vertigo, ringing in the ears, hearing loss and often a fullness in the ear. Currently there is no definitive test to diagnose the problem. It is believed to be caused by inner ear abnormalities, specifically of an over-collection of lymphatic fluid. The goal of this trial is to determine if an MRI with double dose of IV gadolinium can be diagnostic.

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of unilateral Meniere Disease (MD) per the Committee on Hearing and

Equilibrium of the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS)

- Glomerular filtration rate (GFR) > 90 mls/min/1. 73 m2

- Creatinine (Cr) level serum < 1. 6 mg/dl

Exclusion Criteria:

- Age < 18 years

- Diagnosis of bilateral MD

- History of prior temporal bone surgery

- History of cochlear implant placement

- Pacemaker, cardiac implantable electronic device, shrapnel, aneurysm clips or other

metal objects that are prohibited in the MR suite

- GFR < 90 mls/min/1. 73m2

- Cr level > 1. 6 mg/d

- Lack of IV access

- Contrast allergy to gadolinium agent

- Pregnancy

- Claustrophobia necessitating parenteral anxiolytics

- Patients who are unable to provide informed consent for themselves

Locations and Contacts

Emory University Department of Otolaryngology Clinic, Atlanta, Georgia 30308, United States
Additional Information

Starting date: February 2015
Last updated: February 19, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017