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Double dose of Gadopentetate dimeglumine for Meniere's Disease
N/A
Waitlist Available
Led By Patricia Hudgins, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours after intravenous contrast injection
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
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.
Eligible Conditions
- Meniere's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 hours after intravenous contrast injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours after intravenous contrast injection
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Grade of endolymphatic hydrops (EH) in the cochlea and vestibule
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Double dose of Gadopentetate dimeglumineExperimental Treatment1 Intervention
Subjects with a clinical diagnosis of unilateral Meniere Disease (MD) will undergo 3T MR imaging with a double dose of intravenous (IV) gadolinium contrast injection: 0.2 mmol/kg of Gd-DTPA (Magnevist)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gadopentetic acid
FDA approved
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,701 Previous Clinical Trials
2,604,731 Total Patients Enrolled
Patricia Hudgins, MDPrincipal InvestigatorEmory University
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