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

NCT02371798 | Withdrawn

• 1 other identifier: IRB00077659
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Meniere Disease

Outcome Measures

Primary Outcomes (1)

• Grade of endolymphatic hydrops (EH) in the cochlea and vestibule

  Two Certificate of Added Qualifications (CAQ)-certified neuroradiologists will evaluate the MRI findings. The degree of EH in the vestibule and cochlea will be classified as "none", "grade I" and "grade II," with grade I being defined as mild and grade II being defined as significant.

  6 hours after intravenous contrast injection

Study Arms (1)

Double dose of Gadopentetate dimeglumine

EXPERIMENTAL

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)

Drug: Gadopentetate dimeglumine

Interventions

Gadopentetate dimeglumine DRUG

IV administration of 0.2 mmol/kg of Gd-DTPA

Also known as: Magnevist, Gadopentetic acid

Double dose of Gadopentetate dimeglumine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University Department of Otolaryngology Clinic

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Conditions

Meniere Disease

Interventions

Gadolinium DTPA

Condition Hierarchy (Ancestors)

Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pentetic Acid; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Coordination Complexes

Study Officials

• Patricia Hudgins, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: February 26, 2015
• Study Start: February 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 1, 2016

Record last verified: 2016-11

Locations

US (1)