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

Primary Purpose

Meniere Disease

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Gadopentetate dimeglumine

Sponsored by

Emory University

About this trial

This is an interventional diagnostic trial for Meniere Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Emory University Department of Otolaryngology Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Double dose of Gadopentetate dimeglumine

Arm Description

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

First Posted

February 19, 2015

Last Updated

November 30, 2016

Sponsor

Emory University

1. Study Identification

Unique Protocol Identification Number

NCT02371798

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Withdrawn

Study Start Date

February 2015 (undefined)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meniere Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Double dose of Gadopentetate dimeglumine

Arm Type

Experimental

Arm Description

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)

Intervention Type

Drug

Intervention Name(s)

Gadopentetate dimeglumine

Other Intervention Name(s)

Magnevist, Gadopentetic acid

Intervention Description

IV administration of 0.2 mmol/kg of Gd-DTPA

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

6 hours after intravenous contrast injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patricia Hudgins, MD

Organizational Affiliation

Emory University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emory University Department of Otolaryngology Clinic

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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