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Trial record 8 of 95 for:    gadobenate dimeglumine

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

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ClinicalTrials.gov Identifier: NCT02371798
Recruitment Status : Withdrawn
First Posted : February 26, 2015
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Patricia Hudgins, Emory University

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.

Condition or disease Intervention/treatment Phase
Meniere Disease Drug: Gadopentetate dimeglumine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Diagnosing Endolymphatic Hydrops in Patients With Meniere Disease Using Magnetic Resonance Imaging With Intravenous Gadolinium Administration
Study Start Date : February 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

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Arm Intervention/treatment
Experimental: Double dose of Gadopentetate dimeglumine
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
IV administration of 0.2 mmol/kg of Gd-DTPA
Other Names:
  • Magnevist
  • Gadopentetic acid




Primary Outcome Measures :
  1. Grade of endolymphatic hydrops (EH) in the cochlea and vestibule [ Time Frame: 6 hours after intravenous contrast injection ]
    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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02371798


Locations
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United States, Georgia
Emory University Department of Otolaryngology Clinic
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Patricia Hudgins, MD Emory University

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Responsible Party: Patricia Hudgins, Professor, Emory University
ClinicalTrials.gov Identifier: NCT02371798     History of Changes
Other Study ID Numbers: IRB00077659
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
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Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases