Diagnosing Endolymphatic Hydrops in Patients With Meniere Disease Using Magnetic Resonance Imaging With Intravenous Gadolinium Administration
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Grade of endolymphatic hydrops (EH) in the cochlea and vestibule
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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)
干预措施: Gadopentetate dimeglumine (Drug)
结局指标
主要结局
Grade of endolymphatic hydrops (EH) in the cochlea and vestibule
时间窗: 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.
次要结局
未报告次要终点
研究者
Patricia Hudgins
Professor
Emory University