Non Enhanced Labyrinth Imaging for the Detection of Endolymphatic Hydrops in Meniere's Disease "NELI Study"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Kappa coeficient
研究概览
简要总结
This study includes 30 patients with Meniere's disease confirmed with AAO-HNS criteria.
The aim of this study is to compare the new optimized 3D FLAIR sequence developed at our site with a standard 3D FLAIR sequence performed 4h after a single intravenous dose of macrocyclic gadolinium-based contrast agents for the detection of endolymphatic hydrops.
The patients will be explored with the new 3D FLAIR optimized sequence before injection (method to validate) and again 4 hours after contrast media administration with the same sequence 3D FLAIR
详细描述
Meniere's disease (MD) is a pathology of the inner ear defined by episodes of spontaneous vertigo usually accompanied by tinnitus, pressure within the ear and fluctuating sensorineural hearing loss.
Endolymphatic hydrops (EH) is the main pathophysiological substratum of Meniere's disease. Temporal bone MRI has long been used performed to exclude other pathologies mimicking MD, such as vestibular schwannoma or endolymphatic sac tumor.
Currently, delayed 3D-FLAIR sequence is the imaging technique of choice for the diagnosis of endolymphatic hydrops. The endolymphatic space could be assessed on MRI with 3D-FLAIR sequences delayed acquisition after the intravenous administration of gadolinium.
The saccule appears to be the most involved structure in MD. The reproducibility of the hydrops protocols with various MRI scan manufacturers is debatable.
Because endo and peri lymphatic spaces have different biochemical compositions, a new FLAIR 3D sequence on healthy volunteers can be tuned in order to separate endo and peri lymphatic spaces. The hypothesis of the study is that this new method could detect saccular hydrops with the same performances as the standard FLAIR that is done after gadolinium injection.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman
- •older than 18 years old.
- •Uni- or bilateral definite or probable clinical diagnosis of MD based on the AAO-HNS guidelines revised in
- •Patient eligible for having contrast-enhanced MRI.
- •Patient affiliated of beneficiary of health insurance
- •Patient has signed the Informed consent form.
- •Non inclusion criteria:
- •History of other pathology of the inner ear.
- •History of surgery on the middle or inner ear (tympanoplasty, endolymphatic sac drainage, vestibular schwannoma).
- •Pregnant (contraceptive method, HAS criteria) or nursing mothers
- •Contraindications to performing MRI (pace maker, metallic shards, claustrophobia)
- •Contraindications (relative) to injecting gadolinium (severe renal failure due to the risk of systemic nephrogenic fibrosis, history of allergic reaction)
- •Patient under legal protection
排除标准
- 未提供
研究组 & 干预措施
3D Flair sequence
Optimized 3D FLAIR sequence before and 4 hours after the usual care MRI (with contrast product)
干预措施: 3D Flair sequence (Other)
结局指标
主要结局
Kappa coeficient
时间窗: 1 hour before baseline (usual care MRI)
the non-inferiority of the non-enhanced Flair sequence compared to the reference technique by indirect comparison with the reference method (Kappa coefficient \> or equal to 0.81).
次要结局
- inter-observer correlation(1 hour before baseline, baseline, 4 hours after baseline)