跳至主要内容
临床试验/NCT03593577
NCT03593577Unknown不适用

Saccular Dilatation, Endolymphatic Hydrops and Vestibular Schwannoma : is Vertigo Really Correlated to the Tumor ? A Retrospective Study Based on FIESTA-C Sequence Using a 3 Tesla MRI

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
185
试验地点
1
主要终点
Presence or absence of height and width of the saccule on MRI.

研究概览

简要总结

Endolymphatic hydrops is well known of the lay public in its primary form that is Ménière disease. Nowadays, the best w ay to approach it in vivo, is to use magnetic resonance imaging (MRI).

However, endolymphatic hydrops don't limit itself to its primary form but cover a whole range of pathologies.

The hypothesis is that patients with vestibular schwannomas are more likely to develop secondary saccular hydrops.

The aim is to compare high-resolution T2-weighted images of the saccule in patients followed up for vestibular schwannomas with healthy volunteers and histological sections from cadavers in order to identify its changes.

The secondary purpose of The protocol is to determine if vestibular and audiometric abnormalities could be related to this secondary hydrops more specifically than to the tumor size and localisation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age> 18,
  • Subject having benefited from an MRI with T2 high-resolution 3D sequence (FIESA) in the context of the diagnosis of vestibular schwannoma between 2008 and 2017 at the University Hospitals of Strasbourg,
  • Subject who has agreed to the use of medical data for the purposes of this research.

排除标准

  • Refusal of the patient to participate in the study
  • Insufficient imaging data,
  • Tumors already treated,
  • Atypical tumors with uncertain diagnosis, intra-labrinthic or intra-labyrinthine schwannomas, concomitant infectious or inflammatory pathology in the middle or inner ear.
  • Impossibility of giving the subject informed information (difficulty understanding the subject,)
  • Subject under the protection of justice
  • Subject under guardianship or curatorship

结局指标

主要结局

Presence or absence of height and width of the saccule on MRI.

时间窗: 1 hour after the realization of the MRI

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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