跳至主要内容
临床试验/NCT05214053
NCT05214053终止不适用

Cone Beam vs MDCT for Diagnosis and Pre-operative Evaluation of Otosclerosis

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2022年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
1
试验地点
1
主要终点
False negative rate of Cone Beam for the diagnosis of otosclerosis

研究概览

简要总结

This study aims to compare the Cone Beam and the multi-detector computed tomography for diagnosis and pre-operative evaluation of otosclerosis in patients addressed for conductive hearing loss with intact tympanic membrane. The study aims to show that the Cone Beam offers equivalent performances with lower radiation dosage in this indication

详细描述

Otosclerosis is an inflammatory bone remodeling disorder of the otic capsule, characterized by spongiotic new bone formation, causing stamped ankylosis that can result in conductive hearing loss. Until now, the gold standard imaging technique for diagnosis and pre-operative evaluation of otosclerosis has been multi-detector computed tomography (MDCT). Cone Beam computed tomography is a relatively recent imaging modality. It is associated with a lower radiation dosage compared to MDCT, and a high spatial resolution that allows a more precise analysis of bone structures. During the last 15 years, its use has been increasingly common in odontology and craniofacial surgery. Several studies have already studied the utility of Cone Beam for temporal bone pathologies, including recent retrospective studies that showed satisfying diagnostic performances for otosclerosis. Up to now, very few prospective studies have compared those two imaging modalities for otosclerosis diagnosis and pre-operative evaluation.

Therefore, those two exams will be performed in patients addressed to the hospital for conductive hearing loss with intact tympanic membrane. Thus, the performance of Cone Beam will be compared to MDCT, regarding the positive diagnosis of otosclerosis, the analysis of anatomical structures of the temporal bone for pre-operative evaluation, and also the benefits in terms of irradiation. The MDCTs will include fewer slices than routine MDCTs and will be centered on the area of interest, in order to keep a total radiation dosage smaller or equivalent to routine care

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

入选标准

  • Adult patients (18 years and older)
  • Requiring radiological assessment for conductive hearing loss with intact tympanic membrane, confirmed by otoscopy and audiogram
  • Signed informed consent
  • Affiliated or beneficiary of health insurance

排除标准

  • Absence of otosclerosis on the MDCT
  • History of middle ear surgery
  • Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control
  • Patient under legal protection

结局指标

主要结局

False negative rate of Cone Beam for the diagnosis of otosclerosis

时间窗: 1 day

False negative rate of Cone Beam for the diagnosis of otosclerosis, compared to MDCT (gold standard).

次要结局

  • radiologic grades of otosclerosis(1 day)
  • extension to round window(1 day)
  • radiation dosage(1 day)
  • Existence of a bone canal around the labyrinthine portion of the facial nerve(1 day)

研究者

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

研究点 (1)

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