跳至主要内容
临床试验/NCT05987215
NCT05987215进行中(未招募)不适用

Interest of Using Deep Learning Algorithm for Otosclerosis Detection on Temporal Bone High Resolution CT

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
240
试验地点
1
主要终点
Diagnostic performance of the artificial intelligence algorithm compared to the diagnostic performance of the radiologist : sensitivity, specificity, positive and negative predictive value, area under the ROC curve

研究概览

简要总结

Otosclerosis is a relatively frequent pathology, of multifactorial origin with genetic and hormonal part, predominantly in women. This disease causes a disorder of the bone metabolism of the middle and inner ear, responsible for a progressive deafness, which can become severe.

Several elements are necessary to make the diagnosis of otosclerosis: the clinical examination and questioning, the audiometric assessment, and finally the temporal bone CT.

The CT scan allows to detect foci of otosclerosis within the bone of the middle or inner ear. This diagnosis is sometimes difficult and requires interpretation by a trained radiologist.

The investigators would like to evaluate the ability of a deep learning algorithm to detect these foci of otosclerosis, and to compare its diagnostic performance with a trained radiologist.

详细描述

Otosclerosis is a relatively frequent pathology, of multifactorial origin with genetic and hormonal part, predominantly in women. This disease causes a disorder of the bone metabolism of the middle and inner ear, responsible for a progressive deafness, which can become severe.

Several elements are necessary to make the diagnosis of otosclerosis: the clinical examination and questioning, the audiometric assessment, and finally the temporal bone CT.

The CT scan allows to detect foci of otosclerosis within the bone of the middle or inner ear. This diagnosis is sometimes difficult and requires interpretation by a trained radiologist.

The investigators would like to evaluate the ability of a deep learning algorithm to detect these foci of otosclerosis, and to compare its diagnostic performance with a trained radiologist.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Diagnostic performance of the artificial intelligence algorithm compared to the diagnostic performance of the radiologist : sensitivity, specificity, positive and negative predictive value, area under the ROC curve

时间窗: through study completion, an average of 5 months

These diagnostic performances will be established from the positive or negative diagnoses of the algorithm and the radiologist, compared to the "case" or "control" status of each patient included in the study

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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