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Clinical Trials/NCT05987215
NCT05987215
Active, not recruiting
Not Applicable

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

Hospices Civils de Lyon1 site in 1 country240 target enrollmentJuly 1, 2022
ConditionsOtosclerosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Otosclerosis
Sponsor
Hospices Civils de Lyon
Enrollment
240
Locations
1
Primary Endpoint
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
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
October 1, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 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

Study Sites (1)

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