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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05987215
Acronym
OtoIA
Enrollment
240
Registered
2023-08-14
Start date
2022-07-01
Completion date
2023-10-01
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otosclerosis

Keywords

otosclerosis, IA, deep learning, temporal bone CT

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.

Interventions

COMBINATION_PRODUCTRadiologic diagnosis

Each CT scan is interpreted by a radiologist and is assigned as positive or negative for the diagnosis of otosclerosis

Each CT scan is screened by the deep learning algorithm and is assigned as positive or negative for the diagnosis of otosclerosis

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
Yes

Inclusion criteria

* Inclusion Criteria \* : * age over 18 * high resolution temporal bone CT scan available for analysis * for the case group : surgical confirmation of positive diagnosis for otosclerosis * for the control group : a first radiological analysis in favor of a normal temporal bone CT scanner and an initial radiologic report considered normal as well *

Exclusion criteria

\* : * age under 18 * no high resolution temporal bone CT scan available for analysis * unwillingness to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
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 curvethrough study completion, an average of 5 monthsThese 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026