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

NCT ID: NCT05987215

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Otosclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CASE

Patients with surgically confirmed otosclerosis who initially consulted for conductive hearing loss with normal otoscopy, and with a high resolution computed tomography of temporal bone available

Radiologic diagnosis

Intervention Type COMBINATION_PRODUCT

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

Artificial intelligence diagnosis

Intervention Type DIAGNOSTIC_TEST

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

CONTROL

Random patients with a high resolution computed tomography scan of temporal bone performed without suspicion of otosclerosis and considered normal

Radiologic diagnosis

Intervention Type COMBINATION_PRODUCT

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

Artificial intelligence diagnosis

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Radiologic diagnosis

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

Intervention Type COMBINATION_PRODUCT

Artificial intelligence diagnosis

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maxime FIEUX, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospices Civils de Lyon, Centre Hospitalier Lyon sud, Service d'ORL, d'otoneurchirurgie et de chirurgie cervico-facaile

Pierre-Bénite, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

22-5019 / 69HCL22_1193

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cranial Nerves Tractography
NCT02978911 RECRUITING NA