KNOW HOW TO POSITION THE SACCULE AND UTRICULE IN SCANNING

NCT06179251 | Unknown

• 1 other identifier: 8488
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Titanium pistons cause MRI artifacts that prevent interpretation of the vestibule. This disadvantage is not present on CT but the vestibule is not visible. Hence the interest in creating a model with 6 reference cuts in order to position the utricle and the saccule in the vestibule in CT. Furthermore, the scanner has fewer contraindications, greater availability and a shorter examination time than MRI.

Conditions

Otosclerosis

Keywords

Otosclerosis; Vestibular dysfunction; Membranous Labyrinth

Outcome Measures

Primary Outcomes (1)

• Presence or absence of the anatomical structure referenced in the investigators' reading grid on each of the 6 predefined MRI or CT sections

  up to 10 month

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (≥18 years old) and minors (≥ 6 years old) having received an MRI of the internal ear canals from the HUS between 01/01/2018 and 01/01/2021 or a CT scan of the rocks between 07/01/2015 and 01/01/2021

You may qualify if:

• Adults (≥18 years old) and minors (≥ 6 years old)
• Subject having received an MRI of the internal ear canals from the HUS between 01/01/2018 and 01/01/2021 or a CT scan of the rocks between 07/01/2015 and 01/01/2021
• Normal MRI or CT on the side opposite the pathology.
• Normal tonal audiogram on the side opposite the pathology (peripheral facial paralysis assumed to be cold for MRI and petrous fracture for CT).
• Subject who has not expressed his opposition, after information, to the reuse of his data for the purposes of this research.
• Holders of authority who have not expressed their opposition, after information, to the reuse of their child's data for the purposes of this research

You may not qualify if:

• Subject having expressed opposition to participating in the study
• Holders of parental authority who have expressed their opposition to the reuse of their child's data for the purposes of this research
• Imaging with artifacts
• Absence of pure-tone audiogram or its abnormality on the side of the ear studied
• Any malformation or pathology of the vestibule on imaging on the side of the ear studied
• Subjects under guardianship or curatorship

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Radiologie - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Otosclerosis

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

francis VEILLON, MD, PhD

CONTACT

33 3 88 12 78 65; francis.veillon@chru-strasbourg.fr

Floriane LE NORMAND, MD

CONTACT

33 3 88 12 78 65; floriane.le-normand@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 21, 2023
• Study Start: December 13, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 31, 2023
• Last Updated: December 21, 2023

Record last verified: 2023-12

Locations

FR (1)