UnknownNot Applicable

KNOW HOW TO POSITION THE SACCULE AND UTRICULE IN SCANNING

France40 participantsStarted 2021-12-13

Plain-language 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.

Who can participate

Age range

6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: up to 10 month

Trial details

NCT IDNCT06179251

SponsorUniversity Hospital, Strasbourg, France

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12

Contact for this trial

francis VEILLON, MD, PhD

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

View on ClinicalTrials.gov More Otosclerosis trials