Secondary Endolymphatic Hydrops and Vestibular Schwannomas on 3 Tesla MRI
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| ClinicalTrials.gov Identifier: NCT03593577 |
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Recruitment Status : Unknown
Verified June 2018 by University Hospital, Strasbourg, France.
Recruitment status was: Recruiting
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
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Endolymphatic hydrops is well known of the lay public in its primary form that is Ménière disease. Nowadays, the best w ay to approach it in vivo, is to use magnetic resonance imaging (MRI).
However, endolymphatic hydrops don't limit itself to its primary form but cover a whole range of pathologies.
The hypothesis is that patients with vestibular schwannomas are more likely to develop secondary saccular hydrops.
The aim is to compare high-resolution T2-weighted images of the saccule in patients followed up for vestibular schwannomas with healthy volunteers and histological sections from cadavers in order to identify its changes.
The secondary purpose of The protocol is to determine if vestibular and audiometric abnormalities could be related to this secondary hydrops more specifically than to the tumor size and localisation.
| Condition or disease |
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| Vestibular Schwannoma |
| Study Type : | Observational |
| Estimated Enrollment : | 185 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Saccular Dilatation, Endolymphatic Hydrops and Vestibular Schwannoma : is Vertigo Really Correlated to the Tumor ? A Retrospective Study Based on FIESTA-C Sequence Using a 3 Tesla MRI |
| Actual Study Start Date : | June 1, 2018 |
| Estimated Primary Completion Date : | June 2019 |
| Estimated Study Completion Date : | June 2019 |
- Presence or absence of height and width of the saccule on MRI. [ Time Frame: 1 hour after the realization of the MRI ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Age> 18,
- Subject having benefited from an MRI with T2 high-resolution 3D sequence (FIESA) in the context of the diagnosis of vestibular schwannoma between 2008 and 2017 at the University Hospitals of Strasbourg,
- Subject who has agreed to the use of medical data for the purposes of this research.
Exclusion Criteria:
- Refusal of the patient to participate in the study
- Insufficient imaging data,
- Tumors already treated,
- Atypical tumors with uncertain diagnosis, intra-labrinthic or intra-labyrinthine schwannomas, concomitant infectious or inflammatory pathology in the middle or inner ear.
- Impossibility of giving the subject informed information (difficulty understanding the subject,)
- Subject under the protection of justice
- Subject under guardianship or curatorship
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03593577
| Contact: Aïna VENKATASAMY,, MD | 33 3 88 12 78 65 | aina.venkatasamy@chru-strasbourg.fr | |
| Contact: Aurélie KARCH-GEORGES, MD | 33 3 88 12 78 65 | aurelie.karch@chru-strasbourg.fr |
| France | |
| Service Imagerie 1 | Recruiting |
| Strasbourg, France, 67091 | |
| Contact: Aïna VENKATASAMY, MD 33 3 88 12 78 65 aurelie.karch@chru-strasbourg.fr | |
| Contact: Aurélie KARCH-GEORGES, MD 33 3 88 12 78 65 aurelie.karch@chru-strasbourg.fr | |
| Principal Investigator: Aïna VENKATASAMY, MD | |
| Sub-Investigator: Aurélie KARCH-GEORGES, MD | |
| Sub-Investigator: Francis VEILLON, MD, PhD | |
| Responsible Party: | University Hospital, Strasbourg, France |
| ClinicalTrials.gov Identifier: | NCT03593577 |
| Other Study ID Numbers: |
7025 |
| First Posted: | July 20, 2018 Key Record Dates |
| Last Update Posted: | July 20, 2018 |
| Last Verified: | June 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Schwannoma saccular dilatation endolymphatic hydrops magnetic resonnance imaging vertigo |
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Neurilemmoma Neuroma, Acoustic Endolymphatic Hydrops Edema Labyrinth Diseases Ear Diseases Otorhinolaryngologic Diseases Nervous System Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neuroma Nerve Sheath Neoplasms Neoplasms, Nerve Tissue Cranial Nerve Neoplasms Nervous System Neoplasms Neoplasms by Site Peripheral Nervous System Neoplasms Vestibulocochlear Nerve Diseases Retrocochlear Diseases Otorhinolaryngologic Neoplasms Cranial Nerve Diseases |