Vestibular SchwannomaNCT03593577
Secondary Endolymphatic Hydrops and Vestibular Schwannomas on 3 Tesla MRI
An observational study of Vestibular Schwannoma, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vestibular Schwannoma
- How many people
- 185 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2018to Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patient 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,
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service Imagerie 1
Strasbourg, 67091
Aïna VENKATASAMY, MD, 33 3 88 12 78 65, aurelie.karch@chru-strasbourg.fr
Aurélie KARCH-GEORGES, MD, 33 3 88 12 78 65, aurelie.karch@chru-strasbourg.fr
About this study
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
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.
Read more
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.
- Conditions
- Vestibular Schwannoma
- Keywords
- Schwannoma, saccular dilatation, endolymphatic hydrops, magnetic resonnance imaging, vertigo
- Medical subject headings
- Neuroma, Acoustic, Neurilemmoma, Endolymphatic Hydrops, Vertigo
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of height and width of the saccule on MRI.
Measured: 1 hour after the realization of the MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start1 Jun 2018
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular SchwannomaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593577
- Sponsor's protocol ID
- 7025
- Status last verified
- Jun 2018
- First submitted
- 22 Jun 2018
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03593577
- Acronym / sponsor ID
- 7025
- Conditions
- Vestibular Schwannoma
- Keywords
- Schwannoma, saccular dilatation, endolymphatic hydrops, magnetic resonnance imaging, vertigo
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient 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,
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence or absence of height and width of the saccule on MRI.
Time frame: 1 hour after the realization of the MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vestibular Schwannoma, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aïna VENKATASAMY,, MD (33 3 88 12 78 65, aina.venkatasamy@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of height and width of the saccule on MRI. (time frame: 1 hour after the realization of the MRI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.