Vestibular SchwannomaNCT05641441
Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma
An observational study of Vestibular Schwannoma and Ototoxicity, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The investigators aim to study the impact of stereotactic radiosurgery, for the treatment of vestibular Schwannoma, on the cochlear, vestibular, gustatory, and facial nerve functions and compare it with a conservatively treated group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vestibular Schwannoma, Ototoxicity
- What is being tested?
- Stereotactic radiosurgery
- Type of treatment
- Surgery or procedure
- How many people
- 258 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Jan 2023to 15 Nov 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted at the Geneva University Hospitals (tertiary care facility) in Switzerland. For the retrospective part of our research project, the investigators aim to analyze non-genetic health-related personal data in a coded form from approximately 150 patients treated between 2014 and 2021. Regarding the prospective study part, patient recruitment will be done through the multidisciplinary skull base tumor board, where cases are discussed in detail, treatment decisions are made consensually based on the contribution of different specialists and in agreement with the current international recommendations. Patients eligible for study inclusion will be contacted to obtain informed consent. The investigators aim to include 108 participants.
Who may be able to join
- Aged 18 years or above
- Patients with unilateral VS treated either with SRS or MRI-based observation strategy, as proposed by the institution's skull base tumor board independently of the study
- Patients willing to take part in the study and give their informed consent
Who cannot join
- Previous surgical or radiation therapy for VS (including SRS)
- Patients diagnosed with neurofibromatosis type II
- Preexisting profound hearing loss, with a pure tone average (PTA) >90 and word recognition score (WRS) <10%, upon initial assessment
- Previous middle ear surgery of the affected ear
- Concurrent treatment with other experimental drugs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Service d'ORL et Chirurge cervico-faciale, Hopitaux Universitaires de Genève
Geneva, 1205
Pascal Senn, 0223728244, pascal.senn@hcuge.ch
About this study
The investigators aim to study the impact of stereotactic radiosurgery, for the treatment of vestibular Schwannoma, on the cochlear, vestibular, gustatory, and facial nerve functions and compare it with a conservatively treated group. The predictive value of radiological tumor characteristics on hearing preservation and vestibular function will be also evaluated.
Additionally, the investigators will invite patients with vestibular Schwannoma to fill out questionnaires to assess their quality of life.
Read the detailed description
The study will have a retrospective part and a prospective part. The retrospective study will be based on a series of consecutive patients with vestibular Schwannoma (VS) treated either with stereotactic radiosurgery (SRS) or followed up radiologically between 2014 and 2021 in our institution. The following data will be retrieved from the hospital archiving system and will be subsequently analyzed: demographics, patient characteristics, details regarding SRS planning, clinical baseline and follow-up data, hearing, vestibular and taste function assessment initially and during follow-up, presence of additional symptoms (tinnitus, hemifacial spasm, trigeminal neuralgia), radiosurgery parameters and MRI characteristics of tumors. The following parameters will be retrospectively measured on MRI images by an experienced radiologist in each VS: tumor volume, ratio of brain stem compression, tumor shape and distance to the fundus of the internal auditory canal, length of the tumor in the internal auditory canal, and signal intensity in the cochlea and vestibule. The MRI textural features extracted from whole tumor segmentation of VSs will be calculated and analyzed with MatLab®. They include shape features, first order and second order textural features.
The prospective study part aims to obtain more precise and predefined follow-up data from patients treated either with SRS or followed up conservatively from now on. Our institution's multidisciplinary skull base tumor board will be responsible for treatment decisions independently of the study. It will be a single-center observational cohort study investigating the respective impact of tumor morphology and SRS on the inner ear, the facial nerve function, and the quality of life of these patients. As data collection will be done prospectively, MRI acquisition parameters will be standardized, as well as quantification of hearing, vestibular, facial nerve function, and quality of life. Additionally, the investigators will analyze the characteristics of the tumors and several parameters of the irradiation protocol to develop predictive models for ototoxicity.
- Conditions
- Vestibular Schwannoma, Ototoxicity
- Being tested
- Stereotactic radiosurgery
- Keywords
- Radiosurgery, Ototoxicity, Vestibular Schwannoma, Hearing loss, Quality of Life
- Medical subject headings
- Neuroma, Acoustic, Ototoxicity, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic radiosurgeryRadiation
Stereotactic radiosurgery
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic radiosurgery group | Patients with unilateral Vestibular Schwannoma treated with stereotactic radiosurgery, as proposed by the institution's skull base tumor board independently of the study. Receives: Radiation: Stereotactic radiosurgery | |
| Wait and scan group | Patients with unilateral Vestibular Schwannoma followed with an MRI-based observation strategy, as proposed by the institution's skull base tumor board independently of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pure Tone Average from baseline
Hearing status as measured by audiometric tonal testing and calculated from the average of 500 Hz, 1000 Hz, 2000 Hz and 3000 Hz.
Measured: 1-year
Change of Word recognition score from baseline
Hearing status as measured by audiometric vocal testing and calculated as the percentage of correctly identified monosyllabic words presented at the speech recognition threshold + 40 decibel hearing level
Measured: 1-year
Secondary outcomes (13)
Change of Pure Tone Average from baseline
Hearing status as measured by audiometric tonal testing and calculated from the average of 500 Hz, 1000 Hz, 2000 Hz and 3000 Hz.
Measured: 3 and 5-year
Change of High-frequency Pure Tone Average from baseline
Hearing status as measured by audiometric tonal testing and calculated from the average of 3000 Hz, 4000 Hz and 6000 Hz.
Measured: 1, 3 and 5-year
Change of Word recognition score from baseline
Hearing status as measured by audiometric vocal testing and calculated as the percentage of correctly identified monosyllabic words presented at the speech recognition threshold + 40 decibel hearing level
Measured: 3 and 5-year
Change of video-oculography from the baseline
Video-oculography assessment to detect a pathologic nystagmus or a pathologic smooth pursuit
Measured: 1, 3 and 5-year
Change of caloric ipsilateral testing (degree of asymmetry) from baseline
Caloric testing to assess the vestibulo-ocular reflex in the low-frequency range.
Measured: 1, 3 and 5-year
Change of the cervical Vestibular Evoked Myogenic Potential (cVEMP) from baseline
Assessment of a present or absent reflex which reflects the function of saccule
Measured: 1, 3 and 5-year
Change of the ocular Vestibular Evoked Myogenic Potential (oVEMP) from baseline
Assessment of a present or absent reflex which reflects the function of utricle
Measured: 1, 3 and 5-year
Change of the Video Head Impulse Test (VHIT) from baseline
Assessment of the VHIT to detect dysfunction of the vestibulo-ocular reflex in the high-frequency range.
Measured: 1, 3 and 5-year
Change of facial nerve function from baseline
House-Brackmann scale score ranges from 1 (best) to 6 (worst)
Measured: 1, 3 and 5-year
Change of taste function from baseline
"Taste strips" test score ranges from 0 (worst) to 16 (best) on each side of the tongue
Measured: 6 and 12-month
Change of 36-Item Short Form Health Survey (SF-36) score from baseline
SF-36 score ranges from 0 (worst) to 100 (best)
Measured: 1, 3 and 5-year
Change of Penn Acoustic Neuroma Quality-of-Life (PANQOL) scale score from baseline
Penn Acoustic Neuroma Quality-of-Life (PANQOL) scale score ranges from 0 (worst) to 100 (best)
Measured: 1, 3 and 5-year
Change of Tinnitus Handicap Inventory (THI) score from baseline
Tinnitus Handicap Inventory (THI) score ranges from 0 (best) to 100 (worst)
Measured: 1, 3 and 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start24 Jan 2023
- Primary completion15 Nov 2030 (estimated)
- Study completion15 Nov 2030 (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, GenevaThe 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
- Other
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pascal Senn, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641441
- Sponsor's protocol ID
- 2022-01257
- Status last verified
- Jan 2025
- First submitted
- 16 Nov 2022
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma
- ClinicalTrials.gov ID
- NCT05641441
- Acronym / sponsor ID
- 2022-01257
- Conditions
- Vestibular Schwannoma, Ototoxicity
- Keywords
- Radiosurgery, Ototoxicity, Vestibular Schwannoma, Hearing loss, Quality of Life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 15 Nov 2030 (estimated)
- Study completion
- 15 Nov 2030 (estimated)
- First posted
- 7 Dec 2022 (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.
The investigators aim to study the impact of stereotactic radiosurgery, for the treatment of vestibular Schwannoma, on the cochlear, vestibular, gustatory, and facial nerve functions and compare it with a conservatively treated group. The predictive value of radiological tumor characteristics on hearing preservation and vestibular function will be also evaluated.
Additionally, the investigators will invite patients with vestibular Schwannoma to fill out questionnaires to assess their quality of life.
Detailed description
The study will have a retrospective part and a prospective part. The retrospective study will be based on a series of consecutive patients with vestibular Schwannoma (VS) treated either with stereotactic radiosurgery (SRS) or followed up radiologically between 2014 and 2021 in our institution. The following data will be retrieved from the hospital archiving system and will be subsequently analyzed: demographics, patient characteristics, details regarding SRS planning, clinical baseline and follow-up data, hearing, vestibular and taste function assessment initially and during follow-up, presence of additional symptoms (tinnitus, hemifacial spasm, trigeminal neuralgia), radiosurgery parameters and MRI characteristics of tumors. The following parameters will be retrospectively measured on MRI images by an experienced radiologist in each VS: tumor volume, ratio of brain stem compression, tumor shape and distance to the fundus of the internal auditory canal, length of the tumor in the internal auditory canal, and signal intensity in the cochlea and vestibule. The MRI textural features extracted from whole tumor segmentation of VSs will be calculated and analyzed with MatLab®. They include shape features, first order and second order textural features.
The prospective study part aims to obtain more precise and predefined follow-up data from patients treated either with SRS or followed up conservatively from now on. Our institution's multidisciplinary skull base tumor board will be responsible for treatment decisions independently of the study. It will be a single-center observational cohort study investigating the respective impact of tumor morphology and SRS on the inner ear, the facial nerve function, and the quality of life of these patients. As data collection will be done prospectively, MRI acquisition parameters will be standardized, as well as quantification of hearing, vestibular, facial nerve function, and quality of life. Additionally, the investigators will analyze the characteristics of the tumors and several parameters of the irradiation protocol to develop predictive models for ototoxicity.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stereotactic radiosurgery group | – | Radiation: Stereotactic radiosurgeryPatients with unilateral Vestibular Schwannoma treated with stereotactic radiosurgery, as proposed by the institution's skull base tumor board independently of the study. |
| Wait and scan group | – | –Patients with unilateral Vestibular Schwannoma followed with an MRI-based observation strategy, as proposed by the institution's skull base tumor board independently of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted at the Geneva University Hospitals (tertiary care facility) in Switzerland. For the retrospective part of our research project, the investigators aim to analyze non-genetic health-related personal data in a coded form from approximately 150 patients treated between 2014 and 2021. Regarding the prospective study part, patient recruitment will be done through the multidisciplinary skull base tumor board, where cases are discussed in detail, treatment decisions are made consensually based on the contribution of different specialists and in agreement with the current international recommendations. Patients eligible for study inclusion will be contacted to obtain informed consent. The investigators aim to include 108 participants.
Key inclusion criteria (3 listed)
- Aged 18 years or above
- Patients with unilateral VS treated either with SRS or MRI-based observation strategy, as proposed by the institution's skull base tumor board independently of the study
- Patients willing to take part in the study and give their informed consent
Key exclusion criteria (5 listed)
- Previous surgical or radiation therapy for VS (including SRS)
- Patients diagnosed with neurofibromatosis type II
- Preexisting profound hearing loss, with a pure tone average (PTA) >90 and word recognition score (WRS) <10%, upon initial assessment
- Previous middle ear surgery of the affected ear
- Concurrent treatment with other experimental drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic radiosurgeryStereotactic radiosurgery | Radiation | Stereotactic radiosurgery group |
Primary outcome
Change of Pure Tone Average from baseline
Time frame: 1-year
Hearing status as measured by audiometric tonal testing and calculated from the average of 500 Hz, 1000 Hz, 2000 Hz and 3000 Hz.
Change of Word recognition score from baseline
Time frame: 1-year
Hearing status as measured by audiometric vocal testing and calculated as the percentage of correctly identified monosyllabic words presented at the speech recognition threshold + 40 decibel hearing level
13 secondary outcomes
Change of Pure Tone Average from baseline
Time frame: 3 and 5-year
Change of High-frequency Pure Tone Average from baseline
Time frame: 1, 3 and 5-year
Change of Word recognition score from baseline
Time frame: 3 and 5-year
Change of video-oculography from the baseline
Time frame: 1, 3 and 5-year
Change of caloric ipsilateral testing (degree of asymmetry) from baseline
Time frame: 1, 3 and 5-year
Change of the cervical Vestibular Evoked Myogenic Potential (cVEMP) from baseline
Time frame: 1, 3 and 5-year
Change of the ocular Vestibular Evoked Myogenic Potential (oVEMP) from baseline
Time frame: 1, 3 and 5-year
Change of the Video Head Impulse Test (VHIT) from baseline
Time frame: 1, 3 and 5-year
Change of facial nerve function from baseline
Time frame: 1, 3 and 5-year
Change of taste function from baseline
Time frame: 6 and 12-month
Change of 36-Item Short Form Health Survey (SF-36) score from baseline
Time frame: 1, 3 and 5-year
Change of Penn Acoustic Neuroma Quality-of-Life (PANQOL) scale score from baseline
Time frame: 1, 3 and 5-year
Change of Tinnitus Handicap Inventory (THI) score from baseline
Time frame: 1, 3 and 5-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
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 and Ototoxicity, run by University Hospital, Geneva at 1 site in Switzerland.
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 5 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: looking for participants now, as of the sponsor's last update on 13 Jan 2025. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pascal Senn (0223728244, pascal.senn@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Pure Tone Average from baseline (time frame: 1-year). The study lists 2 primary outcomes in all. 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 13 Jan 2025.