Actively Recruiting
Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma
Led by University Hospital, Geneva · Updated on 2025-01-13
258
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of stereotactic radiosurgery (SRS) on patients with vestibular Schwannoma, focusing on how this treatment impacts the functions of the cochlear, vestibular, gustatory, and facial nerves. The study also compares these effects with those observed in patients managed conservatively through MRI-based observation. Additionally, the study evaluates how tumor characteristics seen on radiological imaging may predict hearing preservation and vestibular function, while also assessing patients' quality of life through questionnaires. The study includes both retrospective and prospective parts. The retrospective analysis reviews data from patients treated between 2014 and 2021, collecting information on demographics, treatment details, hearing and nerve function, symptoms, tumor features from MRI scans, and radiosurgery parameters. The prospective part will follow patients from now on, using standardized MRI and functional assessments to gather detailed follow-up data. Patients are grouped into those treated with stereotactic radiosurgery and those under conservative MRI-based observation. The multidisciplinary skull base tumor board independently decides treatment for each patient. Participants will undergo evaluations including hearing tests, vestibular and facial nerve function assessments, and quality of life questionnaires at baseline and during follow-up visits. These assessments occur at 1, 3, and 5 years after treatment or observation, measuring changes in hearing ability, nerve function, and patient-reported quality of life. The investigators aim to develop models predicting ototoxicity based on tumor and treatment characteristics. Data collection and monitoring will continue up to five years, with safety and function carefully tracked throughout the study period.
CONDITIONS
Brief Title
Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or above
- Patients with unilateral vestibular Schwannoma treated either with stereotactic radiosurgery or MRI-based observation
- Patients willing to participate and provide informed consent
You will not qualify if you...
- Previous surgery or radiation therapy for vestibular Schwannoma
- Diagnosis of neurofibromatosis type II
- Preexisting profound hearing loss with pure tone average greater than 90 and word recognition score less than 10%
- Previous middle ear surgery on the affected ear
- Concurrent treatment with other experimental drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants with unilateral vestibular Schwannoma are observed either after stereotactic radiosurgery or through MRI-based observation to evaluate tumor morphology, hearing, vestibular and facial nerve function, and quality of life.
Regular visits with MRI and functional assessments at 6 months, 1 year, 3 years, and 5 years
Trial Site Locations
Total: 1 location
1
Service d'ORL et Chirurge cervico-faciale, Hopitaux Universitaires de Genève
Geneva, Switzerland, 1205
Actively Recruiting
Research Team
P
Pascal Senn
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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