Actively Recruiting
Radiosurgery Effects on Hearing and Nerve Functions in Patients with Vestibular Schwannoma An Observational Study Comparing Radiosurgery and MRI Monitoring
Led by University Hospital, Geneva · Updated on 2025-01-13
258
Participants Needed
1
Research Sites
407 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of stereotactic radiosurgery (SRS) on patients with vestibular Schwannoma, a type of tumor affecting nerves related to hearing and balance. The study compares patients treated with SRS to those managed by regular MRI observation, focusing on how these treatments impact hearing, balance, taste, and facial nerve function. They will also examine if tumor features seen on MRI can predict hearing preservation and vestibular function. Additionally, patients will complete questionnaires to assess their quality of life. The study includes both a retrospective and a prospective part. The retrospective part looks back at patients treated or observed between 2014 and 2021, collecting detailed clinical data, treatment plans, and MRI features from hospital records. The prospective part will gather standardized follow-up data moving forward, with consistent MRI scans and evaluations of hearing, balance, facial nerve function, and quality of life. Treatment decisions are made independently by a multidisciplinary skull base tumor board. Participants will undergo assessments of their hearing and nerve functions, along with questionnaires on quality of life. Researchers will monitor changes in hearing ability and word recognition over one year as primary outcomes. The study also involves detailed analysis of tumor characteristics and treatment parameters to develop models predicting treatment-related ear toxicity. Data collection and evaluations will continue to provide comprehensive information on the effects of radiosurgery compared to conservative management.
CONDITIONS
Official 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 as decided by the skull base tumor board
- Patients willing to participate and provide informed consent
You will not qualify if you...
- Previous surgical or radiation therapy for vestibular Schwannoma, including stereotactic radiosurgery
- Diagnosis of neurofibromatosis type II
- Preexisting severe hearing loss with pure tone average over 90 and word recognition score under 10% at initial assessment
- Previous middle ear surgery on the affected ear
- Concurrent treatment with other experimental drugs
AI-Screening
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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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