Actively Recruiting

Age: 18Years +
All Genders
ID05641441

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

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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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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