Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma

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.

Study Overview

• Status: Recruiting
• Conditions: Ototoxicity; Vestibular Schwannoma
• Intervention / Treatment: Radiation: Stereotactic radiosurgery

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 Type: Observational
• Enrollment (Estimated): 258

Contacts and Locations

• Study Contact: Name: Pascal Senn; Phone Number: 0223728244; Email: pascal.senn@hcuge.ch

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • Recruiting
    • Service d'ORL et Chirurge cervico-faciale, Hopitaux Universitaires de Genève
    • Contact: Pascal Senn; Phone Number: 0223728244; Email: pascal.senn@hcuge.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Radiation: Stereotactic radiosurgery; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	1-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1, 3 and 5-year
Change of video-oculography from the baseline	Video-oculography assessment to detect a pathologic nystagmus or a pathologic smooth pursuit	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.	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	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	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.	1, 3 and 5-year
Change of facial nerve function from baseline	House-Brackmann scale score ranges from 1 (best) to 6 (worst)	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	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)	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)	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)	1, 3 and 5-year
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.	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	3 and 5-year

Collaborators and Investigators

• Sponsor: University Hospital, Geneva

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2023
• Primary Completion (Estimated): November 15, 2030
• Study Completion (Estimated): November 15, 2030

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Quality of Life; Hearing loss; Ototoxicity; Radiosurgery; Vestibular Schwannoma
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Chemically-Induced Disorders; Otorhinolaryngologic Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Nerve Sheath Neoplasms; Peripheral Nervous System Neoplasms; Neuroendocrine Tumors; Ear Diseases; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Neuroma; Cranial Nerve Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ototoxicity; Neurilemmoma; Neuroma, Acoustic
• Other Study ID Numbers: 2022-01257

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No