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NCT Number: NCT05641441

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stereotactic Radiosurgery

Radiation

Stereotactic radiosurgery

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Change of Pure Tone Average from baseline

    Time frame: 3 and 5-year

    Hearing status as measured by audiometric tonal testing and calculated from the average of 500 Hz, 1000 Hz, 2000 Hz and 3000 Hz.

  2. Change of High-frequency Pure Tone Average from baseline

    Time frame: 1, 3 and 5-year

    Hearing status as measured by audiometric tonal testing and calculated from the average of 3000 Hz, 4000 Hz and 6000 Hz.

  3. Change of Word recognition score from baseline

    Time frame: 3 and 5-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

  4. Change of video-oculography from the baseline

    Time frame: 1, 3 and 5-year

    Video-oculography assessment to detect a pathologic nystagmus or a pathologic smooth pursuit

  5. Change of caloric ipsilateral testing (degree of asymmetry) from baseline

    Time frame: 1, 3 and 5-year

    Caloric testing to assess the vestibulo-ocular reflex in the low-frequency range.

  6. Change of the cervical Vestibular Evoked Myogenic Potential (cVEMP) from baseline

    Time frame: 1, 3 and 5-year

    Assessment of a present or absent reflex which reflects the function of saccule

  7. Change of the ocular Vestibular Evoked Myogenic Potential (oVEMP) from baseline

    Time frame: 1, 3 and 5-year

    Assessment of a present or absent reflex which reflects the function of utricle

  8. Change of the Video Head Impulse Test (VHIT) from baseline

    Time frame: 1, 3 and 5-year

    Assessment of the VHIT to detect dysfunction of the vestibulo-ocular reflex in the high-frequency range.

  9. Change of facial nerve function from baseline

    Time frame: 1, 3 and 5-year

    House-Brackmann scale score ranges from 1 (best) to 6 (worst)

  10. Change of taste function from baseline

    Time frame: 6 and 12-month

    "Taste strips" test score ranges from 0 (worst) to 16 (best) on each side of the tongue

  11. Change of 36-Item Short Form Health Survey (SF-36) score from baseline

    Time frame: 1, 3 and 5-year

    SF-36 score ranges from 0 (worst) to 100 (best)

  12. Change of Penn Acoustic Neuroma Quality-of-Life (PANQOL) scale score from baseline

    Time frame: 1, 3 and 5-year

    Penn Acoustic Neuroma Quality-of-Life (PANQOL) scale score ranges from 0 (worst) to 100 (best)

  13. Change of Tinnitus Handicap Inventory (THI) score from baseline

    Time frame: 1, 3 and 5-year

    Tinnitus Handicap Inventory (THI) score ranges from 0 (best) to 100 (worst)

Study contacts

Contact information is provided by the study sponsor or research team.

Pascal Senn

CONTACT

[email protected]

0223728244

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Dec 7, 2022
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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