Clinical trial NCT05641441: Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma
Official title: Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vestibular Schwannoma
Ototoxicity
Keywords: Radiosurgery
Ototoxicity
Vestibular Schwannoma
Hearing loss
Quality of Life
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Pure Tone Average from baseline
timeFrame: 1-year
measure: Change of Word recognition score from baseline
timeFrame: 1-year
Secondary outcomes:
measure: Change of Pure Tone Average from baseline
timeFrame: 3 and 5-year
measure: Change of High-frequency Pure Tone Average from baseline
timeFrame: 1, 3 and 5-year
measure: Change of Word recognition score from baseline
timeFrame: 3 and 5-year
measure: Change of video-oculography from the baseline
timeFrame: 1, 3 and 5-year
measure: Change of caloric ipsilateral testing (degree of asymmetry) from baseline
timeFrame: 1, 3 and 5-year
measure: Change of the cervical Vestibular Evoked Myogenic Potential (cVEMP) from baseline
timeFrame: 1, 3 and 5-year
measure: Change of the ocular Vestibular Evoked Myogenic Potential (oVEMP) from baseline
timeFrame: 1, 3 and 5-year
measure: Change of the Video Head Impulse Test (VHIT) from baseline
timeFrame: 1, 3 and 5-year
measure: Change of facial nerve function from baseline
timeFrame: 1, 3 and 5-year
measure: Change of taste function from baseline
timeFrame: 6 and 12-month
measure: Change of 36-Item Short Form Health Survey (SF-36) score from baseline
timeFrame: 1, 3 and 5-year
measure: Change of Penn Acoustic Neuroma Quality-of-Life (PANQOL) scale score from baseline
timeFrame: 1, 3 and 5-year
measure: Change of Tinnitus Handicap Inventory (THI) score from baseline
timeFrame: 1, 3 and 5-year
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Service d'ORL et Chirurge cervico-faciale, Hopitaux Universitaires de Genève
Study officials:
References: