Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma

Vestibular Schwannoma Clinical Trial

Official title:

Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05641441
• Other study ID #: 2022-01257
• Status: Recruiting
• Start date: January 24, 2023
• Est. completion date: November 15, 2030

Study information

• Verified date: July 2023
• Source: University Hospital, Geneva
• Contact: Pascal Senn
• Phone: 0223728244
• Email: pascal.senn[@]hcuge.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 258
• Est. completion date: November 15, 2030
• Est. primary completion date: November 15, 2030
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurilemmoma
• Neuroma, Acoustic
• Ototoxicity
• Vestibular Schwannoma

Intervention

Radiation:
• Stereotactic radiosurgery
Stereotactic radiosurgery

Locations

Country	Name	City	State
Switzerland	Service d'ORL et Chirurge cervico-faciale, Hopitaux Universitaires de Genève	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change of facial nerve function from baseline	House-Brackmann scale score ranges from 1 (best) to 6 (worst)	1, 3 and 5-year
Secondary	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
Secondary	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
Secondary	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
Secondary	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