Service d'ORL et Chirurge cervico-faciale, Hopitaux Universitaires de Genève
Geneva, 1205, Switzerland
Location status: Recruiting
NCT Number: NCT05641441
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Geneva, 1205, Switzerland
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Stereotactic radiosurgery
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.
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
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.
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.
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
Time frame: 1, 3 and 5-year
Video-oculography assessment to detect a pathologic nystagmus or a pathologic smooth pursuit
Time frame: 1, 3 and 5-year
Caloric testing to assess the vestibulo-ocular reflex in the low-frequency range.
Time frame: 1, 3 and 5-year
Assessment of a present or absent reflex which reflects the function of saccule
Time frame: 1, 3 and 5-year
Assessment of a present or absent reflex which reflects the function of utricle
Time frame: 1, 3 and 5-year
Assessment of the VHIT to detect dysfunction of the vestibulo-ocular reflex in the high-frequency range.
Time frame: 1, 3 and 5-year
House-Brackmann scale score ranges from 1 (best) to 6 (worst)
Time frame: 6 and 12-month
"Taste strips" test score ranges from 0 (worst) to 16 (best) on each side of the tongue
Time frame: 1, 3 and 5-year
SF-36 score ranges from 0 (worst) to 100 (best)
Time frame: 1, 3 and 5-year
Penn Acoustic Neuroma Quality-of-Life (PANQOL) scale score ranges from 0 (worst) to 100 (best)
Time frame: 1, 3 and 5-year
Tinnitus Handicap Inventory (THI) score ranges from 0 (best) to 100 (worst)
Contact information is provided by the study sponsor or research team.
University Hospital, Geneva
Other
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.
Published trials that share one or more normalized conditions with this study.
NCT06517888
Cranial Nerve Diseases, Cranial Nerve Neoplasms
Baltimore, Maryland, United States
View Trial DetailsNCT03745534
Cranial Nerve Diseases, Cranial Nerve Neoplasms
Vienna, State of Vienna, Austria
View Trial DetailsNCT03745560
Cranial Nerve Diseases, Cranial Nerve Neoplasms
Vienna, Austria
View Trial DetailsNCT07503613
Cranial Nerve Diseases, Cranial Nerve Neoplasms
Dallas, Texas, United States
View Trial Details