Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Stereotactic radiosurgery.
- Кому может быть актуально
- Состояния в реестре: Vestibular Schwannoma, Ototoxicity. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швейцария
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Лучевая терапия Stereotactic radiosurgery
Stereotactic radiosurgery
Первичные конечные точки
- Change of Pure Tone Average from baseline [Срок оценки: 1-year]
- Change of Word recognition score from baseline [Срок оценки: 1-year]
Вторичные конечные точки (12)
- Change of Pure Tone Average from baseline [Срок оценки: 3 and 5-year]
- Change of High-frequency Pure Tone Average from baseline [Срок оценки: 1, 3 and 5-year]
- Change of Word recognition score from baseline [Срок оценки: 3 and 5-year]
- Change of video-oculography from the baseline [Срок оценки: 1, 3 and 5-year]
- Change of caloric ipsilateral testing (degree of asymmetry) from baseline [Срок оценки: 1, 3 and 5-year]
- Change of the cervical Vestibular Evoked Myogenic Potential (cVEMP) from baseline [Срок оценки: 1, 3 and 5-year]
- Change of the ocular Vestibular Evoked Myogenic Potential (oVEMP) from baseline [Срок оценки: 1, 3 and 5-year]
- Change of the Video Head Impulse Test (VHIT) from baseline [Срок оценки: 1, 3 and 5-year]
- Change of facial nerve function from baseline [Срок оценки: 1, 3 and 5-year]
- Change of taste function from baseline [Срок оценки: 6 and 12-month]
- Change of 36-Item Short Form Health Survey (SF-36) score from baseline [Срок оценки: 1, 3 and 5-year]
- Change of Penn Acoustic Neuroma Quality-of-Life (PANQOL) scale score from baseline [Срок оценки: 1, 3 and 5-year]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Швейцария · 1 центр
- Service d'ORL et Chirurge cervico-faciale, Hopitaux Universitaires de Genève — Geneva
Идентификаторы
NCT: NCT05641441 · 2022-01257