JOURNAL ONKOLOGIE – STUDIE

Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05641441

Studienbeginn:
Januar 2023

Letztes Update:
07.07.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Neurilemmoma, Neuroma, Acoustic, Ototoxicity

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital, Geneva

Collaborator:
-

Kontakt

Pascal Senn
Kontakt:
Phone: 0223728244
E-Mail: pascal.senn@hcuge.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Service d'ORL et Chirurge cervico-faciale, Hopitaux Universitaires de Genève
1205 Geneva
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Pascal Senn
Phone: 0223728244
E-Mail: pascal.senn@hcuge.ch» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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 outcome:

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)

Studien-Arme

Stereotactic radiosurgery group
Patients with unilateral Vestibular Schwannoma treated with stereotactic radiosurgery, as proposed by the institution's skull base tumor board independently of the study.
Wait and scan group
Patients with unilateral Vestibular Schwannoma followed with an MRI-based observation strategy, as proposed by the institution's skull base tumor board independently of the study.

Geprüfte Regime

Stereotactic radiosurgery:
Stereotactic radiosurgery

Quelle: ClinicalTrials.gov

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