Prospective Evaluation of Vestibular Schwannoma Irradiatio

Recruiting

Conditions: acoustic neuroma
vestibular schwannoma
10022396
10029209

Registration Number: NL-OMON54239

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 145

Inclusion Criteria

- age of at least 18 years
- patient with vestibular schwannoma (radiologically proven diagnosis) with a
radiotherapy treatment indication or active surveillance for control group A
- able to provide written informed consent, as determined by the treating
physician
- ability to comply with the protocol, including cognitive testing and imaging
- written informed consent

Exclusion Criteria

- previous surgical excision or radiotherapy for vestibular schwannoma
- incapacitated adults
- contra-indication for MRI
- impaired kidney function (eGFR known to be under 30 mm/min)
- Gadolinium allergy
- any prior cranial radiotherapy or chemotherapy
- any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule
in the participating hospitals
- any serious medical condition that could interfere with follow-up
- severe aphasia, (functional) analphabetism or language barrier interfering
with assessing endpoints
- pregnancy, lactation or intention to become pregnant during the study, since
this is a contra-indication for undergoing Gadolinium-contrast enhanced MRI

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• A decreased cognitive performance, defined as more than 1 standard deviation<br /><br>difference from reference groups.<br /><br>• cognitive change during follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Hearing and vestibular assessments.<br /><br>• (Health-Related) Quality of Life and mood status.<br /><br>• Radiological biomarkers/(f)MRI changes during follow-up.<br /><br>• Validation of two adjusted cognitive tests.</p><br>