acoustic neuroma vestibular schwannoma
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • A decreased cognitive performance, defined as more than 1 standard deviation difference from reference groups. • cognitive change during follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Hearing and vestibular assessments. • (Health-Related) Quality of Life and mood status. • Radiological biomarkers/(f)MRI changes during follow-up. • Validation of two adjusted cognitive tests. | — |
Countries
Netherlands
Outcome results
None listed