89Zr-Bevacizumab PET/CT imaging of vestibular schwannomas for the prediction of bevacizumab treatment effect in patients with symptomatic neurofibromatosis type 2.
- Conditions
- hereditary tumor syndromeNF1002239610029209
- Registration Number
- NL-OMON52411
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Patients aged 18 years or older
- Confirmed diagnosis of NF2 by revised Manchester criteria (appendix C)
- Provided written informed consent
- Patients must have measurable disease, defined as at least one VS > 0.4 ml
(on volumetric analysis) that can be accurately measured by contrast-enhanced
T1-weighted cranial MRI scan.
- Eligible and planned for bevacizumab treatment
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Patients with a contra-indication for PET and MRI, such as pregnancy and
metal elements.
- Patients with a known allergy to substances used in this study
- Concurrend treatment with Everolimus
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint for treatment efficacy will be the correlation of the<br /><br>results of the pre-treatment 89Zr-Bevacizumab with the proportion of patients<br /><br>with confirmed hearing response (HR) and radiographic response (RR) to<br /><br>bevacizumab therapy. Secondary end points are correlations with<br /><br>patient-reported outcome measures (PROM), cranial nerve (dys)function, renal<br /><br>function and nontarget schwannoma response. Vestibulair function.</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>