hereditary tumor syndrome NF
Conditions
Interventions
All patients will undergo intravenous infusion of 89Zr-Bevacizumab 4 days prior
to baseline PET/CT.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for treatment efficacy will be the correlation of the results of the pre-treatment 89Zr-Bevacizumab with the proportion of patients with confirmed hearing response (HR) and radiographic response (RR) to bevacizumab therapy. Secondary end points are correlations with patient-reported outcome measures (PROM), cranial nerve (dys)function, renal function and nontarget schwannoma response. Vestibulair function. | — |
Countries
Netherlands
Outcome results
None listed