BEVACIZUMAB ZIRCONIUM ZR-89 for Neurofibromatosis type 2 (NF2-related schwannomatosis)|Vestibular schwannoma

Inclusion criteria

• {"criterion_text":"- Patients aged 18 years or older"}
• {"criterion_text":"- Confirmed diagnosis of NF2 by revised Manchester criteria (appendix C)"}
• {"criterion_text":"- Provided written informed consent"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Eligible and planned for bevacizumab treatment"}

Exclusion criteria

• {"criterion_text":"- Patients with a contra-indication for PET and MRI, such as pregnancy and metal elements."}
• {"criterion_text":"- Patients with a known allergy to substances used in this study"}
• {"criterion_text":"- Concurrent treatment with Everolimus"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Correlation between pre-treatment 89Zr-Bevacizumab PET/CT results and the proportion of patients with confirmed hearing response (HR) and radiographic response (RR) to bevacizumab therapy."}

Secondary endpoints

• {"endpoint_text":"- Correlations of pre-treatment 89Zr-Bevacizumab PET/CT imaging with patient-reported outcome measures (PROM), vestibular function, cranial nerve (dys)function, kidney function and nontarget schwannoma response after bevacizumab treatment in NF2-patients.","definition_or_measurement_approach":"Correlation analyses between pre-treatment 89Zr-Bevacizumab PET/CT imaging metrics and patient-reported outcome measures (PROM), vestibular function tests, cranial nerve function assessments, kidney function measures, and responses of non-target schwannomas following bevacizumab treatment."}

Netherlands

Earliest CTIS Part Ii Submission Date

23-09-2024

Latest Decision Or Authorization Date

01-10-2024

Processing Time Days

8

Number Of Sites

1

Number Of Participants

24

Primary sponsor

Full Name

Leids Universitair Medisch Centrum (LUMC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands