89Zr-Bevacizumab PET/CT Imaging of Vestibular Schwannomas for the Prediction of Bevacizumab Treatment Effect in Patients With Symptomatic Neurofibromatosis Type 2

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

Bevacizumab can be an effective treatment for individuals with NF2 and improve different nerve functions (like hearing, tinnitus or balance problems) and the quality of life of NF2 patients. However, bevacizumab is not effective in all patients or all tumors, at the cost of moderate toxicity and considerable financial burden. Therefore, this observational study will validate an imaging biomarker method to predict bevacizumab efficacy in order to avoid adverse effects and high costs in non-responders to bevacizumab treatment. Patients will undergo standard-of-care treatment with the sole addition of a pre-treatment 89Zr-Bevacizumab PET/CT-scan. Per standard-of-care bevacizumab therapy is administered every three weeks for six months. To monitor treatment effect, follow-up is performed at 3-month intervals.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients aged 18 years or older

• Confirmed diagnosis of NF2 by revised Manchester criteria

• 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

Locations
Other Locations
Netherlands
Leiden University Medical Center
RECRUITING
Leiden
Contact Information
Primary
Jules PJ Douwes, MD
j.p.j.douwes@lumc.nl
715269111
Backup
Erik F Hensen, MD, PhD
e.f.hensen@lumc.nl
715269111
Time Frame
Start Date: 2022-10-20
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 15
Treatments
Bevacizumab
After determining eligibility, all patients will undergo standard-of-care treatment with the sole addition of a pre-treatment 89Zr-Bevacizumab PET/CT-scan. Patients will first receive 5 mg 89Zr-Bevacizumab 4 days before PET/CT scan. This is followed by standard-of-care intravenous 7.5mg/kg bevacizumab (Avastin) therapy, administered every three weeks for six months
Sponsors
Leads: Leiden University Medical Center

This content was sourced from clinicaltrials.gov