NCT05685836

89Zr-Bevacizumab PET/CT Imaging in NF2 Patients

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neurofibromatosis 2

Interventions

Type	Name	Description
DRUG	Bevacizumab Zirconium Zr-89	See Arm description.

Timeline

• Start date: 2022-10-20
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-01-17
• Last updated: 2024-03-20

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study