89Zr-Bevacizumab PET/CT Imaging in NF2 Patients

Leiden University Medical Center (LUMC)

Status: Enrolling

Conditions: Neurofibromatosis 2

Treatments: Drug: Bevacizumab Zirconium Zr-89

Study type: Observational

Funder types: Other

Identifiers

NCT05685836

2020-000156-35 (EudraCT Number)

NF2PET

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Concurrent treatment with Everolimus

Trial design

15 participants in 1 patient group

Bevacizumab

Description:

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

Treatment:

Drug: Bevacizumab Zirconium Zr-89