89Zr-Bevacizumab PET/CT Imaging in NF2 Patients

Sponsor
Leiden University Medical Center
Study ID
NCT05685836
Status
Unknown

Conditions

  • Neurofibromatosis 2

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Jan 17, 2023
Start date
Oct 20, 2022
Status verified
Mar 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
15 participants (estimated)

Arms

  • Arm: 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

Primary Outcome Measure

Hearing response (HR) - WRS [ Time Frame: Baseline ]

Central Contacts

Related Studies