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Recruiting
NCT05685836
89Zr-Bevacizumab PET/CT Imaging in NF2 Patients
Conditions: Neurofibromatosis 2
Sex: All
Ages: 18 Years – N/A
Enrollment: 15
Sponsor: Leiden University Medical Center
Location: Netherlands
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 Criteria
Inclusion Criteria:Patients aged 18 years or olderConfirmed diagnosis of NF2 by revised Manchester criteriaProvided written informed consentPatients 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 treatmentExclusion 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 studyConcurrent treatment with Everolimus
Source: ClinicalTrials.gov (NCT05685836). StuddyBuddy aggregates publicly available trial information.