Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
15 participants
OBSERVATIONAL
2022-10-20
2024-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Bevacizumab Zirconium Zr-89
See Arm description.
Interventions
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Bevacizumab Zirconium Zr-89
See Arm description.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 known allergy to substances used in this study
* Concurrent treatment with Everolimus
18 Years
ALL
No
Sponsors
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Leiden University Medical Center
OTHER
Responsible Party
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Hans Gelderblom
Prof. A.J. Gelderblom, MD, PhD, Head of Medical Oncology, Principal Investigator
Principal Investigators
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Hans AJ Gelderblom, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Center
Locations
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Leiden University Medical Center
Leiden, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020-000156-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NF2PET
Identifier Type: -
Identifier Source: org_study_id
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