Imaging to predict treatment response 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
This study is testing a new imaging method to see if it can help predict which patients with Neurofibromatosis 2 will benefit from a treatment called bevacizumab.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Drugs / interventions | bevacizumab |
| Locations | 1 site (Leiden, Zuid-Holland) |
| Trial ID | NCT05685836 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate a novel imaging biomarker method using 89Zr-Bevacizumab PET/CT scans to predict the efficacy of bevacizumab treatment in patients with Neurofibromatosis 2 (NF2). By identifying patients who are likely to respond to the treatment, the study seeks to minimize unnecessary exposure to potential side effects and financial burdens associated with ineffective therapy. Participants will receive standard bevacizumab treatment while undergoing imaging to monitor their response at regular intervals over six months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of NF2 and measurable disease who are planned for bevacizumab treatment.
Not a fit: Patients who are pregnant, have contraindications for PET and MRI, or are allergic to study substances may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify NF2 patients who will benefit from bevacizumab, improving treatment outcomes and reducing unnecessary side effects.
How similar studies have performed: While the approach of using imaging biomarkers to predict treatment response is gaining traction, this specific application in NF2 with bevacizumab is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Leiden, Zuid-Holland
- Leiden University Medical Center — Leiden, Zuid-Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Hans AJ Gelderblom, MD, PhD — Leiden University Medical Center
- Study coordinator: Jules PJ Douwes, MD
- Email: j.p.j.douwes@lumc.nl
- Phone: 715269111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.