Clinical trial · Observational
89Zr-Bevacizumab PET/CT Imaging 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neurofibromatosis 2 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab Zirconium Zr-89 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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
- interventionNames
- Drug: Bevacizumab Zirconium Zr-89
Primary outcomes (18)
- measure
- Hearing response (HR) - WRS
- timeFrame
- Baseline
- description
- Word Recognition Score (WRS), % at x dB
- measure
- Hearing response (HR) - WRS
- timeFrame
- 3 months
- description
- Word Recognition Score (WRS), % at x dB
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDouwes JPJ, Tops AL, Dibbets-Schneider P, Verbist BM, Fuentealba Bassaletti CA, Jansen JC, Koetsier KS, van Dam VS, Koot RW, van Velden FHP, Pool M, Vugts D, Schopman JE, Goeman JJ, De Geus-Oei LF, Hensen EF, Gelderblom H. [89Zr]bevacizumab PET/CT imaging of vestibular schwannomas for the prediction of bevacizumab treatment effect in patients with symptomatic NF2-related schwannomatosis: a study protocol for a phase II single centre, prospective, feasibility trial. BMJ Open. 2026 Apr 8;16(4):e114812. doi: 10.1136/bmjopen-2025-114812. PMID 41951260