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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000156-35 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab Zirconium Zr-89 | Drug | See Arm description. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Hearing response (HR) - WRS | Word Recognition Score (WRS), % at x dB | Baseline |
| Hearing response (HR) - WRS | Word Recognition Score (WRS), % at x dB | 3 months |
| Hearing response (HR) - WRS | Word Recognition Score (WRS), % at x dB | 6 months |
| Hearing response (HR) - PTA | Pure Tone Average (PTA), in dB | Baseline |
| Hearing response (HR) - PTA | Pure Tone Average (PTA), in dB | 3 months |
| Hearing response (HR) - PTA | Pure Tone Average (PTA), in dB | 6 months |
| Radiographic response (RR) - tumor volumetry on MRI | Size change in volumetric MRI (REiNS criteria); volumetry in mL or mm | Baseline |
| Radiographic response (RR) - tumor volumetry on MRI | Size change in volumetric MRI (REiNS criteria); volumetry in mL or mm | 3 months |
| Radiographic response (RR) - tumor volumetry on MRI |
| Measure | Description | Time Frame |
|---|---|---|
| Vestibular Function | Video-Head Impulse Test (vHIT) | Baseline |
| Vestibular Function | Video-Head Impulse Test (vHIT) | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with a confirmed diagnosis of NF2 and candidate for bevacizumab therapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jules PJ Douwes, MD | Contact | 715269111 | +31 | j.p.j.douwes@lumc.nl |
| Erik F Hensen, MD, PhD | Contact | 715269111 | +31 | e.f.hensen@lumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Hans AJ Gelderblom, MD, PhD | Leiden University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Recruiting | Leiden | South Holland | 2333ZA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41951260 | Derived | Douwes 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 HA. [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. |
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| ID | Term |
|---|---|
| D016518 | Neurofibromatosis 2 |
| D009464 | Neuroma, Acoustic |
| ID | Term |
|---|---|
| D009442 | Neurilemmoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| C580636 | 89Zr-bevacizumab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Size change in volumetric MRI (REiNS criteria); volumetry in mL or mm |
| 6 months |
| Radiographic response (RR) - ADC | Apparent diffusion coefficient (ADC) of tumor of interest, in mm2/s, on greatest diameter | Baseline |
| Radiographic response (RR) - ADC | Apparent diffusion coefficient (ADC) of tumor of interest, in mm2/s, on greatest diameter | 3 months |
| Radiographic response (RR) - ADC | Apparent diffusion coefficient (ADC) of tumor of interest, in mm2/s, on greatest diameter | 6 months |
| Radiographic response (RR) - Microbleeds | Location and number of microbleeds | Baseline |
| Radiographic response (RR) - Microbleeds | Location and number of microbleeds | 3 months |
| Radiographic response (RR) - Microbleeds | Location and number of microbleeds | 6 months |
| Radiographic response (RR) - Diffusion restriction | Diffusion restriction, yes / no | Baseline |
| Radiographic response (RR) - Diffusion restriction | Diffusion restriction, yes / no | 3 months |
| Radiographic response (RR) - Diffusion restriction | Diffusion restriction, yes / no | 6 months |
| Vestibular Function | Video-Head Impulse Test (vHIT) | 6 months |
| Vestibular Function | cervical Vestibular Evoked Myogenic Potential (cVEMP) test | Baseline |
| Vestibular Function | cervical Vestibular Evoked Myogenic Potential (cVEMP) test | 3 months |
| Vestibular Function | cervical Vestibular Evoked Myogenic Potential (cVEMP) test | 6 months |
| Vestibular Function | Caloric test | Baseline |
| Vestibular Function | Caloric test | 3 months |
| Vestibular Function | Caloric test | 6 months |
| Patient reported outcome measures (PROM) | Questionnaire on Quality of Life, and presence of symptoms | Baseline |
| Patient reported outcome measures (PROM) | Questionnaire on Quality of Life, and presence of symptoms | 3 months |
| Patient reported outcome measures (PROM) | Questionnaire on Quality of Life, and presence of symptoms | 6 months |
| Physical examination | General neurological examination is performed to assess if the patient has neurological symptoms, if any. The examination is done according to standard clinical care and has a descriptive nature. Cranial nerve (dys)function, including House Brackmann scale for the facial nerve (n. VII) and trigeminal nerve function (n. V), including presence of neuralgia and hypoesthesia, are described in more detail. | Baseline |
| Physical examination | General neurological examination is performed to assess if the patient has neurological symptoms, if any. The examination is done according to standard clinical care and has a descriptive nature. Cranial nerve (dys)function, including House Brackmann scale for the facial nerve (n. VII) and trigeminal nerve function (n. V), including presence of neuralgia and hypoesthesia, are described in more detail. | 3 months |
| Physical examination | General neurological examination is performed to assess if the patient has neurological symptoms, if any. The examination is done according to standard clinical care and has a descriptive nature. Cranial nerve (dys)function, including House Brackmann scale for the facial nerve (n. VII) and trigeminal nerve function (n. V), including presence of neuralgia and hypoesthesia, are described in more detail. | 6 months |
| Renal function | Creatinine clearance (CrCl), eGFR (mL/minute, ref. >90) | Baseline |
| Renal function | Creatinine clearance (mmol/L), eGFR (mL/minute) | 3 months |
| Renal function | Creatinine clearance (mmol/L), eGFR (mL/minute) | 6 months |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D017253 | Neurofibromatoses |
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D009463 | Neuroma |
| D009386 | Neoplastic Syndromes, Hereditary |
| D000160 | Vestibulocochlear Nerve Diseases |
| D012181 | Retrocochlear Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010039 | Otorhinolaryngologic Neoplasms |
| D003390 | Cranial Nerve Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D020752 | Neurocutaneous Syndromes |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D010524 | Peripheral Nervous System Neoplasms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |