AzTrials
AzTrials

Neurofibromatosis 2NCT05685836

89Zr-Bevacizumab PET/CT Imaging in NF2 Patients

An observational study of Neurofibromatosis 2, run by Leiden University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neurofibromatosis 2
What is being tested?
Bevacizumab Zirconium Zr-89
Type of treatment
Injection or infusion
How many people
15 participants
Where
1 siteNetherlands
Study dates
20 Oct 2022to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients with a confirmed diagnosis of NF2 and candidate for bevacizumab therapy.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Jules PJ Douwes, MD contact

715269111 ext. +31

j.p.j.douwes@lumc.nl

Erik F Hensen, MD, PhD contact

715269111 ext. +31

e.f.hensen@lumc.nl

Netherlands1 site, 1 recruiting

  • Leiden University Medical Center

    Leiden, South Holland, 2333ZA

    Jules PJ Douwes, MD, 715269111 ext. +31, j.p.j.douwes@lumc.nl

    Hans AJ Gelderblom, MD, PhD, 715269111 ext. +31, a.j.gelderblom@lumc.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: 89Zr-Bevacizumab PET/CT Imaging of Vestibular Schwannomas for the Prediction of Bevacizumab Treatment Effect in Patients With Symptomatic Neurofibromatosis Type 2

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.

Being tested
Bevacizumab Zirconium Zr-89
Keywords
neurofibromatosis 2, NF2-related schwannomatosis, vestibular schwannoma, bevacizumab, 89Zr-Bevacizumab, PET/CT imaging, hearing
Medical subject headings
Neurofibromatosis 2, Neuroma, Acoustic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bevacizumab Zirconium Zr-89Drug

    Also called Avastin, 89Zr-Bevacizumab, Bevacizumab

    See Arm description.

Study groups in NCT05685836
Study groupRoleWhat they receive
BevacizumabAfter 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
Receives: Drug: Bevacizumab Zirconium Zr-89

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hearing response (HR) - WRS

    Word Recognition Score (WRS), % at x dB

    Measured: Baseline

  2. Hearing response (HR) - WRS

    Word Recognition Score (WRS), % at x dB

    Measured: 3 months

  3. Hearing response (HR) - WRS

    Word Recognition Score (WRS), % at x dB

    Measured: 6 months

  4. Hearing response (HR) - PTA

    Pure Tone Average (PTA), in dB

    Measured: Baseline

  5. Hearing response (HR) - PTA

    Pure Tone Average (PTA), in dB

    Measured: 3 months

  6. Hearing response (HR) - PTA

    Pure Tone Average (PTA), in dB

    Measured: 6 months

  7. Radiographic response (RR) - tumor volumetry on MRI

    Size change in volumetric MRI (REiNS criteria); volumetry in mL or mm

    Measured: Baseline

  8. Radiographic response (RR) - tumor volumetry on MRI

    Size change in volumetric MRI (REiNS criteria); volumetry in mL or mm

    Measured: 3 months

  9. Radiographic response (RR) - tumor volumetry on MRI

    Size change in volumetric MRI (REiNS criteria); volumetry in mL or mm

    Measured: 6 months

  10. Radiographic response (RR) - ADC

    Apparent diffusion coefficient (ADC) of tumor of interest, in mm2/s, on greatest diameter

    Measured: Baseline

  11. Radiographic response (RR) - ADC

    Apparent diffusion coefficient (ADC) of tumor of interest, in mm2/s, on greatest diameter

    Measured: 3 months

  12. Radiographic response (RR) - ADC

    Apparent diffusion coefficient (ADC) of tumor of interest, in mm2/s, on greatest diameter

    Measured: 6 months

  13. Radiographic response (RR) - Microbleeds

    Location and number of microbleeds

    Measured: Baseline

  14. Radiographic response (RR) - Microbleeds

    Location and number of microbleeds

    Measured: 3 months

  15. Radiographic response (RR) - Microbleeds

    Location and number of microbleeds

    Measured: 6 months

  16. Radiographic response (RR) - Diffusion restriction

    Diffusion restriction, yes / no

    Measured: Baseline

  17. Radiographic response (RR) - Diffusion restriction

    Diffusion restriction, yes / no

    Measured: 3 months

  18. Radiographic response (RR) - Diffusion restriction

    Diffusion restriction, yes / no

    Measured: 6 months

Secondary outcomes (18)

  1. Vestibular Function

    Video-Head Impulse Test (vHIT)

    Measured: Baseline

  2. Vestibular Function

    Video-Head Impulse Test (vHIT)

    Measured: 3 months

  3. Vestibular Function

    Video-Head Impulse Test (vHIT)

    Measured: 6 months

  4. Vestibular Function

    cervical Vestibular Evoked Myogenic Potential (cVEMP) test

    Measured: Baseline

  5. Vestibular Function

    cervical Vestibular Evoked Myogenic Potential (cVEMP) test

    Measured: 3 months

  6. Vestibular Function

    cervical Vestibular Evoked Myogenic Potential (cVEMP) test

    Measured: 6 months

  7. Vestibular Function

    Caloric test

    Measured: Baseline

  8. Vestibular Function

    Caloric test

    Measured: 3 months

  9. Vestibular Function

    Caloric test

    Measured: 6 months

  10. Patient reported outcome measures (PROM)

    Questionnaire on Quality of Life, and presence of symptoms

    Measured: Baseline

  11. Patient reported outcome measures (PROM)

    Questionnaire on Quality of Life, and presence of symptoms

    Measured: 3 months

  12. Patient reported outcome measures (PROM)

    Questionnaire on Quality of Life, and presence of symptoms

    Measured: 6 months

  13. 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.

    Measured: Baseline

  14. 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.

    Measured: 3 months

  15. 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.

    Measured: 6 months

  16. Renal function

    Creatinine clearance (CrCl), eGFR (mL/minute, ref. >90)

    Measured: Baseline

  17. Renal function

    Creatinine clearance (mmol/L), eGFR (mL/minute)

    Measured: 3 months

  18. Renal function

    Creatinine clearance (mmol/L), eGFR (mL/minute)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2023
  2. Study start20 Oct 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05685836
Sponsor's protocol ID
NF2PET
Other IDs
2020-000156-35
Status last verified
Mar 2024
First submitted
5 Dec 2022
Last updated
20 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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 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.

    PubMed 41951260

Questions about this trial

What is this clinical trial studying?

An observational study of Neurofibromatosis 2, run by Leiden University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jules PJ Douwes, MD (715269111 ext. +31, j.p.j.douwes@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hearing response (HR) - WRS (time frame: Baseline). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05685836, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in