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Trial Title:
89Zr-Bevacizumab PET/CT Imaging in NF2 Patients
NCT ID:
NCT05685836
Condition:
Neurofibromatosis 2
Conditions: Official terms:
Neurofibromatoses
Neurofibromatosis 1
Neurofibroma
Neurofibromatosis 2
Bevacizumab
89Zr-bevacizumab
Conditions: Keywords:
neurofibromatosis 2
NF2-related schwannomatosis
vestibular schwannoma
bevacizumab
89Zr-Bevacizumab
PET/CT imaging
hearing
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Bevacizumab Zirconium Zr-89
Description:
See Arm description.
Arm group label:
Bevacizumab
Other name:
Avastin
Other name:
89Zr-Bevacizumab
Other name:
Bevacizumab
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. 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.
Criteria for eligibility:
Study pop:
Adult patients with a confirmed diagnosis of NF2 and candidate for bevacizumab therapy.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Leiden University Medical Center
Address:
City:
Leiden
Zip:
2333ZA
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Jules PJ Douwes, MD
Phone:
715269111
Phone ext:
+31
Email:
j.p.j.douwes@lumc.nl
Contact backup:
Last name:
Hans AJ Gelderblom, MD, PhD
Phone:
715269111
Phone ext:
+31
Email:
a.j.gelderblom@lumc.nl
Start date:
October 20, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Leiden University Medical Center
Agency class:
Other
Source:
Leiden University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05685836
