This study has been transitioned to CTIS with ID 2024-512860-75-00 check the CTIS register for the current data. The aim of this feasibility study is to validate pre-treatment [89Zr]-bevacizumab PET/CT as an imaging biomarker for prediction of…
ID
Source
Brief title
Condition
- Inner ear and VIIIth cranial nerve disorders
- Nervous system neoplasms benign
- Nervous system neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint for treatment efficacy will be the correlation of the
results of the pre-treatment 89Zr-Bevacizumab with the proportion of patients
with confirmed hearing response (HR) and radiographic response (RR) to
bevacizumab therapy. Secondary end points are correlations with
patient-reported outcome measures (PROM), cranial nerve (dys)function, renal
function and nontarget schwannoma response. Vestibulair function.
Secondary outcome
NA
Background summary
Neurofibromatosis type 2 (NF2) is an autosomal dominant tumor predisposition
syndrome caused by mutations in the NF2 gene. The pathognomonic hallmark of NF2
is development of bilateral vestibular schwannomas (VS) and many NF2 patients
also develop schwannomas of other nerves, multiple meningiomas and spinal
ependymomas. Nearly all VSs in NF2-patients express vascular endothelial growth
factor (VEGF), which can be selectively targeted by the monoclonal antibody
bevacizumab. Bevacizumab has been shown to improve hearing function and quality
of life of NF2 patients. However, not all VSs respond to bevacizumab and
bevacizumab may add substantial toxicity to the patient. To avoid unnecessary
toxicity and costs for non-responding individuals, a predictive biomarker
marker for treatment efficacy, such as 89Zr-Bevacizumab, could be very useful.
Study objective
This study has been transitioned to CTIS with ID 2024-512860-75-00 check the CTIS register for the current data.
The aim of this feasibility study is to validate pre-treatment
[89Zr]-bevacizumab PET/CT as an imaging biomarker for prediction of treatment
response to bevacizumab treatment in patients with NF2 related (vestibular)
schwannomas.
Study design
This pilot study is a phase II, prospective study. All patients will undergo
standard-of-care treatment with the sole addition of a pre-treatment
[89Zr]-bevacizumab PET/CT-scan. Patients will receive 5 mg / 37 MBq
[89Zr]-bevacizumab 4 days before PET/CT scan.
Intervention
All patients will undergo intravenous infusion of 89Zr-Bevacizumab 4 days prior
to baseline PET/CT.
Study burden and risks
All patients undergo one 89Zr-Bevacizumab-PET/CT scan of head/abdomen
(effective dose: <20 mSv). The procedures of PET-imaging involve patient
preparation, placement of intravenous catheter, intravenous injection of the
radiopharmaceutical and patient monitoring (total duration 90 min), followed by
PET-acquisition after 4 days (duration ~25 min). Occurrence of infusion-related
reaction (e.g. allergy) is unlikely. The radiation burden attached to each of
the procedure is 19,5 mSv. All other procedures are part of clinical protocol.
The proposed study does not include minors or incapacitated individuals. There
will be no individual benefit for enrolled subjects.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Patients aged 18 years or older
- Confirmed diagnosis of NF2 by revised Manchester criteria (appendix C)
- 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
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- 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
- Concurrend treatment with Everolimus
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-512860-75-00 |
| EudraCT | EUCTR2020-000156-35-NL |
| CCMO | NL72743.058.20 |