No registrations found.
ID
Source
Brief title
Health condition
Diffuse intrinsic pontine glioma
Pediatric high grade glioma
Malignant glioma
Hooggradig glioom
Ponsglioom
Sponsors and support
Intervention
Outcome measures
Primary outcome
VEGF-expression measured by Standard Uptake Values of 89Zr-Bevacizumab in pHGG and DIPG.
Secondary outcome
1. Optimal moment of scanning obtained by five patients with positive 89Zr-bevacizumab uptake;
2. Body biodistribution and dosimetry of 89Zr-bevacizumab.
Background summary
Paediatric high grade gliomas (pHGG) including diffuse intrinsic pontine gliomas (DIPG) have a poor prognosis. PET imaging with labelled antibodies enables drug distribution investigations and non-invasive target expression studies. pHGG and DIPG highly express vascular endothelial growth factor (VEGF) on RNA level, which is involved in mitogenic, angiogenic, and permeability enhancing processes. Monoclonal antibody bevacizumab inhibits VEGF-A and showed efficacy in adult glioma and to a lesser extend in pHGG. Bevacizumab is labelled to Zirconium-89, a positron emitter with a long half-time which is preferable because of its safety, purity and stable binding to its antibody and relatively low costs. In adults, 89Zr-bevacizumab could be used safely in humans and was shown to visualise targets precisely. In this study, bevacizumab is administered in a microdose at 1/100th of the therapeutic dose in pHGG and DIPG. PET scans are performed at 1, 72 and 144 hours post-injection. We expect that PET-imaging of 89Zr-bevacizumab may help to select patients more likely to respond to bevacizumab therapy.
Study objective
Is there VEGF-expression in DIPG & HGG measured by the tumor uptake of Zr-bevacizumab?
Study design
89Zr-bevacizumab is injected and PET scans are performed at 1, 72 and 144 hours post-injection.
Intervention
This is a diagnostic PET study. The labelled antibody is 89Zr-Bevacizumab.
De Boelelaan 1117
Gertjan J.L. Kaspers
De Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4442420
gjl.kaspers@vumc.nl
De Boelelaan 1117
Gertjan J.L. Kaspers
De Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4442420
gjl.kaspers@vumc.nl
Inclusion criteria
1. DIPG (MRI confirmed, biopsy not required) de novo;
2. De novo biopsy proven HGG patients with minimal residual tumor of 0.5 mm in each dimension or;
3. pHGG & DIPG patients with progressive disease after radiotherapy;
4. Age between 4 and 18 years;
5. Able to lay down quiet for 30 minutes.
Exclusion criteria
1. Chemotherapy or radiotherapy in the past two weeks;
2. Previous administration of bevacizumab or another anti-VEGF drug;
3. Known hypersensitivity against humanized monoclonal antibodies;
4. Neurofibromatosis type I.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3370 |
| NTR-old | NTR3518 |
| CCMO | NL34922.000.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON38105 |
Summary results
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Van Dongen GA, Visser GW, Lub-de Hooge MN, de Vries EG, Perk LR. Immuno-PET: a navigator in monoclonal antibody development and applications. Oncologist 2007:12: 1379-1389.