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Determining the tumor uptake of labelled bevacizumab in children with high grade or diffuse intrinsic pontine glioma on PET scans.


- candidate number13121
- NTR NumberNTR3518
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-jul-2012
- Secondary IDsNL34922.000.11 CCMO
- Public TitleDetermining the tumor uptake of labelled bevacizumab in children with high grade or diffuse intrinsic pontine glioma on PET scans.
- Scientific TitleExploration of VEGF-expression and 89Zirconium-bevacizumab uptake in paediatric high grade glioma and diffuse intrinsic pontine glioma imaged by PET.
- ACRONYM89Zr-Bmab PET in pHGG & DIPG
- hypothesisIs there VEGF-expression in DIPG & HGG measured by the tumor uptake of Zr-bevacizumab?
- Healt Condition(s) or Problem(s) studiedHigh grade glioma, Intrinsic pontine glioma
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2011
- planned closingdate1-mrt-2014
- Target number of participants15
- InterventionsThis is a diagnostic PET study. The labelled antibody is 89Zr-Bevacizumab.
- Primary outcomeVEGF-expression measured by Standard Uptake Values of 89Zr-Bevacizumab in pHGG and DIPG.
- Secondary outcome1. Optimal moment of scanning obtained by five patients with positive 89Zr-bevacizumab uptake;
2. Body biodistribution and dosimetry of 89Zr-bevacizumab.
- Timepoints89Zr-bevacizumab is injected and PET scans are performed at 1, 72 and 144 hours post-injection.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Gertjan J.L. Kaspers
- CONTACT for SCIENTIFIC QUERIESDr. Gertjan J.L. Kaspers
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsJansen MH, van Vuurden DG, Vandertop WP, Kaspers GJ. Diffuse intrinsic pontine gliomas: A systematic update on clinical trials and biology. Cancer Treat Rev. 2012;38:27-35

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.
- Brief summaryPaediatric 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.
- Main changes (audit trail)
- RECORD9-jul-2012 - 27-jul-2012


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