Glioblastoma Clinical Trial
Official title:
An Open-label, Single Arm Study to Explore Whether Potential Image Biomarkers Correlate With Efficacy of Bevacizumab Combined With Conventional Therapy in Newly Diagnosed Glioblastoma
This is a single-center, open-label, single arm study to explore whether potential image
biomarkers correlate with efficacy of bevacizumab combined with conventional therapy in
newly diagnosed glioblastoma.
Despite the increase in therapies available, the median survival of patients with
glioblastoma multiforme (GBM) remains less than 15 months.
The phase III pivotal study in newly diagnosed GBM also met its co-primary endpoint of
progression-free survival (PFS) which further confirm the efficacy of bevacizumab in GBM.
Early predicting the efficacy of bevacizumab combined with conventional therapy in newly
diagnosed glioblastoma could help us to identify the suitable patients to receive suitable
treatment in GBM. Thus, characterizing the blood flow and blood volume in the tumor and
their changes during therapy might provide information on vasculature growth or
collapse,edema formation, tumor growth, and/or cell death(necrosis) .We decided to
investigate whether the estimation of blood circulation in tumor, using MRI,PET could be
used as a surrogate marker to predict the early response of GBM to bevacizumab.
Several previous studies have demonstrated that the relative cerebral blood volume (rCBV)
correlated with the histologic grade of gliomas and investigated the prognostic value of the
tumor CBV for survival.In current study, We hypothesized that, the temporal changes during
anti-angiogenesis therapy in specific regions of high and low perfusion in glioblastoma
might predict the efficacy of bevacizumab.Since there is no mature PET tracer directly image
Vascular Endothelial Growth Factor (VEGF) in China,we use
18F-Galacto-arginine-glycine-aspartic acid (RGD)—— a new tracer for PET imaging of αvβ3 by
testing Standardized uptake value mean (SUVmean),Standardized uptake value max (SUVmax) and
tumor to non-tumor tissue ratios (T/NT) to indirectly reflect the VEGF expression. The
integrin αvβ3 is an important receptor affecting tumor growth, local invasiveness, and
metastatic potential. Specifically, αvβ3 is highly expressed on activated endothelial cells
during angiogenesis.
Therefore, in the pilot study, we use dynamic contrast enhanced magnetic resonance imaging
(DCE-MRI),dynamic susceptibility-contrast magnetic resonance imaging (DSC-MRI) and
18F-Galacto-RGD PET to explore the potential image biomarkers of bevacizumab used in newly
diagnosed glioblastoma.
20 patients with newly diagnosed histopathologically confirmed glioblastoma (WHO Grade IV) after surgery will be enrolled in the study. All of the patients will receive conventional concurrent chemoradiation and adjuvant temozolomide plus bevacizumab begin > 3 weeks and ≤ 5 weeks after surgery. ;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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