An observational study in Glioblastoma Multiforme, sponsored by Technische Universität Dresden. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-18.
Sponsored by Technische Universität Dresden · Observational
Local recurrence is a major problem of clinical treatment of glioblastoma multiforme (GBM). Today a very sensitive imaging method to detect glioblastoma is [11C]MET Positron emission tomography (PET), where in some patients also tumour manifestations can be detected that are not visible in MRI investigations.
The aim of the study is to investigate the association of high [11C]MET tracer uptake before postoperative radiochemotherapy and concurrent temozolomide (TMZ) with time to recurrence in patients with glioblastoma multiforme. Also site of recurrence will be correlated with the [11C]MET imaging before and early during radiochemotherapy. All imaging information will be included in treatment planning or treatment decisions.
The study provides a basis for later radiation dose escalation trials on the base of [11C]MET imaging.
The current study aims to investigate the association of high [11C]MET tracer uptake before postoperative radiochemotherapy and concurrent temozolomide (TMZ) with time to recurrence in patients with glioblastoma multiforme (GBM).
[11C]MET-PET is expected to provide diagnostic (quantitative and spatial information) as well as prognostic information, to monitor treatment, to help stratification of patients for radiotherapeutic interventions such as dose-painting in order to optimize clinical applications and potentially improve the treatment outcome.
This study aims to provide the basis (e.g. optimal threshold value, sensitivity, specificity of MET uptake) for later intervention trials for treatment intensification, e.g. proton boost irradiation based on specific biomarkers.
The trial is a one-arm single-center, non-randomized observational (biomarker) study. After resection or biopsy, patients with newly diagnosed glioblastoma multiforme will receive a [11C]MET-PET/MRI scan before start of concurrent radiochemotherapy (\~1-4 weeks after surgery). A fusion with the planning CT for irradiation treatment planning will be performed. Postoperative radiotherapy will be applied in daily fractions of 2 Gy given 5 days per week for 6 weeks, for a total dose of 60 Gy (50 Gy and a boost of 10 Gy), with concomitant administration of daily Temozolomide (75 mg/m2 p.o.) from the 1st day to the last day of radiotherapy. Follow up with [11C]MET-PET/MRI will be performed every 3 months until recurrence or until death of the patient.
The uptake of [11C]MET-PET (as standard uptake value - SUV) in tumour and in normal contralateral grey matter before start of concurrent radiochemotherapy will be determined. For each tumour, the ratio between tracer uptake in the tumor and contralateral gray matter will be calculated (lesion-to-gray matter ratio [l/g]).
Primary end point will be time to recurrence (TTR) as function of [11C]MET uptake before chemoradiotherapy. Secondary endpoints will be overall survival; toxicity; C-Index/ROC curve (sensitivity, specificity, optimal threshold for normal/tumour tissue index), necrosis rate; site of recurrence.
The primary analysis will use the Cox proportional hazard model to establish the linear association between [11C]-MET and time-to-recurrence using a one-sided alpha = 0.1.
Parallel translational studies with orthotopic GBM xenografts (generated from the patients material in the trial) in nude mice will be performed in our laboratory to evaluate [11C]MET-PET as a tool for tailoring high precision radiotherapy. Histological, biological and genetic studies are planned to validate the imaging finding and to explore the underlying mechanisms.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 102 is above the median of 60 across 188 observational studies indexed under Glioblastoma.
Browse Glioblastoma studies →Technische Universität Dresden is the lead sponsor of 237 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with the diagnosis of glioblastoma multiforme
Exclusion Criteria:
glioblastoma patients with indication to radiochemotherapy
Radiation: Radiochemotherapy
postoperative radiochemotherapy 60 Gy/ Temozolomide
Time to recurrence as function of [11C]MET uptake before postoperative radiochemotherapy
Time frame: participants will be followed until tumour recurrence, an expected average of 7 months
overall survival
Time frame: expected average 15 months
Plan to share: No
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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Technische Universität Dresden