Glioblastoma
Conditions
Brief summary
This study seeks to investigate if advanced image-analysis of diagnostic scans, can be used to predict how aggressive brain tumors (glioblastoma) respond to standard chemo- and radiation treatment.
Detailed description
Generally, response prediction models seeks to predict time to an event, e.g. time-to-progression and/or overall survival. The aim of this study is to explore the feasibility of establishing an individualized response model, that, based on several morphologic, physiologic and metabolic parameters extracted from computed tomography (CT), positron emission tomography (PET) and magnetic resonance imaging (MRI), is able to predict the tumor response at the level of an imaging voxel, using machine learning techniques. Imaging modalities include MRI, PET/CT with 18F-fluroethyltyrosine (18F-FET), and PET/MRI with 64Cu-diacetyl-bis(N4-methylthiosemicarbazone) (64Cu-ATSM).
Interventions
RADIATIONRadiotherapy
60 Gy in 30 fractions, 5 days a week, modulated arc therapy.
DRUGTemozolomide
Concomitant: 75 mg/m2 5 days a week from start of radiotherapy. Adjuvant: 150/200 mg/m2 in 5 days per 28 days in 6 months.
Sponsors
Rigshospitalet, Denmark
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed, primary supratentorial glioblastoma (WHO grade IV).
Exclusion criteria
* No informed consent can be obtained * Inability to undergo MRI examination, due to metal implants, pacemaker etc. * Not eligible for Stupp-regimen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of predicted response | 3 months post radiotherapy | Tumor response is measured as contrast-enhancing tumor on T1-weighted MRI and by metabolic active tumor using 18F-fluroethyl-tyrosine (FET)-PET. Pre-treatment risk map is constructed using machine learning methods and compared to post-treatment scans. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DICE-similarity coefficient and percentage overlap of 64Cu-ATSM and contrast-enhanced T1-weighted MRI | 3 months post radiotherapy | Pre-chemoradiotherapy 64Cu-ATSM-PET is used as a surrogate marker for hypoxia and compared to treatment response, measured as contrast-enhancing tumor on T1-weighted MRI |
| Correlation (volume and maximum values) between lactate and hypoxia | 1 week before start of chemoradiotherapy | Lactate measured by MR spectroscopy is compared to metabolic uptake of 64Cu-ATSM-PET |
Countries
Denmark
Outcome results
None listed