Image-derived Prediction of Response to Chemo-radiation in Patients With Glioblastoma
Overview
- Phase
- Not Applicable
- Intervention
- Radiotherapy
- Conditions
- Glioblastoma
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Sensitivity and specificity of predicted response
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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).
Investigators
Michael Lundemann Jensen
Ph.d.-fellow, M.Sc.
Rigshospitalet, Denmark
Eligibility Criteria
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
Arms & Interventions
Standard chemoradiotherapy
Group to receive 60 Gy radiotherapy in 30 fractions with concomitant and adjuvant temozolomide.
Intervention: Radiotherapy
Standard chemoradiotherapy
Group to receive 60 Gy radiotherapy in 30 fractions with concomitant and adjuvant temozolomide.
Intervention: Temozolomide
Outcomes
Primary Outcomes
Sensitivity and specificity of predicted response
Time Frame: 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 Outcomes
- DICE-similarity coefficient and percentage overlap of 64Cu-ATSM and contrast-enhanced T1-weighted MRI(3 months post radiotherapy)
- Correlation (volume and maximum values) between lactate and hypoxia(1 week before start of chemoradiotherapy)