Image-derived Prediction of Response to Chemo-radiation in Glioblastoma (IDEPREG)
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|ClinicalTrials.gov Identifier: NCT02329795|
Recruitment Status : Terminated (Slow accrual)
First Posted : January 1, 2015
Last Update Posted : October 12, 2017
|Condition or disease||Intervention/treatment|
|Glioblastoma||Radiation: Radiotherapy Drug: Temozolomide|
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).
|Study Type :||Observational|
|Actual Enrollment :||16 participants|
|Official Title:||Image-derived Prediction of Response to Chemo-radiation in Patients With Glioblastoma|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Group to receive 60 Gy radiotherapy in 30 fractions with concomitant and adjuvant temozolomide.
60 Gy in 30 fractions, 5 days a week, modulated arc therapy.
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.
Other Name: Temodar
- 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.
- DICE-similarity coefficient and percentage overlap of 64Cu-ATSM and contrast-enhanced T1-weighted MRI [ Time Frame: 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 [ Time Frame: 1 week before start of chemoradiotherapy ]Lactate measured by MR spectroscopy is compared to metabolic uptake of 64Cu-ATSM-PET
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329795
|Department of Oncology, Section for Radiotherapy, Rigshospitalet|
|Copenhagen, Denmark, 2100|