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Image-derived Prediction of Response to Chemo-radiation in Glioblastoma (IDEPREG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02329795
Recruitment Status : Terminated (Slow accrual)
First Posted : January 1, 2015
Last Update Posted : October 12, 2017
Information provided by (Responsible Party):
Michael Lundemann Jensen, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment
Glioblastoma Radiation: Radiotherapy Drug: Temozolomide

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).

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Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Standard chemoradiotherapy
Group to receive 60 Gy radiotherapy in 30 fractions with concomitant and adjuvant temozolomide.
Radiation: Radiotherapy
60 Gy in 30 fractions, 5 days a week, modulated arc therapy.

Drug: Temozolomide
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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary glioblastoma, eligible for chemoradiotherapy.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02329795

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Department of Oncology, Section for Radiotherapy, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
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Responsible Party: Michael Lundemann Jensen, Ph.d.-fellow, M.Sc., Rigshospitalet, Denmark Identifier: NCT02329795    
Other Study ID Numbers: 192/13
First Posted: January 1, 2015    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents