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

October 11, 2017 updated by: Michael Lundemann Jensen, Rigshospitalet, Denmark

Image-derived Prediction of Response to Chemo-radiation in Patients With Glioblastoma

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.

Study Overview

Status

Terminated

Conditions

Intervention / 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).

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of Oncology, Section for Radiotherapy, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with primary glioblastoma, eligible for chemoradiotherapy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • Temodar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months post radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months post radiotherapy
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
1 week before start of chemoradiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

December 16, 2014

First Submitted That Met QC Criteria

December 29, 2014

First Posted (Estimate)

January 1, 2015

Study Record Updates

Last Update Posted (Actual)

October 12, 2017

Last Update Submitted That Met QC Criteria

October 11, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 192/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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