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

NCT ID: NCT02329795

Last Updated: 2017-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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).

Conditions

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Glioblastoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Standard chemoradiotherapy

Group to receive 60 Gy radiotherapy in 30 fractions with concomitant and adjuvant temozolomide.

Radiotherapy

Intervention Type RADIATION

60 Gy in 30 fractions, 5 days a week, modulated arc therapy.

Temozolomide

Intervention Type DRUG

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.

Interventions

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Radiotherapy

60 Gy in 30 fractions, 5 days a week, modulated arc therapy.

Intervention Type RADIATION

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.

Intervention Type DRUG

Other Intervention Names

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Temodar

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Michael Lundemann Jensen

Ph.d.-fellow, M.Sc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Oncology, Section for Radiotherapy, Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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192/13

Identifier Type: -

Identifier Source: org_study_id