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

Glioblastoma Clinical Trial

— IDEPREG  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02329795
• Other study ID #: 192/13
• Status: Terminated
• Phase: N/A
• First received: December 16, 2014
• Last updated: October 11, 2017
• Start date: October 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2017
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of Oncology, Section for Radiotherapy, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of predicted response	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	DICE-similarity coefficient and percentage overlap of 64Cu-ATSM and contrast-enhanced T1-weighted MRI	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
Secondary	Correlation (volume and maximum values) between lactate and hypoxia	Lactate measured by MR spectroscopy is compared to metabolic uptake of 64Cu-ATSM-PET	1 week before start of chemoradiotherapy