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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.
 
ClinicalTrials.gov Identifier: NCT02329795
Recruitment Status : Terminated (Slow accrual)
First Posted : January 1, 2015
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Lundemann Jensen, Rigshospitalet, Denmark

Tracking Information
First Submitted Date December 16, 2014
First Posted Date January 1, 2015
Last Update Posted Date October 12, 2017
Study Start Date October 2014
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 29, 2014)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02329795 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 29, 2014)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Image-derived Prediction of Response to Chemo-radiation in Glioblastoma
Official Title Image-derived Prediction of Response to Chemo-radiation in Patients With Glioblastoma
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with primary glioblastoma, eligible for chemoradiotherapy.
Condition 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.
    Other Name: Temodar
Study Groups/Cohorts Standard chemoradiotherapy
Group to receive 60 Gy radiotherapy in 30 fractions with concomitant and adjuvant temozolomide.
Interventions:
  • Radiation: Radiotherapy
  • Drug: Temozolomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: April 23, 2017)
16
Original Estimated Enrollment
 (submitted: December 29, 2014)
44
Actual Study Completion Date October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT02329795
Other Study ID Numbers 192/13
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Michael Lundemann Jensen, Rigshospitalet, Denmark
Study Sponsor Rigshospitalet, Denmark
Collaborators Not Provided
Investigators Not Provided
PRS Account Rigshospitalet, Denmark
Verification Date October 2017