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Magnetic Resonance Spectroscopic Imaging (MRS) and Tumor Perfusion of Human Glioblastoma Treated With Concurrent Radiation Therapy and Temozolomide

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00250211
First received: November 4, 2005
Last updated: October 18, 2011
Last verified: October 2011
History of Changes

November 4, 2005
October 18, 2011
March 2005
March 2011   (final data collection date for primary outcome measure)
  • determine tumor response and pattern of failure using functional MRI imaging [ Time Frame: Study completion ]
  • time to disease progression [ Time Frame: Study completion ]
  • -determine tumor response and pattern of failure using functional MRI imaging
  • -time to disease progression
Complete list of historical versions of study NCT00250211 on ClinicalTrials.gov Archive Site
  • distinguish residual tumor from treatment-related necrosis [ Time Frame: study completion ]
  • survival
  • acute late toxicity of tomotherapy and hypofractionation
  • -distinguish residual tumor from treatment-related necrosis
  • -survival
  • -acute late toxicity of tomotherapy and hypofractionation
Not Provided
Not Provided
 
Magnetic Resonance Spectroscopic Imaging (MRS) and Tumor Perfusion of Human Glioblastoma Treated With Concurrent Radiation Therapy and Temozolomide
Multimodality Functional Imaging (MRS and Tumor Perfusion) Predicts Tumor Migration, Invasiveness, and Patterns of Failure of Human Glioblastoma Treated With Concurrent Radiation Therapy and Temozolomide

The purpose of this study is to learn whether 3 tesla (3T) MRI functional imaging will map a tumor more accurately allowing a more targeted delivery of radiation. The investigators hope to learn whether tomotherapy will be able to deliver higher radiation doses safely to the tumor while sparing the surrounding normal tissue.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Glioblastoma
  • Glioma
Procedure: Functional MRI imaging and tomotherapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
April 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed glioblastoma multiforme
  • Ages 18-65
  • Karnofsky Performance Scale (KPS) equal to or less than 70
  • Minimal neurological deficit
  • Eligible for concurrent temozolomide chemotherapy

Exclusion Criteria:

  • Prior radiation therapy to hand or neck area, chemotherapy, or radiosensitizer
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00250211
CNS-09-0027 / ethics 21780
Yes
Alberta Health Services
Alberta Health Services
Not Provided
Principal Investigator: Bassam Abdulkarim, MD Alberta Health Services
Alberta Health Services
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP