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

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. Identifier: NCT00250211
Recruitment Status : Completed
First Posted : November 8, 2005
Last Update Posted : February 24, 2016
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glioblastoma Glioma Procedure: Functional MRI imaging and tomotherapy Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2005
Actual Primary Completion Date : March 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. determine tumor response and pattern of failure using functional MRI imaging [ Time Frame: Study completion ]
  2. time to disease progression [ Time Frame: Study completion ]

Secondary Outcome Measures :
  1. distinguish residual tumor from treatment-related necrosis [ Time Frame: study completion ]
  2. survival
  3. acute late toxicity of tomotherapy and hypofractionation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00250211

Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Cross Cancer Institute
Principal Investigator: Bassam Abdulkarim, MD AHS Cancer Control Alberta

Responsible Party: AHS Cancer Control Alberta Identifier: NCT00250211     History of Changes
Other Study ID Numbers: CNS-09-0027 / ethics 21780
First Posted: November 8, 2005    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: October 2011

Keywords provided by AHS Cancer Control Alberta:
magnetic resonance imaging, functional
radiation therapy
functional imaging
concurrent chemoradiation

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents