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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
  Purpose

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 Intervention Phase
Glioblastoma
Glioma
 Procedure: Functional MRI imaging and tomotherapy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Alberta Health Services:

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

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

Enrollment: 26
Study Start Date: March 2005
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00250211

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: Bassam Abdulkarim, MD Alberta Health Services
  More Information

No publications provided

Responsible Party: Alberta Health Services
ClinicalTrials.gov Identifier: NCT00250211     History of Changes
Other Study ID Numbers: CNS-09-0027 / ethics 21780
Study First Received: November 4, 2005
Last Updated: October 18, 2011
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
magnetic resonance imaging, functional
radiation therapy
temozolomide
functional imaging
concurrent chemoradiation

Additional relevant MeSH terms:
Glioblastoma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
 Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013