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Completed

NCT Number: NCT00250211

Magnetic Resonance Spectroscopic Imaging (MRS) and Tumor Perfusion 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.

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional MRI imaging and tomotherapy

Procedure

Primary outcomes

  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 outcomes

  1. distinguish residual tumor from treatment-related necrosis

    Time frame: study completion

  2. survival

  3. acute late toxicity of tomotherapy and hypofractionation

Sponsors and collaborators

Lead sponsor

AHS Cancer Control Alberta

Other

Collaborators

  • Cross Cancer Institute

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Nov 8, 2005
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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