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Characterization of Serial Magnetic Resonance Spectroscopy Imaging in Patients With Malignant Glioma Undergoing Radiotherapy

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: NCT00125697
Recruitment Status : Completed
First Posted : August 2, 2005
Last Update Posted : July 18, 2016
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Brief Summary:
Malignant glioma is the most common primary brain tumor in adults. Despite aggressive therapy, less than 40% of these patients are expected to live beyond 5 years. The radiologic imaging of these tumors relies on computed tomography (CT) and magnetic resonance imaging (MRI) - these studies provide good anatomical information about the size and location of the tumor, but are unable to evaluate whether the tumor is still viable or contains metabolic activity, after surgery and, in particular, radiotherapy (RT). This complicates accurate understanding of the status of the tumor during a patient's follow-up. This study proposes to add magnetic resonance spectroscopy, a non-invasive imaging method which can monitor metabolic changes in the tumor, to regular imaging. Understanding the changes that occur in a tumor over the course of radiotherapy could help predict how well a treatment might work, and could also be useful in distinguishing a return of the tumor in an area of radiation damage before it would be obvious on regular imaging.

Condition or disease Intervention/treatment
Malignant Glioma Procedure: 3T MRI Scanning

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 49 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Serial Magnetic Resonance Spectroscopy Imaging in Patients With Malignant Glioma Undergoing Radiotherapy
Study Start Date : May 2005
Primary Completion Date : June 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Procedure: 3T MRI Scanning
    pre-radiation therapy, week 4 radiation therapy, 2 months post radiation therapy and every 4 months for the first year



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with histologically-proven glioma of the brain, including both malignant gliomas and high risk, low-grade gliomas as defined by Pignatti et al 2002
Criteria

Inclusion Criteria:

  • Patients must be older than 18 years of age.
  • Patients must have histologically proven malignant glioma of the brain.
  • Patients must have bi-directionally measurable enhancing residual disease by T1 weighted image.
  • Patients must be willing to undergo high dose radiotherapy to the brain for the treatment of their glial tumor.
  • Patients must be willing and able to comply with all study requirements.
  • The patient or legally authorized representative must fully understand all elements of informed consent, and sign the consent document.

Exclusion Criteria:

  • History of previous RT to the head and neck region.
  • History of lupus, scleroderma or RT hypersensitivity.
  • Co-existing medical condition precluding radiotherapy.
  • Psychiatric conditions precluding informed consent.
  • Medical or psychiatric conditions precluding MR studies (eg. pacemaker, aneurysm clips, neuro stimulator, cochlear implant, severe claustrophobia/anxiety).

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 ClinicalTrials.gov identifier (NCT number): NCT00125697


Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Wilson Roa, MD AHS Cancer Control Alberta

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00125697     History of Changes
Other Study ID Numbers: CNS-09-0022 / ethics 21388
First Posted: August 2, 2005    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: July 2016

Keywords provided by AHS Cancer Control Alberta:
malignant glioma
spectroscopy
magnetic resonance

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue