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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00125697
First received: July 29, 2005
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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 Intervention
Malignant Glioma
Procedure: 3T MRI Scanning

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Serial Magnetic Resonance Spectroscopy Imaging in Patients With Malignant Glioma Undergoing Radiotherapy

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Estimated Enrollment: 30
Study Start Date: May 2005
Estimated Study Completion Date: June 2015
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
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
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00125697     History of Changes
Other Study ID Numbers: CNS-09-0022 / ethics 21388
Study First Received: July 29, 2005
Last Updated: June 10, 2014
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on July 31, 2014