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

This study is currently recruiting participants.

Verified by Alberta Cancer Board, November 2007

First Received: July 29, 2005 Last Updated: September 22, 2008 History of Changes

Sponsored by:	Alberta Cancer Board
Information provided by:	Alberta Cancer Board
ClinicalTrials.gov Identifier:	NCT00125697

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

MedlinePlus related topics: Cancer Radiation Therapy

U.S. FDA Resources

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

Further study details as provided by Alberta Cancer Board:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	30
Study Start Date:	May 2005
Estimated Study Completion Date:	July 2008

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125697

Contacts

Contact: Wilson Roa, MD

780-432-8783

wilsonro@cancerboard.ab.ca

Locations

Canada, Alberta
Cross Cancer Institute	Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Clinical Reseach Unit 780-989-8152 clinical_trials_cci@cancerboard.ab.ca
Principal Investigator: Wilson Roa, MD

Sponsors and Collaborators

Alberta Cancer Board

Investigators

Principal Investigator:

Wilson Roa, MD

Alberta Cancer Board

More Information

No publications provided

Study ID Numbers:	CNS-09-0022
Study First Received:	July 29, 2005
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00125697 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Alberta Cancer Board:

malignant glioma
spectroscopy
magnetic resonance

Study placed in the following topic categories:

Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009