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Magnetic Resonance Spectroscopic Imaging (MRS) and Tumor Perfusion of Human Glioblastoma Treated With Concurrent Radiation Therapy and Temozolomide

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00250211
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AHS Cancer Control Alberta
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bassam Abdulkarim, MD
Principal Investigator Affiliation AHS Cancer Control Alberta
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Completed
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma, Glioma

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Cross Cancer Institute, Edmonton, Alberta, Canada

Status

Address

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2