Magnetic Resonance Imaging in Evaluating Response to RadiationTherapy in Patients With High Grade Glioma

Official Title: “Multimodality Statistical Model of Early Response of High Grade Glioma to Radiation Therapy”

RATIONALE: Diagnostic procedures, such as magnetic resonance imaging, may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This clinical trial is studying magnetic resonance imaging in response to radiation therapy in patients with high grade glioma.

Detailed DescriptionOBJECTIVES:

I. To develop a multimodality statistical model to act as a surrogate marker scheme of early changes in high grade glioma patients undergoing radiation therapy, using conventional MRI, MR diffusion tensor imaging, perfusion, permeability, and spectroscopic imaging while incorporating the radiation dose calculations delivered locally and the results of a clinical questionnaire into the model.

II. To assess treatment response to tumor and normal tissue changes. OUTLINE: Patients undergo multimodality MRI imaging at baseline, weeks 1, 2, 3, 5, and 6, and then 4-6 weeks after completion of radiation therapy.

Intervention(s) in this Clinical Trial

• Procedure: Magnetic Resonance Imaging
• Procedure: Diffusion Tensor Imaging
• Procedure: Magnetic Resonance Spectroscopic Imaging
• Procedure: Dynamic Contract-Enhanced magnetic resonance imaging
• Procedure: Diffusion-weighted magnetic resonance imaging

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: I
  • Patients undergo multimodality MRI imaging at baseline, weeks 1, 2, 3, 5, and 6 and then 4-6 weeks after completion of radiation therapy.Patients undergo MRI imaging at baseline, weeks 1, 2, 3, 5, 6 and then 6 weeks after radiation therapy.

Primary Measures

• Early brain tumor response
  • Safety Issue?: No

Secondary Measures

• Early therapeutic-induced changes in normal surrounding brain
  • Safety Issue?: No

Inclusion Criteria:

• Patients being treated for diagnosed with high grade glioma (WHO grade III or IV) at the University of Pennsylvania Medical Center who will be undergoing radiation therapy to the brain
• Patient or legal representative able to provide written informed consent
• Adult males and nonpregnant females

Exclusion Criteria:

• Vulnerable populations as specified (including pregnant patients, prisoners, patients with pacemakers or metallic implants)
• Patients with renal failure
• Patients with any condition considered a contraindication to MRI

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Abramson Cancer Center of the University of Pennsylvania Other

Overall Clinical Trial Officials and Contacts

Overall Contact: Christos Davatzikos, PhD (215)-662-2812 admin@ctsrmc.org

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01018329

Study ID Number: UPCC 12309

ClinicalTrials.gov Identifier: NCT01018329

Health Authority: United States: Institutional Review Board