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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01018329
First Posted: November 23, 2009
Last Update Posted: December 11, 2012
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.
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
  Purpose
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.

Condition Intervention
Brain Tumor 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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multimodality Statistical Model of Early Response of High Grade Glioma to Radiation Therapy

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Early brain tumor response

Secondary Outcome Measures:
  • Early therapeutic-induced changes in normal surrounding brain

Estimated Enrollment: 10
Study Start Date: July 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Magnetic Resonance Imaging
Other Name: MRI,NMR imaging, NMRI, nuclear magnetic resonance imaging
Procedure: Diffusion Tensor Imaging Procedure: Magnetic Resonance Spectroscopic Imaging
Other Name: 1H-nuclear magnetic resonance spectroscopic imaging, Proton Magnetic Resonance Spectroscopic Imaging
Procedure: Dynamic Contract-Enhanced magnetic resonance imaging
Other Name: DCE-MRI
Procedure: Diffusion-weighted magnetic resonance imaging
Other Name: diffusion-weighted MRI

Detailed Description:

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.

  Eligibility

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
Criteria

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
  Contacts and Locations
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): NCT01018329


Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
  More Information

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01018329     History of Changes
Other Study ID Numbers: UPCC 12309
First Submitted: November 19, 2009
First Posted: November 23, 2009
Last Update Posted: December 11, 2012
Last Verified: December 2012

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Adult Brain Tumor

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases