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

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Brief Title

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

Brief Summary

      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 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.
    


Study Type

Interventional


Primary Outcome

Early brain tumor response

Secondary Outcome

 Early therapeutic-induced changes in normal surrounding brain

Condition

Brain Tumor

Intervention

Magnetic Resonance Imaging

Study Arms / Comparison Groups

 I
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

10

Start Date

July 2009

Completion Date

December 2012

Primary Completion Date

December 2012

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01018329

Organization ID

UPCC 12309


Responsible Party

Sponsor

Study Sponsor

Abramson Cancer Center of the University of Pennsylvania


Study Sponsor

, , 


Verification Date

December 2012