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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01018329
First received: November 19, 2009
Last updated: December 10, 2012
Last verified: December 2012

November 19, 2009
December 10, 2012
July 2009
December 2012   (final data collection date for primary outcome measure)
Early brain tumor response [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01018329 on ClinicalTrials.gov Archive Site
Early therapeutic-induced changes in normal surrounding brain [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Magnetic Resonance Imaging in Evaluating Response to RadiationTherapy in Patients With High Grade Glioma
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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Brain Tumor
  • 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
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.
Interventions:
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01018329
UPCC 12309
Yes
Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Not Provided
Not Provided
Abramson Cancer Center of the University of Pennsylvania
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP