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

Brain Tumor Clinical Trial

Official title:

Multimodality Statistical Model of Early Response of High Grade Glioma to Radiation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018329
• Other study ID #: UPCC 12309
• Status: Completed
• Phase: N/A
• First received: November 19, 2009
• Last updated: December 10, 2012
• Start date: July 2009
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

Intervention

Procedure:
• Magnetic Resonance Imaging

• Diffusion Tensor Imaging

• Magnetic Resonance Spectroscopic Imaging

• Dynamic Contract-Enhanced magnetic resonance imaging

• Diffusion-weighted magnetic resonance imaging

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early brain tumor response			No
Secondary	Early therapeutic-induced changes in normal surrounding brain			No