search
Back to results

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

Primary Purpose

Brain Tumor

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnetic Resonance Imaging
Diffusion Tensor Imaging
Magnetic Resonance Spectroscopic Imaging
Dynamic Contract-Enhanced magnetic resonance imaging
Diffusion-weighted magnetic resonance imaging
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Tumor focused on measuring Adult Brain Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abramson Cancer Center of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

I

Arm 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.

Outcomes

Primary Outcome Measures

Early brain tumor response

Secondary Outcome Measures

Early therapeutic-induced changes in normal surrounding brain

Full Information

First Posted
November 19, 2009
Last Updated
December 10, 2012
Sponsor
Abramson Cancer Center at Penn Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT01018329
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor
Keywords
Adult Brain Tumor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
MRI,NMR imaging, NMRI, nuclear magnetic resonance imaging
Intervention Type
Procedure
Intervention Name(s)
Diffusion Tensor Imaging
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Spectroscopic Imaging
Other Intervention Name(s)
1H-nuclear magnetic resonance spectroscopic imaging, Proton Magnetic Resonance Spectroscopic Imaging
Intervention Type
Procedure
Intervention Name(s)
Dynamic Contract-Enhanced magnetic resonance imaging
Other Intervention Name(s)
DCE-MRI
Intervention Type
Procedure
Intervention Name(s)
Diffusion-weighted magnetic resonance imaging
Other Intervention Name(s)
diffusion-weighted MRI
Primary Outcome Measure Information:
Title
Early brain tumor response
Secondary Outcome Measure Information:
Title
Early therapeutic-induced changes in normal surrounding brain

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs