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

NCT ID: NCT01018329

Last Updated: 2012-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Brain Tumor

Keywords

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Adult Brain Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Diffusion Tensor Imaging

Intervention Type PROCEDURE

Magnetic Resonance Spectroscopic Imaging

Intervention Type PROCEDURE

Dynamic Contract-Enhanced magnetic resonance imaging

Intervention Type PROCEDURE

Diffusion-weighted magnetic resonance imaging

Intervention Type PROCEDURE

Interventions

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Magnetic Resonance Imaging

Intervention Type PROCEDURE

Diffusion Tensor Imaging

Intervention Type PROCEDURE

Magnetic Resonance Spectroscopic Imaging

Intervention Type PROCEDURE

Dynamic Contract-Enhanced magnetic resonance imaging

Intervention Type PROCEDURE

Diffusion-weighted magnetic resonance imaging

Intervention Type PROCEDURE

Other Intervention Names

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MRI,NMR imaging, NMRI, nuclear magnetic resonance imaging 1H-nuclear magnetic resonance spectroscopic imaging, Proton Magnetic Resonance Spectroscopic Imaging DCE-MRI diffusion-weighted MRI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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UPCC 12309

Identifier Type: -

Identifier Source: org_study_id