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

Abramson Cancer Center at Penn Medicine

Status: Completed

Conditions: Brain Tumor

Treatments: Procedure: Diffusion-weighted magnetic resonance imaging; Procedure: Magnetic Resonance Spectroscopic Imaging; Procedure: Diffusion Tensor Imaging; Procedure: Dynamic Contract-Enhanced magnetic resonance imaging; Procedure: Magnetic Resonance Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT01018329

UPCC 12309

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

I

Experimental group

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.

Treatment:

Procedure: Magnetic Resonance Imaging

Procedure: Dynamic Contract-Enhanced magnetic resonance imaging

Procedure: Diffusion Tensor Imaging

Procedure: Diffusion-weighted magnetic resonance imaging

Procedure: Magnetic Resonance Spectroscopic Imaging