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

NCT01018329 | Completed DMC

• 1 other identifier: UPCC 12309
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor

Keywords

Adult Brain Tumor

Outcome Measures

Primary Outcomes (1)

• Early brain tumor response

Secondary Outcomes (1)

• Early therapeutic-induced changes in normal surrounding brain

Study Arms (1)

I

EXPERIMENTAL

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.

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

Interventions

Magnetic Resonance Imaging PROCEDURE

Also known as: MRI,NMR imaging, NMRI, nuclear magnetic resonance imaging

I

Diffusion Tensor Imaging PROCEDURE

I

Magnetic Resonance Spectroscopic Imaging PROCEDURE

Also known as: 1H-nuclear magnetic resonance spectroscopic imaging, Proton Magnetic Resonance Spectroscopic Imaging

I

Dynamic Contract-Enhanced magnetic resonance imaging PROCEDURE

Also known as: DCE-MRI

I

Diffusion-weighted magnetic resonance imaging PROCEDURE

Also known as: diffusion-weighted MRI

I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Magnetic Resonance Spectroscopy; Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: November 23, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

US (1)