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OpenTrials
Completed

NCT Number: NCT01018329

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging

Procedure

Other names: MRI,NMR imaging, NMRI, nuclear magnetic resonance imaging

diffusion tensor imaging

Procedure

magnetic resonance spectroscopic imaging

Procedure

Other names: 1H-nuclear magnetic resonance spectroscopic imaging, Proton Magnetic Resonance Spectroscopic Imaging

Dynamic Contract-Enhanced magnetic resonance imaging

Procedure

Other names: DCE-MRI

diffusion-weighted magnetic resonance imaging

Procedure

Other names: diffusion-weighted MRI

Primary outcomes

  1. Early brain tumor response

Secondary outcomes

  1. Early therapeutic-induced changes in normal surrounding brain

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 23, 2009
Registry last updated
Dec 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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