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CompletedNCT01018329Updated Dec 11, 2012

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

An interventional study of Magnetic Resonance Imaging and Diffusion Tensor Imaging in Brain Tumor, sponsored by Abramson Cancer Center at Penn Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-12-11.

Sponsored by Abramson Cancer Center at Penn Medicine · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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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.

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Conditions studied

  • Brain Tumor

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Keywords

  • Adult Brain Tumor
03

In context

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

This study's planned enrollment of 10 is below the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.

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Lead sponsor

Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    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.

    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

  • ProcedureMagnetic Resonance Imaging

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

  • ProcedureDiffusion Tensor Imaging
  • ProcedureMagnetic Resonance Spectroscopic Imaging

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

  • ProcedureDynamic Contract-Enhanced magnetic resonance imaging

    Also known as: DCE-MRI

  • ProcedureDiffusion-weighted magnetic resonance imaging

    Also known as: diffusion-weighted MRI

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What researchers measure

Primary outcomes

  1. Early brain tumor response

Secondary outcomes

  1. Early therapeutic-induced changes in normal surrounding brain

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Study locations

1 site
  • Abramson Cancer Center of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01018329
Lead sponsor
Abramson Cancer Center at Penn Medicine
Responsible party
Sponsor
First posted
Nov 23, 2009
Start date
Jul 2009
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Dec 11, 2012

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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