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Imaging Biomarkers of Tissue Microstructure and Vasculature as Predictors of Glioblastoma Multiforme Response to Treatment With Bevacizumab for Progressive Disease


N/A
18 Years
80 Years
Open (Enrolling)
Both
Glioblastoma

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Trial Information

Imaging Biomarkers of Tissue Microstructure and Vasculature as Predictors of Glioblastoma Multiforme Response to Treatment With Bevacizumab for Progressive Disease


This study is for subjects with a diagnosis of a brain tumor called glioblastoma that is
being treated with bevacizumab. Bevacizumab is a drug that your doctor believes is the best
treatment option available to subjects at this time for this type of tumor. Bevacizumab
affects the growth of blood vessels by tumors such as glioblastoma, thus effectively
starving the tumor of oxygen and food.

Magnetic Resonance Imaging (MRI) is a test done by a machine in the radiology department
that takes pictures of your body using special magnets, rather than X-rays. With a new MRI
scan technique the investigators can take very, very detailed images of the vessel and tumor
structure. This project will allow us to compare the images of vessel and tumor structure to
the effectiveness of Bevacizumab as a treatment option. With this project the investigators
will hopefully develop an accurate way to predict whether or not Bevacizumab will be an
effective treatment option for patients.


Inclusion Criteria:



- Age between 18 and 80 years of age

- Progressive glioblastoma patients who have been planned to receive bevacizumab

- Karnofsky Performance Status 50 or above (vd. Appendix A)

- Established pathologic diagnosis of glioblastoma

- Prior treatment with Stupp regimen

- Neuroimaging progression of glioblastoma

- Able and willing to provide informed consent (or consent of a guardian)

Exclusion Criteria:

- Contraindication to MRI

- Contraindication to bevacizumab therapy

- Concurrent enrollment in other neuroimaging trials

- Prior therapy with bevacizumab

- Known hypersensitivity to MRI contrast

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

MRI to show differences between bevacizumab responses

Outcome Description:

The MRI parameters will help show the differences between bevacizumab-resposive and bevacizumab non-responsive recurrent glioblastoma

Outcome Time Frame:

1 month

Safety Issue:

No

Principal Investigator

Pierre Giglio, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of South Carolina

Authority:

United States: Food and Drug Administration

Study ID:

101652, MUSC

NCT ID:

NCT01604590

Start Date:

May 2012

Completion Date:

March 2014

Related Keywords:

  • Glioblastoma
  • Glioblastoma
  • Imaging Biomarkers
  • Bevacizumab
  • MRI
  • Glioblastoma

Name

Location

Medical University of South Carolina Charleston, South Carolina  29425-0721