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OpenTrials
Completed

NCT Number: NCT01604590

Imaging Biomarkers of Tissue Microstructure and Vasculature as Predictors of Glioblastoma Multiforme

This study is for subjects with a diagnosis of a brain tumor called glioblastoma that is being treated with bevacizumab. This study will use a new MRI technique to compare the images of blood vessels and tumor structure to the effectiveness of bevacizumab.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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 radiation and chemotherapy
  • 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
  • Females who are nursing or pregnant

Treatment and study plan

Magnetic resonance imaging (MRI)

Radiation

Magnetic Resonance Imaging (MRI) will be used to compare bevacizumab to the images of vessel and tumor structure.

Primary outcomes

  1. MRI to show differences between bevacizumab responses

    Time frame: 1 month

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

Secondary outcomes

  1. Progression Free Survival at 3 months

    Time frame: 3 months

    The progression of the subject's disease will be evaluated at 3 months.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 23, 2012
Registry last updated
Apr 13, 2015

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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