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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01604590
First received: May 21, 2012
Last updated: July 31, 2014
Last verified: July 2014

May 21, 2012
July 31, 2014
July 2012
September 2014   (final data collection date for primary outcome measure)
MRI to show differences between bevacizumab responses [ Time Frame: 1 month ] [ Designated as safety issue: No ]
The MRI parameters will help show the differences between bevacizumab-responsive and bevacizumab non-responsive recurrent glioblastoma
MRI to show differences between bevacizumab responses [ Time Frame: 1 month ] [ Designated as safety issue: No ]
The MRI parameters will help show the differences between bevacizumab-resposive and bevacizumab non-responsive recurrent glioblastoma
Complete list of historical versions of study NCT01604590 on ClinicalTrials.gov Archive Site
Progression Free Survival at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
The progression of the subject's disease will be evaluated at 3 months.
Same as current
Not Provided
Not Provided
 
Imaging Biomarkers of Tissue Microstructure and Vasculature as Predictors of Glioblastoma Multiforme
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. This study will use a new MRI technique to compare the images of blood vessels and tumor structure to the effectiveness of bevacizumab.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Male and female subjects, 18-80 years old with progressive glioblastoma who receive bevacizumab

Glioblastoma
Radiation: Magnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging (MRI) will be used to compare bevacizumab to the images of vessel and tumor structure.
glioblastoma patients on bevacizumab
Intervention: Radiation: Magnetic Resonance Imaging (MRI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01604590
101652, MUSC
No
Medical University of South Carolina
Medical University of South Carolina
Not Provided
Principal Investigator: Pierre Giglio, MD Medical University of South Carolina
Medical University of South Carolina
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP