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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01604590
Recruitment Status : Completed
First Posted : May 23, 2012
Last Update Posted : April 13, 2015
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Tracking Information
First Submitted Date May 21, 2012
First Posted Date May 23, 2012
Last Update Posted Date April 13, 2015
Study Start Date July 2012
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 2, 2013)
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
Original Primary Outcome Measures
 (submitted: May 22, 2012)
MRI to show differences between bevacizumab responses [ Time Frame: 1 month ]
The MRI parameters will help show the differences between bevacizumab-resposive and bevacizumab non-responsive recurrent glioblastoma
Change History Complete list of historical versions of study NCT01604590 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 22, 2012)
Progression Free Survival at 3 months [ Time Frame: 3 months ]
The progression of the subject's disease will be evaluated at 3 months.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Imaging Biomarkers of Tissue Microstructure and Vasculature as Predictors of Glioblastoma Multiforme
Official Title Imaging Biomarkers of Tissue Microstructure and Vasculature as Predictors of Glioblastoma Multiforme Response to Treatment With Bevacizumab for Progressive Disease
Brief Summary 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.
Detailed Description

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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Male and female subjects, 18-80 years old with progressive glioblastoma who receive bevacizumab
Condition Glioblastoma
Intervention Radiation: Magnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging (MRI) will be used to compare bevacizumab to the images of vessel and tumor structure.
Study Groups/Cohorts glioblastoma patients on bevacizumab
Intervention: Radiation: Magnetic Resonance Imaging (MRI)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 10, 2015)
13
Original Estimated Enrollment
 (submitted: May 22, 2012)
20
Actual Study Completion Date September 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01604590
Other Study ID Numbers 101652, MUSC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Medical University of South Carolina
Study Sponsor Medical University of South Carolina
Collaborators Not Provided
Investigators
Principal Investigator: Pierre Giglio, MD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date March 2015