Imaging Biomarkers of Tissue Microstructure and Vasculature as Predictors of Glioblastoma Multiforme
1 other identifier
observational
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2012
CompletedFirst Posted
Study publicly available on registry
May 23, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedApril 13, 2015
March 1, 2015
1.9 years
May 21, 2012
April 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MRI to show differences between bevacizumab responses
The MRI parameters will help show the differences between bevacizumab-responsive and bevacizumab non-responsive recurrent glioblastoma
1 month
Secondary Outcomes (1)
Progression Free Survival at 3 months
3 months
Study Arms (1)
glioblastoma patients on bevacizumab
Interventions
Magnetic Resonance Imaging (MRI) will be used to compare bevacizumab to the images of vessel and tumor structure.
Eligibility Criteria
Male and female subjects, 18-80 years old with progressive glioblastoma who receive bevacizumab
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre Giglio, MD
Medical University of South Carolina
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2012
First Posted
May 23, 2012
Study Start
July 1, 2012
Primary Completion
June 1, 2014
Study Completion
September 1, 2014
Last Updated
April 13, 2015
Record last verified: 2015-03