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.

Study Overview

• Status: Completed
• Conditions: Glioblastoma
• Intervention / Treatment: Radiation: Magnetic Resonance Imaging (MRI)

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
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
glioblastoma patients on bevacizumab	Radiation: Magnetic Resonance Imaging (MRI); Magnetic Resonance Imaging (MRI) will be used to compare bevacizumab to the images of vessel and tumor structure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival at 3 months	The progression of the subject's disease will be evaluated at 3 months.	3 months

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Pierre Giglio, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: May 21, 2012
• First Submitted That Met QC Criteria: May 22, 2012
• First Posted (Estimate): May 23, 2012

Study Record Updates

• Last Update Posted (Estimate): April 13, 2015
• Last Update Submitted That Met QC Criteria: April 10, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: MRI; Bevacizumab; Glioblastoma; Imaging Biomarkers
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: 101652, MUSC