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

Completed

• Conditions: Glioblastoma
• Interventions: Radiation: Magnetic Resonance Imaging (MRI)

• Registration Number: NCT01604590
• Lead Sponsor: Medical University of South Carolina

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 Timeline

• Study First Submitted: 2012-05-21
• Study First Submitted QC: 2012-05-22
• Study First Posted: 2012-05-23
• Study Start: 2012-07
• Primary Completion: 2014-06
• Study Completion: 2014-09
• Status Verified: 2015-03
• Last Update Submitted: 2015-04-10
• Last Update Posted: 2015-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
glioblastoma patients on bevacizumab	Magnetic Resonance Imaging (MRI)	-

Primary Outcome Measures

Name	Time	Method
MRI to show differences between bevacizumab responses	1 month	The MRI parameters will help show the differences between bevacizumab-responsive and bevacizumab non-responsive recurrent glioblastoma

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival at 3 months	3 months	The progression of the subject's disease will be evaluated at 3 months.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States