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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Imaging Biomarkers of Tissue Microstructure and Vasculature as Predictors of Glioblastoma Multiforme Response to Treatment With Bevacizumab for Progressive Disease

Conditions
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Glioblastoma

Intervention / Treatment
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* Radiation: Magnetic Resonance Imaging (MRI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| glioblastoma patients on bevacizumab<br> | Radiation: Magnetic Resonance Imaging (MRI)<br>* Magnetic Resonance Imaging (MRI) will be used to compare bevacizumab to the images of vessel and tumor structure.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glioblastoma, Imaging Biomarkers, Bevacizumab, MRI