Clinical trial NCT01604590: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioblastoma
Keywords: Glioblastoma
Imaging Biomarkers
Bevacizumab
MRI
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2012-05-23
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female subjects, 18-80 years old with progressive glioblastoma who receive bevacizumab

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.

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

Primary outcomes:
measure: MRI to show differences between bevacizumab responses
timeFrame: 1 month
Secondary outcomes:
measure: Progression Free Survival at 3 months
timeFrame: 3 months
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Pierre Giglio, MD
role: PRINCIPAL_INVESTIGATOR
References: