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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01604590
Enrollment
13
Registered
2012-05-23
Start date
2012-07-31
Completion date
2014-09-30
Last updated
2015-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma

Keywords

Glioblastoma, Imaging Biomarkers, Bevacizumab, MRI

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.

Interventions

RADIATIONMagnetic Resonance Imaging (MRI)

Magnetic Resonance Imaging (MRI) will be used to compare bevacizumab to the images of vessel and tumor structure.

Sponsors

Medical University of South Carolina
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MRI to show differences between bevacizumab responses1 monthThe MRI parameters will help show the differences between bevacizumab-responsive and bevacizumab non-responsive recurrent glioblastoma

Secondary

MeasureTime frameDescription
Progression Free Survival at 3 months3 monthsThe progression of the subject's disease will be evaluated at 3 months.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026