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

NCT ID: NCT01604590

Last Updated: 2015-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-09-30

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.

Conditions

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Glioblastoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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glioblastoma patients on bevacizumab

Magnetic Resonance Imaging (MRI)

Intervention Type RADIATION

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

Interventions

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Magnetic Resonance Imaging (MRI)

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

Intervention Type RADIATION

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Giglio, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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101652, MUSC

Identifier Type: -

Identifier Source: org_study_id

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