Measuring Non-Enhancing Glioblastoma Progression

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ClinicalTrials.gov Identifier: NCT00777686

Recruitment Status : Completed

First Posted : October 22, 2008

Last Update Posted : March 30, 2012

Sponsor:

Information provided by (Responsible Party):

M.D. Anderson Cancer Center

Study Description

Brief Summary:

The goal of this clinical research study is to learn if magnetic resonance imaging with magnetic resonance spectroscopy ("MRI/MRS" scanning) can measure any extra growth in the tumor that does not show up on regular MRI images. This study procedure will be performed on patients with recurrent glioblastoma who are either being treated with chemotherapy that blocks blood vessel growth, or will soon begin this type of chemotherapy.

Condition or disease	Intervention/treatment
Brain Tumor Glioblastoma	Procedure: MRI/MRS Scan

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Detailed Description:

The Study Procedures:

MRI scanning is commonly used to check the status of glioblastoma. In this study, MRI scanning will also be used to try to better understand how chemotherapy that blocks blood vessel growth may be affecting the status of the glioblastoma.

The timing of all MRI scans for this study will be done on schedule for routine patient care. There will not be any extra MRI scans performed, but an MRS portion to the MRI scans will be added. The MRS results will be used in this study to look at the chemical differences between the cancerous and normal tissue, in order to try to better understand how your chemotherapy may be working.

Screening Tests:

Before you can begin this study, you will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:

Blood (about 1 teaspoon) will be drawn for routine tests.
Women who are able to have children must have a negative blood (about 1 teaspoon) pregnancy test.

MRI/MRS Scanning:

If you are found to be eligible to take part in this study, you will have an MRI/MRS scan of the brain. The first of these scans will be performed before the chemotherapy starts (either before your first cycle of this type of chemotherapy or before your next cycle, depending on whether you were receiving this type of chemotherapy before the study or not). After that, an MRI/MRS scan will be repeated at Weeks 8 and 16 after the beginning of chemotherapy.

The MRI/MRS scans will follow the same procedure and use the same MRI scanner machine as a regular MRI scan, but will take about an additional 10 minutes. You will lie still on your back with your head placed within the openings of the scanner. A contrast solution, which helps make the tumor visible, will be given through a needle in your vein. The scanning procedure should take about an hour at each visit.

The results of the MRI/MRS scans will not be used to affect your course of treatment.

Tissue Collection:

If your regular doctor recommends that the tumor be surgically removed, the surgery will be discussed with you in detail and you will sign a separate informed consent form for it. Leftover tissue that was removed during the surgery will be collected and used as part of this study. The tissue will be used to further check the status of the disease, and it will be compared with the MRI/MRS images.

Biomarker Testing:

In this study, you will also have blood drawn for biomarker testing. Biomarkers are chemical "markers" in the blood, other body fluids, or tissue that may be related to the status of disease and/or the effects of treatment. This blood (about 2 teaspoons each time) will be drawn before the chemotherapy starts and then every 8 weeks while you are on study. The blood draws will occur on the same days as the MRI/MRS scanning.

Length of Study Participation:

You will continue having blood drawn for biomarker testing every 8 weeks, unless you stop taking this type of chemotherapy that blocks blood vessel growth. In that case, you will be taken off study.

If you do have surgery, your participation in this study will end after the surgery. If you are unable to have surgery, your participation will end after your last MRI/MRS scan.

This is an investigational study. MRI scanning is an FDA approved and commercially available procedure for checking the status of glioblastoma. At this time and for this purpose, MRS scanning is being used in research only.

Up to 18 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Design

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Study Type :	Observational
Actual Enrollment :	7 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Quantifying Progression of Non-Enhancing Tumor in Patients With Recurrent Glioblastoma Treated With Antiangiogenic Agents
Study Start Date :	August 2008
Actual Primary Completion Date :	March 2011
Actual Study Completion Date :	March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Genetic and Rare Diseases Information Center resources: Glioblastoma Gliosarcoma Glioma Neuroepithelioma

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
MRI/MRS Scanning Magnetic resonance imaging with magnetic resonance spectroscopy (MRI/MRS Scanning)	Procedure: MRI/MRS Scan MRI/MRS brain scan with intravenous contrast prior to chemotherapy, then repeated every 8 weeks. Other Names: magnetic resonance spectroscopy MR Imaging MR MRI/MRS scanning MRI/MRS MRI MRS

Outcome Measures

Primary Outcome Measures :

Functional MR Measurements [ Time Frame: Baseline, Every 8 weeks and at Off Study ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients, 18 years or older, with "recurrent" intracranial glioblastoma or gliosarcoma being treated with chemotherapy or will be treated.

Criteria

Inclusion Criteria:

Patients with histologically proven intracranial glioblastoma or gliosarcoma will be eligible for this protocol
Patients with recurrent glioblastoma or gliosarcoma who are scheduled to start systemic chemotherapy with bevacizumab.
Patients tumor must be located in an area that is amenable to the proposed imaging sequences.
Patients must be age 18 or older.
Karnofsky Performance Status Scale (KPS) >/= 70.
Inclusion of Women and Minorities: Both men and women and members of all races and ethnic groups are eligible for this trial.
Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policies of the hospital. The only acceptable consent form is the one attached at the end of this protocol.

Exclusion Criteria:

Patients with histologically proven intracranial glioblastoma or gliosarcoma will be eligible for this protocol
Patients with recurrent glioblastoma or gliosarcoma who are scheduled to start systemic chemotherapy with bevacizumab.
Patients tumor must be located in an area that is amenable to the proposed imaging sequences.
Patients must be age 18 or older.
KPS >/= 70.
Inclusion of Women and Minorities: Both men and women and members of all races and ethnic groups are eligible for this trial.
Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policies of the hospital.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777686

Locations

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

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Principal Investigator:	John DeGroot, MD	UT MD Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

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Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00777686
Other Study ID Numbers:	2007-0492
First Posted:	October 22, 2008 Key Record Dates
Last Update Posted:	March 30, 2012
Last Verified:	March 2012

Keywords provided by M.D. Anderson Cancer Center:


Intracranial Glioblastoma Intracranial Gliosarcoma glioblastoma recurrent glioblastoma gliosarcoma brain cancer magnetic resonance spectroscopy MRS magnetic resonance imaging	MRI MRI/MRS Recurrent Glioblastoma Treated with Antiangiogenic agents contrast enhanced MRI DCE-MRI diffusion-weighted MRI DSC DW-MRI

Additional relevant MeSH terms:

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Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors	Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue

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