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Measuring Non-Enhancing Glioblastoma Progression

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients with histologically proven intracranial glioblastoma or gliosarcoma will be eligible for this protocol. 2. Patients with recurrent glioblastoma or gliosarcoma who are scheduled to start systemic chemotherapy with bevacizumab. 3. Patients tumor must be located in an area that is amenable to the proposed imaging sequences. 4. Patients must be age 18 or older. 5. Karnofsky Performance Status Scale (KPS) >/= 70. 6. Inclusion of Women and Minorities: Both men and women and members of all races and ethnic groups are eligible for this trial. 7. 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:

1. Patients with histologically proven intracranial glioblastoma or gliosarcoma will be eligible for this protocol. 2. Patients with recurrent glioblastoma or gliosarcoma who are scheduled to start systemic chemotherapy with bevacizumab. 3. Patients tumor must be located in an area that is amenable to the proposed imaging sequences. 4. Patients must be age 18 or older. 5. KPS >/= 70. 6. Inclusion of Women and Minorities: Both men and women and members of all races and ethnic groups are eligible for this trial. 7. 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00777686
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

M.D. Anderson Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

John DeGroot, MD
Principal Investigator Affiliation UT MD Anderson Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Tumor, Glioblastoma
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

: MRI/MRS Scanning

Magnetic resonance imaging with magnetic resonance spectroscopy (MRI/MRS Scanning)

Interventions

Procedure: - MRI/MRS Scan

MRI/MRS brain scan with intravenous contrast prior to chemotherapy, then repeated every 8 weeks.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UT MD Anderson Cancer Center, Houston, Texas

Status

Address

UT MD Anderson Cancer Center

Houston, Texas, 77030