Brain TumorNCT00777686
Measuring Non-Enhancing Glioblastoma Progression
An observational study of Brain Tumor and Glioblastoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Glioblastoma
- What is being tested?
- MRI/MRS Scan
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients, 18 years or older, with "recurrent" intracranial glioblastoma or gliosarcoma being treated with chemotherapy or will be treated.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantifying Progression of Non-Enhancing Tumor in Patients With Recurrent Glioblastoma Treated With Antiangiogenic Agents
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.
Read the 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.
- Conditions
- Brain Tumor, Glioblastoma
- Being tested
- MRI/MRS Scan
- Keywords
- 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
- Medical subject headings
- Brain Neoplasms, Glioblastoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI/MRS ScanProcedure or surgery
Also called magnetic resonance spectroscopy, MR Imaging, MR, MRI/MRS scanning
MRI/MRS brain scan with intravenous contrast prior to chemotherapy, then repeated every 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| MRI/MRS Scanning | Magnetic resonance imaging with magnetic resonance spectroscopy (MRI/MRS Scanning) Receives: Procedure: MRI/MRS Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional MR Measurements
Measured: Baseline, Every 8 weeks and at Off Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startAug 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John DeGroot, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777686
- Sponsor's protocol ID
- 2007-0492
- Status last verified
- Mar 2012
- First submitted
- 20 Oct 2008
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Progression of Non-Enhancing Tumor in Patients With Recurrent Glioblastoma Treated With Antiangiogenic Agents
- ClinicalTrials.gov ID
- NCT00777686
- Acronym / sponsor ID
- 2007-0492
- Conditions
- Brain Tumor, Glioblastoma
- Keywords
- Intracranial Glioblastoma, Intracranial Gliosarcoma, glioblastoma, recurrent glioblastoma, gliosarcoma, brain cancer, magnetic resonance spectroscopy, MRS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 22 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI/MRS Scanning | – | Procedure: MRI/MRS ScanMagnetic resonance imaging with magnetic resonance spectroscopy (MRI/MRS Scanning) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, 18 years or older, with "recurrent" intracranial glioblastoma or gliosarcoma being treated with chemotherapy or will be treated.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI/MRS ScanAlso: magnetic resonance spectroscopy, MR Imaging, MR, MRI/MRS scanningMRI/MRS brain scan with intravenous contrast prior to chemotherapy, then repeated every 8 weeks. | Procedure or surgery | MRI/MRS Scanning |
Primary outcome
Functional MR Measurements
Time frame: Baseline, Every 8 weeks and at Off Study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
- MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John DeGroot, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor and Glioblastoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional MR Measurements (time frame: Baseline, Every 8 weeks and at Off Study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2012.