GlioblastomaNCT01604590
Imaging Biomarkers of Tissue Microstructure and Vasculature as Predictors of Glioblastoma Multiforme
An observational study of Glioblastoma, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Magnetic Resonance Imaging (MRI)
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Sep 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female subjects, 18-80 years old with progressive glioblastoma who receive bevacizumab
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Imaging Biomarkers of Tissue Microstructure and Vasculature as Predictors of Glioblastoma Multiforme Response to Treatment With Bevacizumab for Progressive Disease
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.
Read the 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.
- Conditions
- Glioblastoma
- Being tested
- Magnetic Resonance Imaging (MRI)
- Keywords
- Glioblastoma, Imaging Biomarkers, Bevacizumab, MRI
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Radiation
Magnetic Resonance Imaging (MRI) will be used to compare bevacizumab to the images of vessel and tumor structure.
| Study group | Role | What they receive |
|---|---|---|
| glioblastoma patients on bevacizumab | Not described Receives: Radiation: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI to show differences between bevacizumab responses
The MRI parameters will help show the differences between bevacizumab-responsive and bevacizumab non-responsive recurrent glioblastoma
Measured: 1 month
Secondary outcomes (1)
Progression Free Survival at 3 months
The progression of the subject's disease will be evaluated at 3 months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Giglio, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604590
- Sponsor's protocol ID
- 101652, MUSC
- Status last verified
- Mar 2015
- First submitted
- 21 May 2012
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Biomarkers of Tissue Microstructure and Vasculature as Predictors of Glioblastoma Multiforme Response to Treatment With Bevacizumab for Progressive Disease
- ClinicalTrials.gov ID
- NCT01604590
- Acronym / sponsor ID
- 101652, MUSC
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, Imaging Biomarkers, Bevacizumab, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 23 May 2012 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| glioblastoma patients on bevacizumab | – | Radiation: Magnetic Resonance Imaging (MRI) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects, 18-80 years old with progressive glioblastoma who receive bevacizumab
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- Contraindication to MRI
- Contraindication to bevacizumab therapy
- Concurrent enrollment in other neuroimaging trials
- Prior therapy with bevacizumab
- Known hypersensitivity to MRI contrast
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 |
|---|---|---|
| Magnetic Resonance Imaging (MRI)Magnetic Resonance Imaging (MRI) will be used to compare bevacizumab to the images of vessel and tumor structure. | Radiation | glioblastoma patients on bevacizumab |
Primary outcome
MRI to show differences between bevacizumab responses
Time frame: 1 month
The MRI parameters will help show the differences between bevacizumab-responsive and bevacizumab non-responsive recurrent glioblastoma
1 secondary outcome
Progression Free Survival at 3 months
Time frame: 3 months
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 13 Apr 2015.
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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.
Pierre Giglio, MD principal investigator
Medical University of South Carolina
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 Glioblastoma, run by Medical University of South Carolina 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 6 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 13 Apr 2015. 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?
MRI to show differences between bevacizumab responses (time frame: 1 month). 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 13 Apr 2015.