Imaging Biomarkers of Tissue Microstructure and Vasculature as Predictors of Glioblastoma Multiforme
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Glioblastoma |
Radiation: Magnetic Resonance Imaging (MRI) |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Imaging Biomarkers of Tissue Microstructure and Vasculature as Predictors of Glioblastoma Multiforme Response to Treatment With Bevacizumab for Progressive Disease |
- MRI to show differences between bevacizumab responses [ Time Frame: 1 month ] [ Designated as safety issue: No ]The MRI parameters will help show the differences between bevacizumab-resposive and bevacizumab non-responsive recurrent glioblastoma
- Progression Free Survival at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]The progression of the subject's disease will be evaluated at 3 months.
| Estimated Enrollment: | 20 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| glioblastoma patients on bevacizumab |
Radiation: Magnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging (MRI) will be used to compare bevacizumab to the images of vessel and tumor structure.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Male and female subjects, 18-80 years old with progressive glioblastoma who receive bevacizumab
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 Stupp regimen
- 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
Contacts and Locations| Contact: John Keller | 843-792-1286 | kellej@musc.edu |
| Contact: Pierre Giglio, MD | 843-792-6592 | giglio@musc.edu |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: John Keller 843-792-1286 kellej@musc.edu | |
| Contact: Pierre Giglio, MD 843-792-6592 giglio@musc.edu | |
| Principal Investigator: Pierre Giglio, MD | |
| Sub-Investigator: Mark A Ahlman, MD | |
| Sub-Investigator: Zoran Rumboldt, MD | |
| Sub-Investigator: Vittoria Spampinato, MD | |
| Sub-Investigator: Ali Tabesh, PhD | |
| Sub-Investigator: Sai K Hui, PhD | |
| Sub-Investigator: Leonardo Bonilha, MD | |
| Sub-Investigator: Joan Cunningham, PhD | |
| Sub-Investigator: Truman Brown, PhD | |
| Sub-Investigator: Jens Jensen, PhD | |
| Sub-Investigator: Joseph Helpern, PhD | |
| Principal Investigator: | Pierre Giglio, MD | Medical University of South Carolina |
More Information
No publications provided
| Responsible Party: | Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT01604590 History of Changes |
| Other Study ID Numbers: | 101652, MUSC |
| Study First Received: | May 21, 2012 |
| Last Updated: | June 17, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Medical University of South Carolina:
|
Glioblastoma Imaging Biomarkers Bevacizumab MRI |
Additional relevant MeSH terms:
|
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013