Imaging Biomarkers of Tissue Microstructure and Vasculature as Predictors of Glioblastoma Multiforme

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01604590
First received: May 21, 2012
Last updated: July 31, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 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-responsive and bevacizumab non-responsive recurrent glioblastoma


Secondary Outcome Measures:
  • 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: July 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 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
Study Population

Male and female subjects, 18-80 years old with progressive glioblastoma who receive bevacizumab

Criteria

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 radiation and chemotherapy
  • 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
  • Females who are nursing or pregnant
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604590

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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: July 31, 2014
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 September 29, 2014