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Measuring Non-Enhancing Glioblastoma Progression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00777686
Recruitment Status : Completed
First Posted : October 22, 2008
Last Update Posted : March 30, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment
Brain Tumor Glioblastoma Procedure: MRI/MRS Scan

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quantifying Progression of Non-Enhancing Tumor in Patients With Recurrent Glioblastoma Treated With Antiangiogenic Agents
Study Start Date : August 2008
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
MRI/MRS Scanning
Magnetic resonance imaging with magnetic resonance spectroscopy (MRI/MRS Scanning)
Procedure: MRI/MRS Scan
MRI/MRS brain scan with intravenous contrast prior to chemotherapy, then repeated every 8 weeks.
Other Names:
  • magnetic resonance spectroscopy
  • MR Imaging
  • MR
  • MRI/MRS scanning
  • MRI/MRS
  • MRI
  • MRS


Outcome Measures

Primary Outcome Measures :
  1. Functional MR Measurements [ Time Frame: Baseline, Every 8 weeks and at Off Study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients, 18 years or older, with "recurrent" intracranial glioblastoma or gliosarcoma being treated with chemotherapy or will be treated.
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777686


Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: John DeGroot, MD UT MD Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00777686     History of Changes
Other Study ID Numbers: 2007-0492
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: March 30, 2012
Last Verified: March 2012

Keywords provided by M.D. Anderson Cancer Center:
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

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
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents