NCT00777686

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 30, 2012

Status Verified

March 1, 2012

Enrollment Period

2.6 years

First QC Date

October 20, 2008

Last Update Submit

March 29, 2012

Conditions

Brain TumorGlioblastoma

Keywords

Intracranial GlioblastomaIntracranial Gliosarcomaglioblastomarecurrent glioblastomagliosarcomabrain cancermagnetic resonance spectroscopyMRSmagnetic resonance imagingMRIMRI/MRSRecurrent Glioblastoma Treated with Antiangiogenic agentscontrast enhanced MRIDCE-MRIdiffusion-weighted MRIDSCDW-MRI

Outcome Measures

Primary Outcomes (1)

  • Functional MR Measurements

    Baseline, Every 8 weeks and at Off Study

Study Arms (1)

MRI/MRS Scanning

Magnetic resonance imaging with magnetic resonance spectroscopy (MRI/MRS Scanning)

Procedure: MRI/MRS Scan

Interventions

MRI/MRS ScanPROCEDURE

MRI/MRS brain scan with intravenous contrast prior to chemotherapy, then repeated every 8 weeks.

Also known as: magnetic resonance spectroscopy, MR Imaging, MR, MRI/MRS scanning, MRI/MRS, MRI, MRS
MRI/MRS Scanning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients, 18 years or older, with "recurrent" intracranial glioblastoma or gliosarcoma being treated with chemotherapy or will be treated.

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Brain NeoplasmsGlioblastomaGliosarcoma

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • John DeGroot, MD

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2008

First Posted

October 22, 2008

Study Start

August 1, 2008

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

March 30, 2012

Record last verified: 2012-03

Locations

US(1)