MRI Scans in Evaluating the Effects of Radiation Therapy and Chemotherapy in Patients With Newly Diagnosed Glioblastoma Multiforme



Status:Archived
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:July 2008

Use our guide to learn which trials are right for you!

Quantitative Assessment of the Early and Late Effects of Radiation and Chemotherapy on Glioblastoma Using Multiple MRI Techniques


RATIONALE: Diagnostic procedures, such as MRI, may help in learning how well radiation
therapy and chemotherapy work in killing tumor cells and allow doctors to plan better
treatment.

PURPOSE: This clinical trial is studying MRI scans to see how well they evaluate the effects
of radiation therapy and chemotherapy in patients with newly diagnosed glioblastoma
multiforme.


OBJECTIVES:

Primary

- To quantitatively compare the relative cerebral blood volume/flow, mean transit time,
and mean vessel diameter as measured by perfusion-weighted MRI before, during, and
after chemoradiotherapy in patients with newly diagnosed glioblastoma multiforme.

- To measure the permeability-surface area product on a voxel-by-voxel basis before,
during, and after chemoradiotherapy in these patients.

- To measure the full water self-diffusion tensor on a voxel-by-voxel basis before,
during, and after chemoradiotherapy in these patients.

- To compare the tensor fractional anisotropy before, during, and after chemoradiotherapy
in these patients.

- To compare the relative regional concentrations of choline, N-acetyl-asparate, and
myoinositol as measured by magnetic resonance spectroscopy before, during, and after
chemoradiotherapy to interrogate cell membrane turnover, neuronal integrity, and glial
reactions.

- To test the affects of a short period of 100% oxygen inhalation on imaging of tumor and
surrounding tissue regions of interest, specifically cerebral blood volume changes in
each area as compared to room air.

Secondary

- To collect blood and urine samples for correlation analysis between imaging changes,
molecular markers (including genetic markers), and clinical outcome of glioblastoma
multiforme (phenotypic information).

- To correlate blood and urine biomarkers and blood genetic markers with tumor expression
of these markers.

OUTLINE: Patients undergo radiotherapy once daily 5 days a week for 6 weeks. Patients also
receive oral temozolomide once daily 7 days a week during radiotherapy. After completion of
chemoradiotherapy, patients receive oral temozolomide once daily for 5 days. Treatment with
temozolomide repeats every 28 days in the absence of disease progression or unacceptable
toxicity.

Patients undergo MRI, including perfusion- and diffusion-weighted MRI, diffusion tensor
imaging, and magnetic resonance spectroscopy prior to initiation of chemoradiotherapy, once
weekly during chemoradiotherapy, and then monthly until tumor progression or until
completion of 6 courses of post chemoradiotherapy.

After completion of study treatment, patients are followed annually.


We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials