Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Evaluating Patients Who Are Undergoing Treatment for Gliomas
RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI) and magnetic resonance spectroscopic imaging (MRSI), (done before, during, and after treatment) may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This phase II trial is studying how well MRI and MRSI evaluate patients who are undergoing treatment for gliomas.
Brain and Central Nervous System Tumors
Procedure: conventional surgery
Procedure: magnetic resonance imaging
Procedure: magnetic resonance spectroscopic imaging
Radiation: radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Improved Characterization of Brain Tumors By MRI and MRS|
- Survival [ Designated as safety issue: No ]
- Time to clinical progression [ Designated as safety issue: No ]
|Study Start Date:||November 2003|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
- Determine the magnetic resonance spectroscopic imaging (MRSI) characteristics of patients who are undergoing treatment for supratentorial glioma.
- Determine the survival of patients who undergo magnetic resonance imaging and MRSI.
- Determine the clinical outcome of patients who undergo these imaging procedures.
- Correlate measures of metabolic tumor burden (i.e., CNI, CCCrI, CrNI, and LLI) with survival and clinical outcome in patients who undergo these imaging procedures.
- Determine the time to clinical progression in patients who undergo these imaging procedures.
OUTLINE: Patients are assigned to 1 of 2 treatment groups based on grade of disease.
- Group 1 (patients with grade II glioma): Patients undergo magnetic resonance imaging (MRI) and magnetic resonance spectroscopic imaging (MRSI). Patients then receive chemotherapy. Patients undergo repeat MRI/MRSI after courses 2 and 4 of chemotherapy.
- Group 2 (patients with grade III-IV glioma): Patients undergo MRI/MRSI and then undergo surgical resection of the tumor. Patients then receive chemoradiotherapy. Patients undergo repeat MRI/MRSI within 2 weeks and at 2 months after completion of radiotherapy.
Patients are followed for recurrence, disease progression, and survival.
PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274755
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Sarah J. Nelson, PhD||University of California, San Francisco|