Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Evaluating Patients Who Are Undergoing Treatment for Gliomas
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|ClinicalTrials.gov Identifier: NCT00274755|
Recruitment Status : Completed
First Posted : January 11, 2006
Last Update Posted : May 20, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: chemotherapy Procedure: conventional surgery Procedure: magnetic resonance imaging Procedure: magnetic resonance spectroscopic imaging Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Masking:||None (Open Label)|
|Official Title:||Improved Characterization of Brain Tumors By MRI and MRS|
|Study Start Date :||November 2003|
|Actual Primary Completion Date :||April 2007|
- Time to clinical progression
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): 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|