Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Evaluating Patients Who Are Undergoing Treatment for Gliomas

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT00274755

Collaborator

National Cancer Institute (NCI) (NIH)

250

Enrollment

Location

Study Details

Study Description

Brief Summary

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

Detailed Description

OBJECTIVES:

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 Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Improved Characterization of Brain Tumors By MRI and MRS

Study Start Date :

Nov 1, 2003

Actual Primary Completion Date :

Apr 1, 2007

Outcome Measures

Primary Outcome Measures

Survival []
Time to clinical progression []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed supratentorial glioma
Grade II-IV disease
Previously untreated disease
Eligible for surgical resection and/or chemotherapy with or without radiotherapy
Tumor accessible by magnetic resonance spectroscopic imaging

PATIENT CHARACTERISTICS:

Karnofsky performance status 60-100%
Life expectancy ≥ 8 weeks
Not pregnant
No contraindication for magnetic resonance examinations, including any of the following:
Cardiac pacemaker or fibrillator
Aneurysm clip
Insulin or infusion pump
Any implant held in place by a magnet
Metal contamination anywhere in the body