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

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 2

Conditions: Brain and Central Nervous System Tumors

Treatments: Radiation: radiation therapy; Drug: chemotherapy; Procedure: conventional surgery; Procedure: magnetic resonance spectroscopic imaging; Procedure: magnetic resonance imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00274755

UCSF-05106

CDR0000441015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy
• No prior radiotherapy
• No prior treatment for the malignancy