Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Diagnostic, Treatment Closed Over 18 NCI UCSF-05106 NCT00274755

Special Category: SPORE trial

Objectives

1. Determine the magnetic resonance spectroscopic imaging (MRSI) characteristics of patients who are undergoing treatment for supratentorial glioma.
2. Determine the survival of patients who undergo magnetic resonance imaging and MRSI.
3. Determine the clinical outcome of patients who undergo these imaging procedures.
4. 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.
5. Determine the time to clinical progression in patients who undergo these imaging procedures.

Entry 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

Prior/Concurrent Therapy:

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

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

Expected Enrollment

A total of 250 patients will be accrued for this study.

Outcomes

Survival
Time to clinical progression

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.

Trial Contact Information

Trial Lead Organizations

UCSF Helen Diller Family Comprehensive Cancer Center

Sarah Nelson, PhD, Principal investigator		Ph: 415-476-6383; 800-888-8664 Email: sarah.nelson@radiology.ucsf.edu

Registry Information
Official Title		Improved Characterization of Brain Tumors By MRI and MRS
Trial Start Date		2003-11-20
Trial Completion Date		2007-04-30 (estimated)
Registered in ClinicalTrials.gov		NCT00274755
Date Submitted to PDQ		2005-07-14
Information Last Verified		2007-04-06
NCI Grant/Contract Number		CA82103, CA58223

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