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CompletedNCT00274755Updated May 20, 2014

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

A Phase 2 interventional study of chemotherapy and conventional surgery in Brain and Central Nervous System Tumors, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-20.

Sponsored by University of California, San Francisco · Phase 2, Interventional, and Diagnostic

Phase
Phase 2
Study type
Interventional
Enrollment
250
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Brain and Central Nervous System Tumors

Keywords

  • adult anaplastic astrocytoma
  • adult diffuse astrocytoma
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult pilocytic astrocytoma
  • adult anaplastic ependymoma
  • adult ependymoma
  • adult myxopapillary ependymoma
  • adult subependymoma
  • adult anaplastic oligodendroglioma
  • adult oligodendroglioma
  • adult mixed glioma
03

In context

Nervous System Neoplasms

538 studies on the registry are indexed under Nervous System Neoplasms; 14 are open to participants now.

This study's planned enrollment of 250 is above the median of 35 across 379 interventional studies indexed under Nervous System Neoplasms.

Browse Nervous System Neoplasms studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Masking
None (open label)
Enrollment
250 participants (estimated)

Interventions

  • Drugchemotherapy
  • Procedureconventional surgery
  • Proceduremagnetic resonance imaging
  • Proceduremagnetic resonance spectroscopic imaging
  • Radiationradiation therapy
06

What researchers measure

Primary outcomes

  1. Survival

  2. Time to clinical progression

07

Study locations

1 site
  • UCSF Helen Diller Family Comprehensive Cancer Center
    San Francisco, California 94115, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00274755
Lead sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
First posted
Jan 11, 2006
Start date
Nov 2003
Primary completion
Apr 2007
Last update
May 20, 2014

Study contacts

Sarah J. Nelson, PhD
principal investigator · University of California, San Francisco
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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