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OpenTrials
Completed

NCT Number: NCT00274755

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy

Drug

conventional surgery

Procedure

Magnetic Resonance Imaging

Procedure

magnetic resonance spectroscopic imaging

Procedure

radiation therapy

Radiation

Primary outcomes

  1. Survival

  2. Time to clinical progression

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Improved Characterization of Brain Tumors By MRI and MRS

Important dates

Study start
2003
Primary completion
2007
First posted
Jan 11, 2006
Registry last updated
May 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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