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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

Improved Characterization of Brain Tumors By MRI and MRS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00274755
• Other study ID #: CDR0000441015
• Secondary ID: UCSF-05106
• Status: Completed
• Phase: Phase 2
• First received: January 10, 2006
• Last updated: May 19, 2014
• Start date: November 2003

Study information

• Verified date: May 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• chemotherapy

Procedure:
• conventional surgery

• magnetic resonance imaging

• magnetic resonance spectroscopic imaging

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival			No
Primary	Time to clinical progression			No