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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
chemotherapy
conventional surgery
magnetic resonance imaging
magnetic resonance spectroscopic imaging
radiation therapy
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain and Central Nervous System Tumors focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Survival
Time to clinical progression

Secondary Outcome Measures

Full Information

First Posted
January 10, 2006
Last Updated
May 19, 2014
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00274755
Brief Title
Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Evaluating Patients Who Are Undergoing Treatment for Gliomas
Official Title
Improved Characterization of Brain Tumors By MRI and MRS
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
chemotherapy
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance spectroscopic imaging
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Survival
Title
Time to clinical progression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah J. Nelson, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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