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

Improved Characterization of Brain Tumors By MRI and MRS

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00274755
Enrollment
250
Registered
2006-01-11
Start date
2003-11-30
Completion date
Unknown
Last updated
2014-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGchemotherapy
PROCEDUREconventional surgery
PROCEDUREmagnetic resonance imaging
PROCEDUREmagnetic resonance spectroscopic imaging
RADIATIONradiation therapy

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of California, San Francisco
Lead SponsorOTHER

Study design

Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Survival
Time to clinical progression

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026