Magnetic
Resonance Imaging in Determining Extent of Cancer in Patients With Newly Diagnosed Glioma
This study
is currently recruiting patients.
Sponsored by
National Cancer Institute
(NCI)
Jonsson Comprehensive Cancer
Center
Purpose
RATIONALE: New imaging procedures, such as
proton magnetic resonance spectroscopic imaging and diffusion magnetic resonance imaging,
may improve the ability to detect the extent of newly diagnosed cancer. PURPOSE:
Diagnostic study of magnetic resonance imaging in determining the extent of cancer in
patients who have newly diagnosed glioma.
Condition
|
Treatment
or Intervention |
adult
medulloblastoma adult glioblastoma multiforme adult anaplastic astrocytoma mixed gliomas adult well-differentiated ependymoma adult juvenile pilocytic astrocytoma adult subependymal astrocytoma adult well-differentiated mildly and moderately anaplastic
astrocytoma adult malignant ependymoma adult anaplastic oligodendroglioma adult ependymoblastoma adult well-differentiated oligodendroglioma |
Drug: dexamethasone
|
Study Type: Diagnostic
Official Title: Diagnostic Study of Magnetic Resonance Imaging
Correlates of Tumor Cell Burden in Patients With Gliomas
Further Study Details: OBJECTIVES: I. Determine whether proton
magnetic resonance spectroscopic imaging (1H-MRSI) and diffusion magnetic resonance
imaging (DI) measures of glioma cell burden correlate with histopathologically measured
cell counts in glioma patients who are scheduled to undergo surgical resection. II.
Determine whether 1H-MRSI and DI measures of glioma cell burden are invariant over the
short term (1 week) as steroid dose is increased in these patients. PROTOCOL
OUTLINE: Part I: Patients who are scheduled to have surgical resection of brain tumor
undergo conventional magnetic resonance imaging (MRI), proton magnetic resonance
spectroscopic imaging (1H-MRSI), and diffusion magnetic resonance imaging (DI) within 1
week before resection. Patients undergo conventional MRI within 72 hours after completion
of surgical resection. Image characteristics of the resected tissue are correlated with
histopathological measures. Part II: Patients who have clinical indications for increasing
the dexamethasone dose are treated on part II of the study. Patients are stratified by
status of steroid treatment (steroid naive vs prior steroid management). Patients undergo
conventional MRI, 1H-MRSI, and DI within 2 days before and within 4-7 days after
increasing the dexamethasone dose. Image characteristics on films taken before and after
increasing the dexamethasone dose are compared. PROJECTED ACCRUAL: A total of 75
patients will be accrued for part I of the study and a total 40 patients (20 per stratum)
will be accrued for part II of the study within 4 years.
Eligibility
Ages Eligible for Study: 16 Years
and above Criteria
PROTOCOL ENTRY CRITERIA: --Disease
Characteristics-- Part I: Presurgical: presumptive diagnosis of intracranial glioma and
scheduled to undergo first surgical resection OR stereotactic biopsy Postsurgical:
Histologically proven intracranial glioma and scheduled to undergo surgical debulking
Evaluable preoperative proton magnetic resonance spectroscopic imaging (1H-MRSI) and
diffusion magnetic resonance imaging (DI) scans completed within 1 week prior to surgery
Postoperative MRI, 1H-MRSI, and DI scans completed within 3 days after surgery Part II:
Presurgical: presumptive diagnosis of intracranial glioma Postsurgical: Histologically
proven intracranial glioma No surgery prior to completion of exit scans Clinical
indication for increasing steroid dose Planned steroid changes must be from 0 to 16 mg/day
or a twofold increase Evaluable 1H-MRSI and DI scans No prior treatment on this protocol
Parts I and II: No contraindications for magnetic resonance imaging (MRI) (metallic
implants, shrapnel fragments, claustrophobia, allergy to MRI contrast) --Prior/Concurrent
Therapy-- Biologic therapy: Parts I and II: Not specified Chemotherapy: Parts I and II:
Not specified Endocrine therapy: Part I: Not specified Part II: Steroid naive or prior
steroid management allowed Radiotherapy: Parts I and II: See Disease Characteristics
Surgery: Part I: See Disease Characteristics No information from more than 2 surgeries
from any one patient Part II: See Disease Characteristics --Patient Characteristics-- Age:
Parts I and II: Over 16 Performance status: Parts I and II: Not specified Life expectancy:
Parts I and II: Not specified Hematopoietic: Parts I and II: Not specified Hepatic: Parts
I and II: Not specified Renal: Parts I and II: Not specified
Location and Contact Information
California
Jonsson Comprehensive Cancer Center,
UCLA, Los Angeles, California, 90095-1781, United
States; Recruiting
Timothy F. Cloughesy
310-794-7542
Study chairs or principal investigators
Jeffry Alger, Study Chair
Jonsson Comprehensive Cancer Center
More Information
Study ID Numbers 199/14871;
UCLA-9808001; NCI-G00-1725
NLM Identifier NCT00005082
Date study started November 3, 1998
Last Updated April 1, 2000