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Magnetic Resonance Imaging in Determining Extent of Cancer in Patients With Newly Diagnosed Glioma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
biopsy
magnetic resonance imaging
Sponsored by
Jonsson Comprehensive Cancer Center
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 medulloblastoma, adult glioblastoma, adult anaplastic astrocytoma, adult myxopapillary ependymoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult pilocytic astrocytoma, adult subependymoma, adult ependymoblastoma, adult oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

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

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) PATIENT CHARACTERISTICS: Age: Parts I and II: Over 18 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 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

Sites / Locations

  • Jonsson Comprehensive Cancer Center, UCLA

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 6, 2000
Last Updated
January 7, 2013
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005082
Brief Title
Magnetic Resonance Imaging in Determining Extent of Cancer in Patients With Newly Diagnosed Glioma
Official Title
Magnetic Resonance Correlates of Glioma Tumor Burden
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 1998 (undefined)
Primary Completion Date
November 2000 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: New imaging procedures such as magnetic resonance imaging may improve the ability to detect the extent of newly diagnosed cancer. PURPOSE: Diagnostic study of magnetic resonance imaging to determining the extent of cancer in patients who have newly diagnosed glioma.
Detailed Description
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. 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.

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 medulloblastoma, adult glioblastoma, adult anaplastic astrocytoma, adult myxopapillary ependymoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult pilocytic astrocytoma, adult subependymoma, adult ependymoblastoma, adult oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
biopsy
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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) PATIENT CHARACTERISTICS: Age: Parts I and II: Over 18 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffry Alger, PhD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

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Magnetic Resonance Imaging in Determining Extent of Cancer in Patients With Newly Diagnosed Glioma

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