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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00005082
First received: April 6, 2000
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Brain and Central Nervous System Tumors
Procedure: biopsy
Procedure: magnetic resonance imaging

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Correlates of Glioma Tumor Burden

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Enrollment: 1
Study Start Date: November 1998
Primary Completion Date: November 2000 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005082

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Jeffry Alger, PhD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00005082     History of Changes
Other Study ID Numbers: CDR0000067691, UCLA-9808001, NCI-G00-1725
Study First Received: April 6, 2000
Last Updated: January 7, 2013
Health Authority: United States: Federal Government

Keywords provided by Jonsson Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Glioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on April 22, 2014