NCT00005082

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1998

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2000

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2000

Completed
3.5 years until next milestone

First Posted

Study publicly available on registry

April 23, 2004

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

Enrollment Period

2 years

First QC Date

April 6, 2000

Last Update Submit

January 7, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

adult medulloblastomaadult glioblastomaadult anaplastic astrocytomaadult myxopapillary ependymomaadult anaplastic ependymomaadult anaplastic oligodendrogliomaadult mixed gliomaadult pilocytic astrocytomaadult subependymomaadult ependymoblastomaadult oligodendrogliomaadult giant cell glioblastomaadult gliosarcoma

Interventions

biopsyPROCEDURE
magnetic resonance imagingPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsMedulloblastomaGlioblastomaAstrocytomaEpendymomaOligodendrogliomaGliomaGlioma, SubependymalNeuroectodermal Tumors, PrimitiveGliosarcoma

Interventions

BiopsyMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative TechniquesSpectrum AnalysisChemistry Techniques, Analytical

Study Officials

  • Jeffry Alger, PhD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 6, 2000

First Posted

April 23, 2004

Study Start

November 1, 1998

Primary Completion

November 1, 2000

Last Updated

January 8, 2013

Record last verified: 2013-01

Locations

US(1)