NCT00274755

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Last Updated

May 20, 2014

Status Verified

May 1, 2014

Enrollment Period

3.4 years

First QC Date

January 10, 2006

Last Update Submit

May 19, 2014

Conditions

Brain and Central Nervous System Tumors

Keywords

adult anaplastic astrocytomaadult diffuse astrocytomaadult glioblastomaadult giant cell glioblastomaadult gliosarcomaadult pilocytic astrocytomaadult anaplastic ependymomaadult ependymomaadult myxopapillary ependymomaadult subependymomaadult anaplastic oligodendrogliomaadult oligodendrogliomaadult mixed glioma

Outcome Measures

Primary Outcomes (2)

  • Survival

  • Time to clinical progression

Interventions

chemotherapyDRUG
conventional surgeryPROCEDURE
magnetic resonance imagingPROCEDURE
magnetic resonance spectroscopic imagingPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

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

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

Sponsors & Collaborators

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsAstrocytomaGlioblastomaGliosarcomaEpendymomaGlioma, SubependymalOligodendrogliomaGlioma

Interventions

Drug TherapyMagnetic Resonance SpectroscopyRadiotherapy

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)

TherapeuticsSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Sarah J. Nelson, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 11, 2006

Study Start

November 1, 2003

Primary Completion

April 1, 2007

Last Updated

May 20, 2014

Record last verified: 2014-05

Locations

US(1)