Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Evaluating Patients Who Are Undergoing Treatment for Gliomas
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of California, San Francisco
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00274755
First received: January 10, 2006
Last updated: February 6, 2009
Last verified: April 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: chemotherapy Procedure: conventional surgery Procedure: magnetic resonance imaging Procedure: magnetic resonance spectroscopic imaging Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Improved Characterization of Brain Tumors By MRI and MRS |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Survival [ Designated as safety issue: No ]
- Time to clinical progression [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | November 2003 |
| Estimated Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the magnetic resonance spectroscopic imaging (MRSI) characteristics of patients who are undergoing treatment for supratentorial glioma.
- Determine the survival of patients who undergo magnetic resonance imaging and MRSI.
- Determine the clinical outcome of patients who undergo these imaging procedures.
- Correlate measures of metabolic tumor burden (i.e., CNI, CCCrI, CrNI, and LLI) with survival and clinical outcome in patients who undergo these imaging procedures.
- Determine the time to clinical progression in patients who undergo these imaging procedures.
OUTLINE: Patients are assigned to 1 of 2 treatment groups based on grade of disease.
- Group 1 (patients with grade II glioma): Patients undergo magnetic resonance imaging (MRI) and magnetic resonance spectroscopic imaging (MRSI). Patients then receive chemotherapy. Patients undergo repeat MRI/MRSI after courses 2 and 4 of chemotherapy.
- Group 2 (patients with grade III-IV glioma): Patients undergo MRI/MRSI and then undergo surgical resection of the tumor. Patients then receive chemoradiotherapy. Patients undergo repeat MRI/MRSI within 2 weeks and at 2 months after completion of radiotherapy.
Patients are followed for recurrence, disease progression, and survival.
PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274755
Locations
| United States, California | |
| UCSF Helen Diller Family Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
Sponsors and Collaborators
University of California, San Francisco
Investigators
| Principal Investigator: | Sarah J. Nelson, PhD | University of California, San Francisco |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00274755 History of Changes |
| Other Study ID Numbers: | CDR0000441015, UCSF-05106 |
| Study First Received: | January 10, 2006 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adult anaplastic astrocytoma adult diffuse astrocytoma adult glioblastoma adult giant cell glioblastoma adult gliosarcoma adult pilocytic astrocytoma adult anaplastic ependymoma |
adult ependymoma adult myxopapillary ependymoma adult subependymoma adult anaplastic oligodendroglioma adult oligodendroglioma adult mixed glioma |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms by Site Neoplasms Nervous System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013