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| Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005082 |
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: | Diagnostic |
| Official Title: | Magnetic Resonance Correlates of Glioma Tumor Burden |
| Study Start Date: | November 1998 |
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 |
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| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Study Chair: | Jeffry Alger, PhD | Jonsson Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000067691, UCLA-9808001, NCI-G00-1725 |
| Study First Received: | April 6, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00005082 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Glioblastoma Astrocytoma Central Nervous System Neoplasms Ependymoma Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Medulloblastoma |
Neuroepithelioma Oligodendroglioma Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
|
Neuroectodermal Tumors Neoplasms Neoplasms by Site Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Nervous System Diseases |
Neoplasms, Nerve Tissue Central Nervous System Neoplasms Glioma Neoplasms, Neuroepithelial Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
