Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005082
Status:
COMPLETED
Last Update Posted:
2013-01-08
First Post:
2000-04-06
Brief Title:
Magnetic Resonance Imaging in Determining Extent of Cancer in Patients With Newly Diagnosed Glioma
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Magnetic Resonance Correlates of Glioma Tumor Burden
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
PURPOSE Diagnostic study of magnetic resonance imaging to determining the extent of cancer in patients who have newly diagnosed glioma
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1725 | None | None | None |
| UCLA-9808001 | None | None | None |