Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005083
Status:
WITHDRAWN
Last Update Posted:
2012-10-04
First Post:
2000-04-06
Brief Title:
Functional Magnetic Resonance Imaging and 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Treating Patients With Newly Diagnosed Brain Tumors
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Defining Functional Tissue in Brain Tumors With Integrated Neuroimaging Pilot Study
Status:
WITHDRAWN
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no participants enrolled
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 functional magnetic resonance imaging and 1H-nuclear magnetic resonance spectroscopic imaging may improve the ability to detect the extent of cancer in the brain
PURPOSE Phase II trial to study the effectiveness of functional magnetic resonance imaging and 1H-nuclear magnetic resonance spectroscopic imaging in treating patients who have newly diagnosed brain tumors
PURPOSE Phase II trial to study the effectiveness of functional magnetic resonance imaging and 1H-nuclear magnetic resonance spectroscopic imaging in treating patients who have newly diagnosed brain tumors
Detailed Description:
OBJECTIVES I Determine the definable topospecific relationship between functional neuroactivation measured by functional magnetic resonance imaging fMRI and chemostructural tissue measurements made with 1H-nuclear magnetic resonance spectroscopic imaging 1H-NMRSI in patients with newly diagnosed brain tumors situated in the vicinity of the brains language and motor regions II Determine if clinical improvement correlates with stronger imaging signatures of neuroactivation on fMRI in this patient population III Determine if functional loss during tumor recurrence or progression correlates with increases in choline and decreases in N-acetylaspartate on 1H-NMRSI in regions that previously displayed activation on fMRI or in associated underlying white matter regions in these patients
OUTLINE Patients undergo preoperative functional magnetic resonance imaging fMRI 1H-nuclear magnetic resonance spectroscopic imaging 1H-NMRSI and conventional contrast MRI over 2 hours followed by neurofunctional motor andor language neurofunctional testing Intraoperatively patients undergo corticography consisting of awake language mapping and motor cortex stimulation Patients undergo repeat imaging and neurofunctional evaluation at 2 weeks following surgery and prior to any radiotherapy or chemotherapy Patients also undergo neurological and neuropsychological testing consisting of basic gait motor coordination reflexes hand motor tongue motor and language evaluation to measure baseline preoperative and postoperative clinical status and outcomes Patients are followed every 4 months for 1 year
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study over 4 years
OUTLINE Patients undergo preoperative functional magnetic resonance imaging fMRI 1H-nuclear magnetic resonance spectroscopic imaging 1H-NMRSI and conventional contrast MRI over 2 hours followed by neurofunctional motor andor language neurofunctional testing Intraoperatively patients undergo corticography consisting of awake language mapping and motor cortex stimulation Patients undergo repeat imaging and neurofunctional evaluation at 2 weeks following surgery and prior to any radiotherapy or chemotherapy Patients also undergo neurological and neuropsychological testing consisting of basic gait motor coordination reflexes hand motor tongue motor and language evaluation to measure baseline preoperative and postoperative clinical status and outcomes Patients are followed every 4 months for 1 year
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study over 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-G00-1726 | None | None | None |
| UCLA-9712069 | None | None | None |