Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274755
Status:
COMPLETED
Last Update Posted:
2014-05-20
First Post:
2006-01-10
Brief Title:
Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Evaluating Patients Who Are Undergoing Treatment for Gliomas
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Improved Characterization of Brain Tumors By MRI and MRS
Status:
COMPLETED
Status Verified Date:
2014-05
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 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 patients 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
PURPOSE This phase II trial is studying how well MRI and MRSI evaluate patients who are undergoing treatment for gliomas
Detailed Description:
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 ie 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 MRIMRSI after courses 2 and 4 of chemotherapy
Group 2 patients with grade III-IV glioma Patients undergo MRIMRSI and then undergo surgical resection of the tumor Patients then receive chemoradiotherapy Patients undergo repeat MRIMRSI 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
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 ie 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 MRIMRSI after courses 2 and 4 of chemotherapy
Group 2 patients with grade III-IV glioma Patients undergo MRIMRSI and then undergo surgical resection of the tumor Patients then receive chemoradiotherapy Patients undergo repeat MRIMRSI 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCSF-05106 | None | None | None |