Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398437
Status:
UNKNOWN
Last Update Posted:
2013-08-12
First Post:
2006-11-09
Brief Title:
Magnetic Resonance Imaging for the Early Detection of CNS Metastases in Women With Stage IV Breast Cancer
Sponsor:
Jules Bordet Institute
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Role of Gadolinium Enhanced Brain Magnetic Resonance in the Follow Up of Metastatic Breast Cancer Patients Overexpressing HER2 Neu A Randomized Prospective Study
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
RECRUITING
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 may help doctors find CNS metastases and plan treatment
PURPOSE This randomized clinical trial is studying how well MRI finds CNS metastases in women with stage IV breast cancer
PURPOSE This randomized clinical trial is studying how well MRI finds CNS metastases in women with stage IV breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine survival without neurological symptoms due to CNS metastases in women with HER2neu-overexpressing stage IV breast cancer who undergo gadolinium-enhanced magnetic resonance imaging MRI of the brain once every 4 months vs once every 12 months for early detection of CNS metastases
Secondary
Determine the total number of therapeutic procedures ie gamma-knife radiotherapy or surgery required for the treatment of brain metastases in these women
Determine the total number of hospitalization days required in these women
Determine the overall survival of these women
Evaluate a cross-platform manufacturer-independent MRI technique for diagnosis of brain metastases that could be used in future studies in the IRIS and ULB-Canceropôle networks
Compare 2D-SE vs 3D-GE thin sections methods for post-contrast brain imaging in these women
OUTLINE This is a prospective randomized study Patients are randomized to 1 of 2 arms
Arm I Patients undergo gadolinium-enhanced magnetic resonance imaging MRI of the brain at baseline to exclude CNS involvement and then once every 4 months or earlier if symptoms possibly related to CNS involvement develop in the absence of the development of CNS metastases
Arm II Patients undergo gadolinium-enhanced MRI of the brain at baseline to exclude CNS involvement and then once every 12 months or earlier if symptoms possibly related to CNS involvement develop in the absence of the development of CNS metastases
Patients complete neurological symptoms questionnaires at baseline every 6 weeks during study intervention and at the completion of the study
PROJECTED ACCRUAL A total of 96 patients will be accrued for this study
Primary
Determine survival without neurological symptoms due to CNS metastases in women with HER2neu-overexpressing stage IV breast cancer who undergo gadolinium-enhanced magnetic resonance imaging MRI of the brain once every 4 months vs once every 12 months for early detection of CNS metastases
Secondary
Determine the total number of therapeutic procedures ie gamma-knife radiotherapy or surgery required for the treatment of brain metastases in these women
Determine the total number of hospitalization days required in these women
Determine the overall survival of these women
Evaluate a cross-platform manufacturer-independent MRI technique for diagnosis of brain metastases that could be used in future studies in the IRIS and ULB-Canceropôle networks
Compare 2D-SE vs 3D-GE thin sections methods for post-contrast brain imaging in these women
OUTLINE This is a prospective randomized study Patients are randomized to 1 of 2 arms
Arm I Patients undergo gadolinium-enhanced magnetic resonance imaging MRI of the brain at baseline to exclude CNS involvement and then once every 4 months or earlier if symptoms possibly related to CNS involvement develop in the absence of the development of CNS metastases
Arm II Patients undergo gadolinium-enhanced MRI of the brain at baseline to exclude CNS involvement and then once every 12 months or earlier if symptoms possibly related to CNS involvement develop in the absence of the development of CNS metastases
Patients complete neurological symptoms questionnaires at baseline every 6 weeks during study intervention and at the completion of the study
PROJECTED ACCRUAL A total of 96 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 |
|---|---|---|---|
| EUDRACT-2006-001591 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000516004 | REGISTRY | None | None |
| EU-20655 | None | None | None |