Magnetic Resonance Imaging for the Early Detection of CNS Metastases in Women With Stage IV Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00398437|
Recruitment Status : Unknown
Verified March 2007 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : November 10, 2006
Last Update Posted : August 12, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Metastatic Cancer||Biological: trastuzumab Drug: chemotherapy Procedure: magnetic resonance imaging||Not Applicable|
- Determine survival (without neurological symptoms due to CNS metastases) in women with HER2/neu-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.
- Determine the total number of therapeutic procedures (i.e., 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|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|
|Study Start Date :||September 2006|
- Survival without neurological symptoms due to brain metastasis and/or leptomeningeal involvement
- Total number of therapeutic procedures (i.e., gamma-knife, radiotherapy, or surgery) required for the treatment of brain metastases
- Total number of hospitalization days required
- Overall survival
- Cross-platform, manufacturer-independent magnetic resonance imaging technique for diagnosis of brain metastases
- Comparative evaluation of 2D-SE vs 3D-GE thin sections methods for post-contrast brain imaging
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00398437
|Institut Jules Bordet||Recruiting|
|Brussels, Belgium, 1000|
|Contact: Fabienne Lebrun, MD 32-25-413-791|
|Centre Hospitalier Universitaire Brugmann||Recruiting|
|Brussels, Belgium, B 1020|
|Contact: Andre Efira, MD 32-2-477-2903 email@example.com|
|Centre Hospitalier Etterbeek Ixelles||Recruiting|
|Brussels, Belgium, B-1050|
|Contact: Jean-Pierre D. Kains, MD 32-2-641-4851 firstname.lastname@example.org|
|Study Chair:||Fabienne Lebrun, MD||Jules Bordet Institute|