Breast MRI as a Preoperative Tool for DCIS
Breast MRI is a fairly new technology, but it has been well studied. It is now used routinely in many patients with breast cancer. It has been shown to be useful in detecting areas of cancer that cannot be seen using other types of scans or tests.
The purpose of this study is to see how often MRI can find other areas of cancer in women with one area of breast cancer, and to determine how having the MRI test affects their treatment. The purpose is also to study any areas of abnormality seen on your MRI with special methods that allow the images of your breast tissue and the microscopic analysis of your breast tissue to be compared very carefully. The study also aims to follow women who enter the study over a 10-year period to determine how often the breast cancer comes back.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Breast MRI as a Preoperative Tool for DCIS|
- To prospectively evaluate the value of preoperative breast MRI in women with core biopsy-proven DCIS. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
- To determine the proportion of all patients in this study in whom breast MRI identifies at least one site of cancer separate from the index lesion. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
- To estimate re-excision rates and mastectomy rates in patients with DCIS undergoing preoperative MRI. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
- To estimate the proportion of patients with DCIS in which preoperative MRI will change surgical planning. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
- To estimate the long-term ipsilateral breast recurrence rate in women with DCIS undergoing preoperative breast MRI. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Women with core biopsy proven DCIS with or without microinvasion seen for surgical consultation at Memorial Sloan-Kettering Cancer Center and for whom operative intervention is planned.
The patient will then undergo a breast MRI as part of their preoperative work-up of DCIS. Biopsy of any suspicious areas by needle biopsy or at the time of surgery. If appropriate, repeat MRI after biopsy or surgery. Follow-up for 10 years (you will be contacted once a year to see how you are doing).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00605982
|United States, New Jersey|
|Memoral Sloan Kettering Cancer Center|
|Basking Ridge, New Jersey, United States|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Kimberly Van Zee, MD||Memorial Sloan-Kettering Cancer Center|