Breast Cancer Clinical Trial
Breast MRI for Newly Diagnosed Breast Cancer:Impact on Re-excision Lumpectomy
Summary
This study is being done to find out the number of surgical procedures required to achieve clear margins in women with newly diagnosed early stage breast carcinoma. The investigators are also looking at the number of additional biopsies performed before surgery, the mastectomy rate, detection of breast cancer on the opposite side (contralateral carcinoma), time form diagnosis to local therapy, and evaluation time to local recurrence.
Full Description
This is a prospective pragmatic trial randomizing women diagnosed with early stage breast cancer to MRI versus no breast MRI. Data analyzed will include medical record information abstracted from the clinical records. Date and modality of all imaging performed, malignancy(s) identified, abnormalities identified, image guided procedures performed, surgical procedures performed and pathology results.
The primary aim of this study is to assess if the use of pre-operative MRI can reduce the incidence of re-excisions required to achieve clear margins in women with newly diagnosed early stage breast carcinoma.
Eligibility Criteria
Inclusion Criteria:
Must undergo definitive local therapy with either breast conserving therapy or mastectomy
Clinical Stage 0, I or II breast cancer based on examination and/or conventional imaging of mammogram with or without ultrasound. Tumors must be less than 5 cm in size and the patient clinically node negative
Able to undergo breast MRI
Exclusion Criteria:
Not pregnant or breastfeeding
No prior breast MRI for the newly diagnosed carcinoma at the outside hospital
No prior mantle radiation
No locally advanced breast cancer
No diffuse malignant appearing microcalcifications requiring mastectomy
No known collagen vascular disease
No previous ipsilateral radiation
No participants who undergo surgery at an outside institution
No prior history of breast carcinoma
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There is 1 Location for this study
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
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