Breast MRI for Newly Diagnosed Breast Cancer:Impact on Re-excision Lumpectomy



Status:Terminated
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/3/2016
Start Date:February 2012
End Date:March 2013

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Randomized Trail of Breast MRI for Newly Diagnosed Early Stage Breast Cancer: Impact on Re-excision Lumpectomy

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.

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.

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
We found this trial at
3
sites
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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Boston, Massachusetts 02133
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