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Slow Accural
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI | Active Comparator | MRI |
|
| No MRI | No Intervention | No MRI |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Other | Breast MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess if pre-operative MRI reduces incidence of re-excisions required | 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Total Mastectomy Rates | Total Mastectomy Rates | 2 years |
| Number of biopsies | The number of biopsies recommended and performed | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02215 | United States | ||
| Dana-Farber Cancer Institute |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Local-regional recurrence rates | Local-regional recurrence rates in participants undergoing local therapy | 2 years |
| Time from diagnosis to local therapy | The time from diagnosis to definitive local therapy | 2 years |
| Number of malignancies in contralateral breast | The number of malignancies identified int he contralateral breast | 2 years |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Faulkner Hospital | Boston | Massachusetts | 02215 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |