Randomized Trail of Breast MRI for Newly Diagnosed Early Stage Breast Cancer: Impact on Re-excision Lumpectomy
18 Years
N/A
Female
Breast Cancer
Trial Information
Randomized Trail of Breast MRI for Newly Diagnosed Early Stage Breast Cancer: Impact on Re-excision Lumpectomy
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Assess if pre-operative MRI reduces incidence of re-excisions required
Outcome Description:
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
Outcome Time Frame:
2 years
Safety Issue:
No
Authority:
United States: Institutional Review Board
Study ID:
11-330
NCT ID:
NCT01568346
Start Date:
February 2012
Completion Date:
March 2013
Related Keywords:
- Breast Cancer
- Newly diagnosed
- Early stage
- Breast Neoplasms
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Brigham and Women's Hospital | Boston, Massachusetts 02115 |
| Faulkner Hospital | Jamaica Plain, Massachusetts 02130 |
