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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: MRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MRI<br>MRI | Other: MRI<br>* Breast MRI<br>|
| No Intervention: No MRI<br>No MRI | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Mastectomy Rates | Total Mastectomy Rates | 2 years | 
| Number of biopsies | The number of biopsies recommended and performed | 2 years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Newly diagnosed, Early stage