Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®

Study Overview
=================
Brief Summary
-----------------
This is a prospective study comparing partial mastectomy performed with routine cavity shave margins and Savi Scout® localization to partial mastectomy performed with selective margins and Savi Scout® localization. The primary objective is to determine the difference in positive margin rate between the two methods. The secondary objectives are to determine the differences in the rate of re-excision, volume of tissue extracted and Breast-Q® score between the two methods. It is hypothesized that the Savi Scout® will allow for decreased volume of tissue excised when compared to routine cavity shave margins without any difference in positive margin rate or rate of re-excision.

Detailed Description
-----------------
Over a period of 24 months, this study will recruit 204 women 18 years and older with stage I-II breast cancer or stage 0 DCIS that have been diagnosed by core needle biopsy and are planning to receive breast conserving surgery. After obtaining consent, the patient will be asked to complete the Breast-Q® questionnaire which should take about 10-15 minutes for the patient to complete. The patient will then be randomized in a 1:1 fashion to: Arm 1: Partial mastectomy with Savi Scout® localization and routine cavity shave margins Arm 2: Partial mastectomy with Savi Scout® localization and selective shave margins. Arm 1 and 2 patients will undergo preoperative Savi Scout® reflector placement under image guidance per routine care. The surgeons will be instructed to perform a partial mastectomy with routine cavity shave margins using Savi Scout® or partial mastectomy with selective margins using Savi Scout®. The lesion will be removed in the routine fashion. For patients in arm 1, the surgeons will use the Savi Scout® to perform routine cavity shave margins by extracting superior, lateral, inferior, medial, anterior, and posterior margins. For patients in arm 2, the Savi Scout® localizer will be utilized to determine selective shave margins by examining the same margins on the excised tissue specimen. The surgeon will obtain selective margins if the margin of the tissue specimen is within 1mm of invasive cancer and 2mm within DCIS. All surgeons participating in the study will undergo an educational session to ensure consistency. Tissue specimens will be processed per hospital policy and sectioned for gross evaluation. Tissue specimens will be assessed by the pathologists at Cleveland Clinic Akron General. This simulates typical pathology review. Positive margin rate is a categorical variable and will be reviewed by pathology board certified physicians and thus should have minimal interpersonal variation. At the postoperative visit, the patient will be asked to complete another Breast-Q® questionnaire.

Official Title
-----------------
Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Arm 1 Partial mastectomy with Savi Scout® localization and shave margins.
* Procedure: Arm 2 Partial mastectomy with Savi Scout® localization and selective shave margins.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 18 years and older, and With stage I-II invasive breast cancer, or Stage 0 DCIS, and That have been diagnosed by means of core needle biopsy appropriate for breast conserving therapy, and Present to Cleveland Clinic Akron General. Exclusion Criteria: Pregnant women Patients who underwent prior surgical interventions such as excisional biopsy for diagnosis or prior partial mastectomy Patients with a history of surgical intervention, except needle biopsy, on the ipsilateral breast Patients with a history of chest radiation to the ipsilateral breast Patients who have received neoadjuvant chemotherapy or endocrine therapy Patients diagnosed with bilateral breast cancer.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Partial mastectomy with Savi Scout® localization and routine cavity shave margins | Procedure: Arm 1 Partial mastectomy with Savi Scout® localization and shave margins.<br>* Patients will undergo preoperative Savi Scout® reflector placement under image guidance per routine care. Patients will undergo randomization. With Arm 1 randomization, the surgeons will be instructed to perform a partial mastectomy with routine cavity shave margins using Savi Scout® localization. The lesion will be removed in the routine fashion. The surgeons will use the Savi Scout® to perform routine cavity shave margins by extracting superior, lateral, inferior, medial, anterior, and posterior margins.<br>|
| Active Comparator: Arm 2<br>Partial mastectomy with Savi Scout® localization and selective shave margins. | Procedure: Arm 2 Partial mastectomy with Savi Scout® localization and selective shave margins.<br>* Patients will undergo preoperative Savi Scout® reflector placement under image guidance per routine care. Patients will undergo randomization. With Arm 2 randomization, the surgeons will be instructed to perform a partial mastectomy with selective margins shave margins using Savi Scout®. The lesion will be removed in the routine fashion. The Savi Scout® localizer will be utilized to determine selective shave margins by examining the same margins on the excised tissue specimen. The surgeon will obtain selective margins if the margin of the tissue specimen is within 1mm of invasive cancer and 2mm within DCIS.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the difference in positive margin rate between the two methods. | The primary objective is to determine the difference in positive margin rate between the two methods. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the rate of re-excision between the two methods. | Determine the difference in the rate of re-excision between the two methods. | 24 months | 
| Difference in the volume of tissue extracted between the two methods. | Determine the difference in the volume of tissue extracted between the two methods. | 24 months | 
| Difference in the Breast-Q® score between the two methods. | Determine the difference in the Breast-Q® score between the two methods. | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Savi Scout, Shave margin, Selective margin, Breast-Q