Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®
- Conditions
- Breast Cancer
- Interventions
- 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.
- Registration Number
- NCT05825482
- Lead Sponsor
- Case Comprehensive Cancer Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 204
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Arm 1 Partial mastectomy with Savi Scout® localization and shave margins. Partial mastectomy with Savi Scout® localization and routine cavity shave margins Arm 2 Arm 2 Partial mastectomy with Savi Scout® localization and selective shave margins. Partial mastectomy with Savi Scout® localization and selective shave margins.
- Primary Outcome Measures
Name Time Method Determine the difference in positive margin rate between the two methods. 24 months The primary objective is to determine the difference in positive margin rate between the two methods.
- Secondary Outcome Measures
Name Time Method Difference in the BREAST-Q® Version 2.0 Breast Conserving Therapy Module Pre- and Postoperative Scales 24 months Determine the difference in the Breast-Q® scores between the two methods. Scores range from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
Difference in the rate of re-excision between the two methods. 24 months Determine the difference in the rate of re-excision between the two methods.
Difference in the volume of tissue extracted between the two methods. 24 months Determine the difference in the volume of tissue extracted between the two methods.
Trial Locations
- Locations (1)
Cleveland Clinic Akron General, Case Comprehensive Cancer Center
🇺🇸Akron, Ohio, United States