Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®
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
| Condition(s) | Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria * Women 18 years and older, and * With Clinical 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. * Subjects must have pathologically confirmed breast carcinoma or ductal carcinoma in situ. * Performance status: ECOG 0-1 * Subjects must have the ability to understand and the willingness to sign a written informed consent document. * Patients may have received or may be receiving endocrine therapy. Exclusion Criteria * Men * Pregnant women * Patients who have received neoadjuvant chemotherapy for current cancer diagnosis. * Patients with current diagnosis of synchronous bilateral breast cancer. (A diagnosis of breast c |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Case Comprehensive Cancer Center |
| Locations | Akron, Ohio, United States |
| Start date | 2023-07-17 |
| NCT ID | NCT05825482 |
| Official listing | https://clinicaltrials.gov/study/NCT05825482 |