Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®
Recruiting · NCT05825482 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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 cancer at least one year prior to current cancer diagnosis is acceptable.)
- Patients \< 18 years of age.
Where it is running
1 location listed across 1 US state.
- Cleveland Clinic Akron General, Case Comprehensive Cancer Center - Akron, Ohio, United States