Actively Recruiting
Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®
Led by Case Comprehensive Cancer Center · Updated on 2026-04-08
204
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women 18 years and older
- Clinical stage I-II invasive breast cancer or stage 0 ductal carcinoma in situ
- Diagnosis made by core needle biopsy appropriate for breast conserving therapy
- Patients presenting to Cleveland Clinic Akron General
- Pathologically confirmed breast carcinoma or ductal carcinoma in situ
- Performance status of ECOG 0-1
- Ability and willingness to provide written informed consent
- May have received or currently receiving endocrine therapy
You will not qualify if you...
- Men
- Pregnant women
- Patients who have received neoadjuvant chemotherapy for current cancer diagnosis
- Patients with synchronous bilateral breast cancer (except if prior breast cancer diagnosis was at least one year before current diagnosis)
- Patients under 18 years of age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cleveland Clinic Akron General, Case Comprehensive Cancer Center
Akron, Ohio, United States, 44302
Actively Recruiting
Research Team
W
Wendy Catchpole
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here