Comparing two methods of breast cancer surgery using Savi Scout® localization
Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®
This study is testing two different surgical methods for removing breast cancer in women to see which one leads to better outcomes and fewer follow-up surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Akron, Ohio) |
| Trial ID | NCT05825482 on ClinicalTrials.gov |
What this trial studies
This prospective study aims to compare two surgical approaches for partial mastectomy in women with early-stage breast cancer. One group will undergo routine cavity shave margins while the other will have selective margins, both utilizing Savi Scout® localization. The primary goal is to assess the difference in positive margin rates between the two methods, while secondary objectives include evaluating re-excision rates, tissue volume excised, and patient-reported outcomes using the Breast-Q® questionnaire. The study will enroll 204 women over 24 months, all of whom will be randomized into one of the two surgical arms.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with stage I-II breast cancer or stage 0 DCIS who are planning to undergo breast conserving surgery.
Not a fit: Patients who are men, pregnant, or have received neoadjuvant chemotherapy for their current cancer diagnosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective surgical techniques that minimize tissue removal while maintaining cancer control.
How similar studies have performed: Similar studies have shown promise in optimizing surgical margins in breast cancer surgery, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Akron, Ohio
- Cleveland Clinic Akron General, Case Comprehensive Cancer Center — Akron, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Andrew Fenton, M.D. — Cleveland Clinic Akron General, Case Comprehensive Cancer Center
- Study coordinator: Wendy Catchpole
- Email: catchpw@ccf.org
- Phone: 3303446348
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.