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Breast Margin Study: Savi Scout® for Breast Cancer Surgery

This study is for women aged 18 and older with early-stage breast cancer (Clinical stage I-II invasive breast cancer or Stage 0 DCIS) who are planning to have breast-conserving surgery. It compares two methods of removing breast cancer using a device called Savi Scout®. One method involves removing a routine amount of surrounding tissue (routine cavity shave margins), while the other removes tissue more selectively (selective shave margins). The main goal is to see if one method results in fewer positive margins (cancer cells found at the edge of the removed tissue) after 24 months. The study is also looking at how much tissue is removed and the need for additional surgeries. This study aims to enroll 204 participants.

Study design
This is an interventional study comparing two surgical approaches using Savi Scout® localization, with 204 women expected to participate.
What's involved
You would complete a questionnaire, have a Savi Scout® reflector placed, and undergo a partial mastectomy using one of the two methods being studied.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome of the study will be measured at 24 months after surgery.

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NCT05825482

Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®

Recruiting
NAAges 18+InterventionalTreatment
Case Comprehensive Cancer Center
~204 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:Arm 1 Partial mastectomy with Savi Scout® localization and shave margins.Arm 2 Partial mastectomy with Savi Scout® localization and selective shave margins.

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the difference in positive margin rate between the two methods.
Measured over 24 months

Conditions

Breast Cancer

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Breast CarcinomaBreast Ductal Carcinoma In Situ

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Andrew Fenton, M.D. · PRINCIPAL_INVESTIGATOR · Cleveland Clinic Akron General, Case Comprehensive Cancer Center

Who to contact

Wendy Catchpole
[email protected]
3303446348
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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.