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

NCT05825482 | Recruiting

• 1 other identifier: CASE5122
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Savi Scout; Shave margin; Selective margin; Breast-Q

Outcome Measures

Primary Outcomes (1)

• Determine the difference in positive margin rate between the two methods.

  The primary objective is to determine the difference in positive margin rate between the two methods.

  24 months

Secondary Outcomes (3)

• Difference in the rate of re-excision between the two methods.

  24 months

• Difference in the volume of tissue extracted between the two methods.

  24 months

• Difference in the BREAST-Q® Version 2.0 Breast Conserving Therapy Module Pre- and Postoperative Scales

  24 months

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Partial mastectomy with Savi Scout® localization and routine cavity shave margins

Procedure: Arm 1 Partial mastectomy with Savi Scout® localization and shave margins.

Arm 2

ACTIVE COMPARATOR

Partial mastectomy with Savi Scout® localization and selective shave margins.

Procedure: Arm 2 Partial mastectomy with Savi Scout® localization and selective shave margins.

Interventions

Arm 2 Partial mastectomy with Savi Scout® localization and selective shave margins. PROCEDURE

Patients will undergo preoperative Savi Scout® reflector placement under image guidance per routine care. Patients will undergo randomization. With Arm 2 randomization, the surgeons will be instructed to perform a partial mastectomy with selective margins shave margins using Savi Scout®. The lesion will be removed in the routine fashion. The Savi Scout® localizer will be utilized to determine selective shave margins by examining the same margins on the excised tissue specimen. The surgeon will obtain selective margins if the margin of the tissue specimen is within 1mm of invasive cancer and 2mm within DCIS.

Arm 2

Arm 1 Partial mastectomy with Savi Scout® localization and shave margins. PROCEDURE

Patients will undergo preoperative Savi Scout® reflector placement under image guidance per routine care. Patients will undergo randomization. With Arm 1 randomization, the surgeons will be instructed to perform a partial mastectomy with routine cavity shave margins using Savi Scout® localization. The lesion will be removed in the routine fashion. The surgeons will use the Savi Scout® to perform routine cavity shave margins by extracting superior, lateral, inferior, medial, anterior, and posterior margins.

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Akron General, Case Comprehensive Cancer Center

Akron, Ohio, 44302, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Andrew Fenton, M.D.

  Cleveland Clinic Akron General, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy Catchpole

CONTACT

3303446348; catchpw@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: July 17, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)