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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Arm 1 Partial mastectomy with Savi Scout® localization and shave margins.; Procedure: Arm 2 Partial mastectomy with Savi Scout® localization and selective shave margins.

Detailed Description

Over a period of 24 months, this study will recruit 204 women 18 years and older with stage I-II breast cancer or stage 0 DCIS that have been diagnosed by core needle biopsy and are planning to receive breast conserving surgery.

After obtaining consent, the patient will be asked to complete the Breast-Q® questionnaire which should take about 10-15 minutes for the patient to complete. The patient will then be randomized in a 1:1 fashion to:

Arm 1: Partial mastectomy with Savi Scout® localization and routine cavity shave margins

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

Arm 1 and 2 patients will undergo preoperative Savi Scout® reflector placement under image guidance per routine care. The surgeons will be instructed to perform a partial mastectomy with routine cavity shave margins using Savi Scout® or partial mastectomy with selective margins using Savi Scout®. The lesion will be removed in the routine fashion. For patients in arm 1, the surgeons will use the Savi Scout® to perform routine cavity shave margins by extracting superior, lateral, inferior, medial, anterior, and posterior margins. For patients in arm 2, 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. All surgeons participating in the study will undergo an educational session to ensure consistency.

Tissue specimens will be processed per hospital policy and sectioned for gross evaluation. Tissue specimens will be assessed by the pathologists at Cleveland Clinic Akron General. This simulates typical pathology review. Positive margin rate is a categorical variable and will be reviewed by pathology board certified physicians and thus should have minimal interpersonal variation.

At the postoperative visit, the patient will be asked to complete another Breast-Q® questionnaire.

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wendy Catchpole; Phone Number: 3303446348; Email: catchpw@ccf.org

Study Locations

• United States
  • Ohio
    • Akron, Ohio, United States, 44302
      • Recruiting
      • Cleveland Clinic Akron General, Case Comprehensive Cancer Center
      • Contact: Michael McNeal, BSN; Phone Number: 330-344-6348; Email: mcnealm@ccf.org
      • Contact: Wendy Catchpole, BS; Phone Number: 330-344-6348; Email: catchpw@ccf.org
      • Principal Investigator: Andrew Fenton, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1; Partial mastectomy with Savi Scout® localization and routine cavity shave margins	Procedure: Arm 1 Partial mastectomy with Savi Scout® localization and shave margins.; 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.
Active Comparator: Arm 2; Partial mastectomy with Savi Scout® localization and selective shave margins.	Procedure: Arm 2 Partial mastectomy with Savi Scout® localization and selective shave margins.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the rate of re-excision between the two methods.	Determine the difference in the rate of re-excision between the two methods.	24 months
Difference in the volume of tissue extracted between the two methods.	Determine the 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	Determine the difference in the Breast-Q® scores between the two methods. Scores range from 0 (worst) to 100 (best). Higher scores reflect a better outcome.	24 months

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Andrew Fenton, M.D., Cleveland Clinic Akron General, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer; Breast-Q; Savi Scout; Shave margin; Selective margin
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: CASE5122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No