Recruiting

Cavity Shave Margins vs. Selective Margins

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT05825482

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

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

Study Details

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

Study ID

NCT05825482

Start date

Jul 17, 2023

Status verified date

Apr, 2026

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

204 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm 1

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

active comparator: Arm 2

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

Interventions

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.

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.

Primary outcome measure

  • Determine the difference in positive margin rate between the two methods. [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Wendy Catchpole

3303446348catchpw@ccf.org

Locations

Cleveland Clinic Akron General, Case Comprehensive Cancer Center

Recruiting

Akron, Ohio, United States, 44302

Contacts

Michael McNeal, BSN

330-344-6348mcnealm@ccf.org

Wendy Catchpole, BS

330-344-6348catchpw@ccf.org

Principal Investigator:

Andrew Fenton, MD

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-04-08.