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

NARecruitingINTERVENTIONAL
Enrollment

204

Participants

Timeline

Start Date

July 17, 2023

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2026

Conditions
Breast Cancer
Interventions
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.

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.

Trial Locations (1)

44302

RECRUITING

Cleveland Clinic Akron General, Case Comprehensive Cancer Center, Akron

All Listed Sponsors
lead

Case Comprehensive Cancer Center

OTHER