204
Participants
Start Date
July 17, 2023
Primary Completion Date
November 30, 2025
Study Completion Date
November 30, 2026
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.
RECRUITING
Cleveland Clinic Akron General, Case Comprehensive Cancer Center, Akron
Case Comprehensive Cancer Center
OTHER