A Trial of the Selene System in Breast Conservation Surgery (H-50099)

A Prospective, Multi-Center, Randomized, Double-Arm Trial To Determine The Impact Of The SELENE System On Positive Margin Rates In Breast Conservation Surgery

This study is a randomized device trial intended for women who are planning on undergoing a lumpectomy for the treatment of invasive ductal carcinoma (IDC) and/or ductal carcinoma in situ (DCIS) cancer of the breast.

Patients will be randomized into 1 of 2 groups: 

1. Standard Surgery Control Arm (~33% chance)
2. Standard Surgery + SELENE arm (~66% chance)

The SELENE research device takes images of breast tissue removed during a lumpectomy to assess the margins between the normal and cancerous tissue. The goal of this study is to evaluate the ability of SELENE in assessing the borders between normal and abnormal breast tissue removed during breast lumpectomy surgery. 

The SELENE investigational device may provide the surgeon with information during the surgery that may reduce the chance that patients would need to come back for more surgery (if the pathologist’s report stated that not enough tissue was removed). The patient that standard-of-care pathology processing will still be performed on all specimens. SELENE is not meant to replace pathology but rather to give the surgeon information during the operation before the specimen is processed in the pathology lab.