Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment

Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment in a Single-centric PMPF Study (SHIELD)

This PMPF study is proposed to evaluate in real life the reoperation rates (ROR) of breast cancer and/or DCIS surgery when including the use of the HLS in the context of breast lumpectomy margin assessment.

Inclusion Criteria:

• Adult female Subject ≥18 years old.
• Subject Scheduled for breast conserving surgery of invasive and/or in-situ ductal carcinoma.
• Subject is able to read, understand and sign the informed consent.

Exclusion Criteria:

• Subject previously treated for ipsilateral breast cancer and/or ductal carcinoma in situ surgery.
• Subject with previous radiotherapy of the ipsilateral breast.
• Subject with multicentric/multilateral breast cancer.
• Subject with planned mastectomy, tumor-adapted breast reduction.
• Subject with pre-surgical/ preoperative neo-adjuvant treatment.
• Subject is pregnant/ lactating.
• Participation in any other clinical study that would affect data acquisition.