Confocal Histolog Scanner in Routine Breast-Conserving Surgery

What this Trial Is About

Breast cancer is the most common cancer in women, and many are diagnosed each year with ductal carcinoma in situ (DCIS), which can progress to invasive cancer without treatment. Breast conserving surgery (BCS) is the most common surgical treatment for early-stage breast cancer or DCIS. There is a need for faster and more accurate methods to assess breast tissue margins during surgery to ensure tumor-free margins and reduce the need for reoperation. This study evaluates the use of the Histolog Scanner (HLS), a CE-marked confocal laser scanning microscope designed to image excised breast tissue specimens intraoperatively. The HLS aims to help surgeons identify cancer-positive margins in real time, allowing immediate removal of additional tissue if needed. The study collects data from the use of HLS in routine breast conserving surgeries without adding invasive or burdensome procedures compared to standard care. Participants will undergo breast conserving surgery where the HLS is used to assess tissue margins during the operation. Researchers will measure reoperation rates due to cancer-positive margins within one month after surgery, as well as detection rates, usability of the device, economic impact, and safety over one year. Outcomes include agreement between HLS assessments and final pathology, time of device use, hospital costs, and any adverse device effects. The study is sponsored by the University of Fribourg and started in June 2025 with follow-up lasting up to 14 months.

Confocal Histolog Scanner in Routine Breast-Conserving Surgery (CHiB)