Comparing 3D Digital Breast Tomosynthesis to Standard 2D Mammography During Breast-Conserving Surgery for Early Breast Cancer

What this Trial Is About

Breast-conserving surgery is a common treatment for early-stage breast cancer or ductal carcinoma in situ DCIS, aiming to remove the tumor completely with a clear margin of healthy tissue. If cancer cells are found at the edge of the removed tissue, a second surgery may be needed, which can delay treatment and increase anxiety and costs. This study compares the current standard imaging method using two-dimensional 2D specimen mammography with a newer three-dimensional 3D digital breast tomosynthesis technique performed during surgery to see if it improves margin assessment. Participants undergoing breast-conserving surgery will be randomly assigned to either standard 2D specimen mammography performed in the radiology department or 3D digital breast tomosynthesis performed directly in the operating theatre using the Mozart system. In both groups, the surgeon will review images during surgery to decide if more tissue needs removal. The study does not change standard surgical care or postoperative management. During the study, participants will have intraoperative imaging to assess tumor margins. Researchers will monitor outcomes such as the rate of positive margins on final pathology, need for additional surgery, operating time, and workflow efficiency. Follow-up will include reviewing the final histopathology reports and assessing surgery-related metrics. The study aims to determine if intraoperative 3D imaging improves surgical results and reduces the need for a second surgery.

Margin Optimisation Using Z-axis Assessment With Real-time Tomosynthesis (MOZART Study).