Evaluating EndoScell Cellular Imaging Technology for Breast-Conserving Surgery and Sentinel Lymph Node Biopsy in Early Breast Cancer

What this Trial Is About

Breast cancer is a growing health concern, particularly in China where its incidence has rapidly increased. This research focuses on patients undergoing breast-conserving surgery combined with sentinel lymph node biopsy to evaluate a new intraoperative cellular detection technology called the EndoScell Scanner ES. The study aims to assess how well the ES technology can detect sentinel lymph node status during surgery compared to traditional methods, helping guide treatment decisions more quickly and accurately. The study uses the EndoScell Scanner, which employs a miniaturized fluorescence microscope system to capture ultra-high-resolution images at the cellular level during surgery. This device uses fluorescent dyes, including a new dye, mitoxantrone, for sentinel lymph node tracing to avoid interference effects. Alongside the ES technology, imprint cytology is also performed intraoperatively. Surgeons will primarily rely on imprint cytology results during surgery, while the ES technologys accuracy and image quality are assessed retrospectively. Participants will undergo sentinel lymph node biopsy with intraoperative evaluation using both the ES technology and imprint cytology. The study will measure the accuracy of ES in assessing lymph node status by comparing it to standard paraffin pathology results obtained about two weeks after surgery. Additional assessments include the quality of imaging, surgeon learning curves, detection time, and reoperation rates at three months. The total study duration for these outcomes is approximately one year, with continuous monitoring and data collection.

Application of EndoScell Intraoperative Cellular Probing Technology for Early-Stage Breast Cancer