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

Condition(s) studied

Investigational drug(s) / intervention(s)

EndoScell Scaner (ES) novel intraoperative cellular probing technology: In this project, we utilize the miniature wide-angle focusing microscope for intraoperative cell-level observation and detection, a technology in which our hospital has conducted extensive research and accumulated rich experience.

Study summary

Sentinel Lymph Node Biopsy (SLNB) is a common surgical treatment for breast cancer and a primary method for assessing the pathological status of axillary lymph nodes. Precise intraoperative detection of sentinel lymph nodes during surgery assists in timely evaluation of axillary lymph node pathology and helps in formulating further treatment strategies.

Touch imprint cytology (TIC) is one of the most commonly used intraoperative detection techniques. The new intraoperative cellular detection technology, EndoScell Scanner (ES), uses an improved real-time miniaturized fluorescence microscopy system for image acquisition. The ultra-high-resolution images obtained can reach the cellular level. In previous studies, the accuracy and sensitivity of this technology for intraoperative detection of sentinel lymph nodes were comparable to imprint cytology, but it is much more rapid. The detection technology uses fluorescein sodium and methylene blue as fluorescent dyes, which is non-invasive and also non-consumptive of tissue samples.

This study involves patients scheduled for sentinel lymph node biopsy and aims to evaluate the clinical application value of the EndoScell Scanner (ES) for intraoperative assessment of the pathological status of sentinel lymph nodes through a prospective self-controlled study. To avoid the potential impact of methylene blue on the ES detection technology, we will use mitoxantrone as a new dye for sentinel lymph node tracing in this study.

The primary study objective is to compare the accuracy of the ES detection technology in assessing sentinel lymph node status, using paraffin pathology examination as the gold standard. The primary endpoint is the accuracy of the ES technology. Secondary endpoints include the image quality score of the ES detection, the learning curve of the surgeons, and the time required for detection.

Eligibility

Primary outcome measure(s)

• The accuracy of ES technology — After the final pathological results are obtained, it is usually about 2 weeks after surgery
  the accuracy of the ES technology （including accuracy, sensitivity and specificity）
• The reoperation rate — 3 months after surgery
  The proportion of reoperations due to a positive margin

Trial sites (1)

More Fudan University trials in China

Other trials for the same condition