The long-term objective of this research is to design and develop a dedicated, computerized, minimally invasive sentinel lymph node biopsy system for staging of breast cancer. While axillary lymph node dissection remains the gold standard of care for staging of breast cancer, over 70 percent of women with small breast tumors who undergo axillary lymph node dissection are found to have negative axillary nodes. The proposed minimally invasive biopsy system could spare the morbidity of axillary node dissection for over 32,000 women who fall into this category each year. In Phase I, we will establish the technical feasibility of accurately identifying and localizing the sentinel node. In Phase II, we will demonstrate the clinical feasibility of safely extracting the sentinel node intact through a very small incision in the axilla, and compare the clinical efficacy of the system to axillary dissection as a staging tool. The proposed system integrates spatially correlated ultrasound and nuclear medicine imaging technologies, as well as computer driven, specialized biopsy devices, to provide a standardized platform for minimally invasive sentinel node biopsy. We believe that the computerized platform will lead to more widespread use of sentinel node biopsy for clinically appropriate patients.
Our analysis indicates that the market for minimally invasive sentinel lymph node biopsy will support an initial annual sales volume of 70 units at an approximate price of $90,000 per unit. Initial units will be offered as an adjunct to the dedicated breast core biopsy systems installed in surgical centers worldwide.
