Sentinel lymph node biopsy system for breast cancer

描述（由申请人提供）：本研究的长期目标是设计和开发一种专用的、成像引导的、微创的、经皮腋窝前哨淋巴结活检系统，用于乳腺癌分期。虽然腋窝淋巴结清扫术仍然是乳腺癌分期的金标准，但超过70%的接受腋窝淋巴结清扫术的小乳腺肿瘤女性发现腋窝淋巴结阴性。在第一阶段，我们建立了准确识别和定位前哨淋巴结的技术可行性。在第二阶段，我们将证明通过腋窝非常小的切口安全地提取完整的前哨淋巴结的临床可行性，并将所提出的系统的临床疗效与腋窝淋巴结清扫作为分期工具进行比较。该系统集成了空间相关超声和核医学成像技术，以及计算机驱动的专用活检设备，为微创经皮前哨淋巴结活检提供标准化平台。我们相信，这个计算机化的平台将导致前哨淋巴结活检更广泛地用于临床适当的患者。

DESCRIPTION (provided by applicant): The long-term objective of this research is to design and develop a dedicated, imaging guided, minimally invasive, percutaneous axillary 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% of women with small breast tumors who undergo axillary 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 the U.S. In Phase I, we established the technical feasibility of accurately identifying and localizing sentinel nodes. In Phase II, we will demonstrate the clinical feasibility of safely extracting intact sentinel nodes through a very small incision in the axilla, and compare the clinical efficacy of the proposed system to axillary dissection as a staging tool. The proposed system integrates spatially correlated ultrasound and nuclear medicine imaging technologies, and computer driven, specialized biopsy devices, to provide a standardized platform for minimally invasive percutaneous sentinel node biopsy. We believe that this computerized platform will lead to more widespread use of sentinel node biopsy for clinically appropriate patients.