Sentinel lymph node biopsy system for breast cancer

描述(申请人提供)：这项研究的长期目标是设计和开发一种专用的、影像引导的、微创的经皮腋窝前哨淋巴结活检系统，用于乳腺癌的分期。虽然腋窝淋巴结清扫仍然是乳腺癌分期的黄金标准，但在接受腋窝清扫的女性小乳腺癌患者中，超过70%的人被发现腋窝淋巴结阴性。建议的微创活检系统可以避免美国每年超过32,000名属于这一类别的妇女腋窝淋巴结清扫的发病率。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，我们将展示通过腋下一个非常小的切口安全地提取完整前哨淋巴结的临床可行性，并将所建议的系统与腋窝清扫作为分期工具的临床效果进行比较。该系统集成了空间相关的超声和核医学成像技术，以及计算机驱动的专用活检设备，为微创经皮哨兵结节活检提供了一个标准化平台。我们相信，这个计算机化的平台将为临床合适的患者更广泛地使用前哨淋巴结活检。

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.