SPECTROSCOPIC DYE BASED LOCALIZATION OF LYMPH NODES

Spectrs公司正在开发一种指导系统，帮助定位乳腺癌的前哨淋巴结。在第一阶段支持下，将开发一种探测器，用于准确定位结节，而不需要目前使用的放射性氚示踪剂。光谱系统对探测器周围的组织进行光谱分析。通过指示探针何时指向深度达5厘米的含有异硫氰蓝的组织，获得诊断性活组织检查的可能性增加。这项核心技术已经在动物身上得到验证，可以将针引导到目标部位，并在人类身上通过完整的头骨检测脑出血。在第一阶段，现有的光谱探测器将被改装，以便在节点定位期间使用。在光学吸收和散射方面与人体组织相似的模型系统将被构建来校准和测试探头。根据IRB的批准，将从计划使用异硫氰蓝进行活检的患者体内收集腋窝淋巴结数据。探头对结节(S)的定位将与手术确定的实际位置交叉验证。该项目的结果将是一种用于定位异硫丹阳性淋巴的光学探头，并将在人类受试者中进行试点数据。拟议的商业应用：SPERS将开发一种用于前哨结节活检的商业指导系统。乳腺癌是导致女性死亡的主要原因。准确的结节活检是治疗选择和患者生存的关键。100-20万患者/年是哨兵结节活组织检查的候选对象。改进的淋巴活检系统的市场估计为每年20-40毫米(1995年乳房市场为9.16亿美元)。还设想了对局部治疗和靶向药物输送的扩展。

Spectros Corporation is developing a guidance system that assists with the localization of sentinel lymph nodes in breast cancer. Under Phase I support, a probe will be developed for accurate node localization without need for the radioactive technetium tracer currently used. The Spectros system spectroscopically analyzes tissue surrounding a probe. By indicating when the probe is pointed toward tissue containing Isosulfan Blue at a depth of up to 5 cm, the likelihood of obtaining a diagnostic biopsy is increased. The core technology has been validated in animals to guide needles to target sites, and in humans to detect cerebral hemorrhage through the intact skull. In Phase I, an existing Spectros probe will be modified for use during node localization. Model systems, similar in optical absorbance and scattering to human tissue, will be constructed to calibrate and test the probe. Under IRB approval, in vivo axillary node data will be collected from patients scheduled to have biopsy performed using Isosulfan Blue. Localization of the node(s) by the probe will be cross-validated with actual location as determined surgically. The result of this project will be an optical probe for localization of Isosulfan-positive lymph nodes, with pilot data in human subjects. PROPOSED COMMERCIAL APPLICATIONS: Spectros will develop a commercial guidance system for sentinel node biopsy. Breast cancer is a leading cause of death in women. Accurate node biopsy is key to treatment selection and patient survival. 100-200K patients/year are sentinel node biopsy candidates. The market for an improved lymph biopsy system is estimated at $20-40MM/year (1995 breast ca. market was $916MM). Extensions to focal therapeutics and targeted drug delivery are envisioned.