Imaging Probe: Lymph Node Identification & Localization

该提案的目标是优化第一阶段开发的原型手持式成像相机，包括显著的性能改进和自动图像分析技术的增加，以及在临床研究中对相机进行评估。照相机的功能是对注射到癌症患者体内的放射性标记胶体的分布进行成像，以定位原发肿瘤引流路径中的前哨淋巴结（SLN）。SLN与恶性细胞的扩散有关，因此SLN的病理学指示癌症的扩散。注入的胶体的扩散可以采取一条或多条路径，它可以保持在原生盆地附近，也可以传播到遥远的非直观节点盆地。这些模糊性使得SLN本地化具有挑战性，并且只有少数经验丰富的专家在SLN本地化方面非常成功。在本项目下开发的成像探针有助于SLN定位。该探针可在术前和术中用于追踪胶体的路径并识别SLN。在第二阶段，该设备的一项创新将是自动图像分析技术，允许用户快速扫描可疑区域，并在摄像头检测到胶体浓度时通知用户。以这种方式，用户被警告应该成像的区域。手持摄像机有望减少定位SLN的平均手术时间，减少获得熟练程度所需的手术次数，增加SLN定位的信心，并最大限度地减少手术干预。将进行临床研究，以评价术前和术中成像器械的有效性和实用性。在SLN定位方面缺乏经验的核医学医师将在术前评估成像探头的使用，而SLN经验丰富的外科医生将在术中测试该器械。医生提供的反馈将有助于II期优化过程。拟议的商业应用：该项目将产生一种成像探针，以极大地促进在黑色素瘤和乳腺癌以及其他潜在肿瘤类型的分期期间定位前哨淋巴结。在相同的成本下，成像探头提供了比当前采用的非成像探头更大的优势。前哨淋巴结闪烁成像的动态领域在接受度和范围上都在增长。许多医院常规使用超声造影术，并可以使用该探头增强程序。这里开发的成像探头，在没有额外成本浪费非成像探头，将为医生提供一个更多功能的仪器，可以携带哨兵节点技术更远，更快。

The objectives of the proposal are optimization of the prototype hand- held imaging camera developed in Phase I, including significant performance improvements and addition of automated image analysis techniques, and evaluation of the camera in clinical studies. The function of the camera is to image distributions of a radiolabeled colloid injected into cancer patients to localize the sentinel lymph node (SLN) in the drainage path of the primary tumor. SLN have been implicated in the spread of malignant cells so the pathology of the SLN is indicative of the spread of cancer. The spread of the colloid from injection can take one or many paths and it may remain close to the primary or travel to distant non-intuitive node basins. These ambiguities make SLN localization challenging and only a handful of experienced specialist are highly successful in SLN localization. The imaging probe developed under this project facilitates SLN localization. The probe can be used before and during surgery to trace the path of the colloid and identify the SLN. One innovation added to the device in Phase II will be automatic image analysis techniques that allow the user to rapidly scan over suspected regions and be notified when concentrations of colloid are detected by the camera. In this way the user is alerted to areas that should be imaged. The hand-held camera promises to reduce the mean surgical time to localize SLN, reduce the number of procedures required to obtain proficiency, increase confidence in SLN localization and minimize surgical intervention. Clinical studies will be conducted to evaluate the effectiveness and utility of the imaging device both preoperatively and intraoperatively. Nuclear medicine physicians inexperienced in SLN localization will evaluate use of the imaging probe presurgically, and SLN experienced surgeons will test the device intraoperatively. Feedback provided by the physicians will contribute to the Phase II optimization process. PROPOSED COMMERCIAL APPLICATIONS: This project will result in an imaging probe to greatly facilitate the localization of the Sentinel Lymph Node during the staging of melanoma and breast cancer, among other potential tumor types. The imaging probe offers great advantages over the currently employed non-imaging probes at the same cost. The dynamic field of Sentinel Node Scintigraphy is growing in acceptance and scope. Many hospitals routinely use Lymphoscintigraphy and could enhance the procedure with this probe. The imaging probe developed here, at no extra cost to wasting non- imaging probes, will provide physicians with a more functional instrument that can carry the Sentinel Node technique further and faster.