Imaging Probe: Lymph Node Identification & Localization

该提案的目标是优化在第一阶段开发的手持式成像相机原型，包括显著的性能改进和增加自动图像分析技术，以及在临床研究中对相机进行评估。该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的病理改变预示着癌症的扩散。来自注入的胶体的扩散可以走一条或多条路径，它可能保持在靠近原生体的位置，或者移动到遥远的非直观的结点盆地。这些模糊性使得SLN本地化具有挑战性，只有少数有经验的专家在SLN本地化方面非常成功。在该项目下开发的成像探头有助于SLN的定位。该探头可以在手术前和手术中使用，以追踪胶体的路径并识别SLN。在第二阶段增加的一项创新是自动图像分析技术，允许用户快速扫描可疑区域，并在相机检测到胶体浓度时得到通知。通过这种方式，提醒用户应该成像的区域。手持式摄像机承诺减少定位SLN的平均手术时间，减少熟练掌握SLN所需的手术次数，增加对SLN定位的信心，并将手术干预降至最低。将进行临床研究，以评估术前和术中成像设备的有效性和实用性。在SLN定位方面缺乏经验的核医学医生将对成像探头的使用进行加压评估，而有SLN经验的外科医生将在术中测试该设备。医生提供的反馈将有助于第二阶段的优化过程。拟议的商业应用：该项目将产生一种成像探测器，在黑色素瘤和乳腺癌等潜在肿瘤类型的分期过程中，极大地促进前哨淋巴结的定位。成像探头在相同成本下提供了比目前使用的非成像探头更大的优势。哨兵节点闪烁成像的动态领域正在被越来越多的人接受，范围越来越广。许多医院经常使用淋巴核素扫描，并可以使用这种探头来增强检查程序。这里开发的成像探头，在不浪费非成像探头的情况下，将为医生提供功能更强大的仪器，可以更远、更快地携带哨兵节点技术。

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.