Breast Cancer Locator

项目总结/摘要： CairnSurgical LLC是达特茅斯的一家分拆公司，将优化和测试多中心临床可行性， 乳腺癌保乳手术（BCS）中的一种新的图像引导介入设备--乳腺癌微导管（BCL） （i）消除导丝定位--一种适度有效、稍微昂贵且肯定不方便的程序 对于患者和外科医生-同时（ii）减少阳性切缘率和随后的再次切除 手术-不仅对病人而且对医疗保健费用都是一个重大但不必要的负担。 具体而言，BCL是一种患者特异性的3D打印设备，其允许多种药物的准确临床转移。 通过目前可用的其他竞争技术无法获得的手术提示，包括i）肿瘤 从切口部位观察时投射在乳房表面上的轮廓，ii）术中放置的金属丝 其限定了从切口部位到肿瘤的直接路径，iii）最大肿瘤范围的间质着墨 使用创新的进入端口系统，以及4）从前肿瘤边缘到乳房表面的距离 肿瘤后缘与胸壁相连在拟议的II期研究中，CairnSurgical将与 与达特茅斯的研究人员和四个合作机构的外科医生一起，1）改进BCL模型的创建 通过消除对光学扫描的需要来提高过程效率，并在10- 达特茅斯的患者研究，2）开发BCL Planner软件以简化BCL创建和质量保证 流程，并优化BCL生产，包装和交付，以实现制造和规模化 3）在大约12名患者中，在四个遥远的临床地点测试BCL的可行性， 可触及的乳腺癌质量保证和验证数据（临床和非临床）来自 这些研究将支持BCL器械的510（k）监管申报。正利润率与 当代BCS高（~22%-42%）9-13，并对患者造成显著的压力和乳腺癌的成本 健康护理关于手术切缘对局部复发影响的荟萃分析也证实， 切缘有积极的预后作用。因此，CairnSurgical在探索和商业上处于有利地位。 开发一种可能改变实践的BCS方法，用于乳腺癌的准确切除。

PROJECT SUMMARY/ABSTRACT: CairnSurgical LLC, a Dartmouth spin-off company, will optimize and test multi-site clinical feasibility of a new image-guided intervention device, the Breast Cancer Locator (BCL), in breast conserving surgery (BCS) to (i) eliminate wire localization - a moderately effective, somewhat costly and certainly inconvenient procedure for patients and surgeons - and concomitantly to (ii) reduce positive margin rates and subsequent re-excision surgeries - a significant but unnecessary burden not only on patients but also on the cost of healthcare. Specifically, BCL is a patient-specific, 3D printed device that allows accurate clinical transfer of multiple surgical cues not available through other competing technologies currently available, including i) a tumor silhouette projected on the breast surface as viewed from the incision site, ii) an intra-operatively placed wire that defines a direct path to the tumor from the incision site, iii) interstitial inking of the maximum tumor extents using an innovative system of access ports, and 4) distances from the anterior tumor edge to breast surface and the posterior tumor edge to the chest wall. In the proposed Phase II studies, CairnSurgical will collaborate with Dartmouth researchers and surgeons at four partnering institutions to 1) improve BCL model creation process efficiency by eliminating the need for optical scanning and clinically validate the approach in a 10- patient study at Dartmouth, 2) develop BCLPlanner software to streamline BCL creation and quality assurance processes, and optimize BCL production, packaging and delivery to achieve manufacturing and scale-up efficiencies, and 3) test the feasibility of BCL at four distant clinical sites in approximately 12 patients with palpable breast cancers. Quality assurance and validation data (both clinical and non-clinical) obtained from these studies will support 510(k) regulatory filing for the BCL device. Positive margin rates associated with contemporary BCS are high (~22%-42%)9-13, and cause significant strains on patients and the cost of breast healthcare. Meta-analyses of the impact of surgical margins on local recurrence also confirm that negative margins have a positive prognostic effect. Thus, CairnSurgical is well positioned to explore and commercially develop a potentially practice-changing approach to BCS for accurate resection of breast cancers.