Breast Cancer Locator

乳腺癌定位器

• 批准号: 9531309
• 负责人: Venkataramanan Krishnaswamy
• 金额: $ 96.99万
• 依托单位: CAIRNSURGICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-01 至 2020-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9531309
• 关键词: 3D Print; Anterior; Breast; Breast-Conserving Surgery; Chest wall structure; Clinical; Clinical Research; Clinical Trials; Collaborations; Complex; Computer software; Computers; Cost Analysis; Cues; Data; Data Analyses; Development; Devices; Distant; Dyes; Enrollment; Excision; Funding; Future; Health Care Costs; Healthcare; Image; Injections; Ink; Institution; Investments; Localized Malignant Neoplasm; Location; Magnetic Resonance Imaging; Malignant Neoplasms; Mammary Gland Parenchyma; Marketing; Medical; Meta-Analysis; Modeling; Multi-Institutional Clinical Trial; Operative Surgical Procedures; Optics; Pain; Palpable; Patients; Performance; Phase; Positioning Attribute; Preclinical Testing; Preparation; Printing; Procedures; Process; Production; Progress Reports; Randomized; Recurrence; Research Infrastructure; Research Personnel; Resected; Scanning; Schedule; Series; Site; Specific qualifier value; Sterilization; Supination; Surface; Surgeon; Surgical incisions; Surgical margins; System; Technology; Testing; Time; Training; United States National Institutes of Health; Validation; arm; base; clinical research site; commercialization; cost; experience; image guided; image guided intervention; improved; innovation; interstitial; malignant breast neoplasm; manufacturing scale-up; novel therapeutics; phase 2 study; process optimization; prognostic; quality assurance; software development; standard of care; success; surgery outcome; tumor

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.

项目摘要/摘要： 达特茅斯的一家剥离公司--凯恩外科有限责任公司将优化和测试一种 新型影像引导介入装置--乳腺癌定位仪在保乳手术中的应用 为了(1)消除导线本地化--这是一种相当有效、有些昂贵而且肯定不方便的程序 对于患者和外科医生--同时(Ii)减少切缘阳性率和随后的再次切除 手术--这不仅给病人带来了巨大但不必要的负担，也增加了医疗成本。 具体地说，BCL是一种针对患者的3D打印设备，允许在临床上准确传输多个 通过目前可用的其他竞争技术无法获得的手术线索，包括：i)肿瘤 从切口处看投射在乳房表面的轮廓，ii)术中放置的钢丝 这定义了从切开部位到肿瘤的直接路径，III)最大肿瘤范围的间质墨迹 使用创新的入口系统，以及从肿瘤前缘到乳房表面的距离 肿瘤后缘至胸壁。在拟议的第二阶段研究中，凯恩外科公司将合作 与达特茅斯研究人员和四家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求来提高处理效率，并在10- 达特茅斯的患者研究，2)开发BCLPlanner软件以简化BCL的创建和质量保证 流程，并优化BCL的生产、包装和交付，以实现制造和规模化 以及3)在大约12名患者中测试BCL在四个遥远的临床地点的可行性。 明显的乳腺癌。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设备的510(K)监管申报。与以下各项相关的正利润率 当代的BCS很高(~22%-42%)9-13，对患者和乳房成本造成显著的压力 医疗保健。手术切缘对局部复发影响的荟萃分析也证实了阴性 利润率对预后有积极的预测作用。因此，凯恩外科公司处于有利的地位，可以进行探索和商业 开发一种可能改变实践的BCS方法，用于准确切除乳腺癌。