Supine Breast MRI Standardization for Breast Cancer Locator

项目总结/摘要： CairnSurgical，Inc.，一家达特茅斯的分拆公司，将标准化仰卧乳房MRI，以简化亲， 乳腺癌定位仪（BCL）在保乳手术中的应用 手术（BCS），以（i）消除导丝定位-一种适度有效，有点昂贵， 对于患者和外科医生来说不方便的手术-并且伴随着（ii）降低阳性切缘率， 随后的再次切除手术-不仅对患者而且对患者都是一个重大但不必要的负担。 医疗费用。具体而言，仰卧位乳腺MRI的标准化将通过a）优化 和使用标准体线圈进行乳房成像，B）体线圈放置平台的开发和测试， 形成以最小化成像期间乳房变形和定位不一致，以及c）显影和 测试简化的仰卧乳房MRI方案，可添加到俯卧乳房检查中或使用 独立地。在拟议的I期和II期（快速通道）临床研究中，CairnSurgical将与 合作机构的达特茅斯研究人员和临床医生1）测试可调节的体线圈放置 在12名志愿者的有限研究中，使用不同乳房杯尺寸的MRI扫描仪， 供应商2）使用体线圈放置平台的生产就绪版本进行62例患者研究， 确立简化仰卧位乳腺MRI方案作为标准治疗附加程序的可行性 乳腺癌患者的俯卧MRI，以及3）评价体线圈放置平台在乳腺癌患者中的有效性。 涉及远程临床合作研究中心的有限多中心研究。CairnSurgical还将开发和临床应用 验证从医院有效传输医学图像所需的信息技术（IT）基础设施 CairnSurgical的服务器，以实现BCL生产，管理工作订单并生成独特的患者 标识符，以确保患者匹配BCL器械的可追溯性，这对广泛的临床应用至关重要。 BCL设备的采用和商业成功。质量保证和验证数据（临床和 非临床）将支持体线圈支撑平台的510（k）监管申报 作为BCL装置的附件。与当代BCS相关的阳性边缘率很高（~22%- 42%）9-13岁，并对患者造成重大压力和乳腺保健费用。荟萃分析 手术切缘对局部复发影响也证实切缘阴性有积极的预后 效果因此，CairnSurgical处于有利地位，可以开发和商业化一种可能改变实践的 乳腺癌精确切除的BCS方法。

PROJECT SUMMARY/ABSTRACT: CairnSurgical, Inc., a Dartmouth spin-off company, will standardize supine breast MRI to streamline pro- duction of the Breast Cancer Locator (BCL) as a cancer localization device for use 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, standardization of supine breast MRI will be achieved through a) optimization and use of standard body coils for breast imaging, b) development and testing of a body coil placement plat- form to minimize breast deformation and positioning inconsistencies during imaging, and c) development and testing of an abbreviated supine breast MRI protocol that can be added to a prone breast exam or used independently. In the proposed Phase I and II (Fast Track) clinical studies, CairnSurgical will collaborate with Dartmouth researchers and clinicians at partnering institutions to 1) test an adjustable body coil placement platform in a limited study of 12 volunteers with varying breast cup sizes in MRI scanners from multiple vendors 2) conduct a 62-patient study with a production-ready version of the body coil placement platform to establish the viability of an abbreviated supine breast MRI protocol as an add-on procedure to standard-of-care prone MRI in breast cancer patients, and 3) evaluate the efficacy of the body coil placement platform in a limited multi-center study involving remote clinical partnering sites. CairnSurgical will also develop and clinically validate information technology (IT) infrastructure required for efficient transfer of medical images from hospital servers to CairnSurgical to enable BCL production, manage work orders and generate unique patient identifiers to ensure traceability of the patient-matched BCL devices, which are critical to widespread clinical adoption and commercial success of the BCL device. Quality assurance and validation data (both clinical and non-clinical) obtained from these studies will support 510(k) regulatory filing for the body coil support platform as an accessory to 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 develop and commercialize a potentially practice-changing approach to BCS for accurate resection of breast cancers.