Supine Breast MRI Standardization for Breast Cancer Locator

项目摘要/摘要： 从达特茅斯分拆出来的凯恩外科公司将对仰卧位乳房磁共振成像进行标准化，以简化专业人员的工作流程。 乳腺癌定位器(BCL)在乳腺癌保乳中的应用 手术(BCS)：(I)消除钢丝定位--一种中等有效、有点昂贵和肯定 给患者和外科医生带来不便的程序--同时(Ii)降低阳性切缘率和 随后的再次切除手术-这不仅是患者的重大负担，也是不必要的负担 医疗保健成本。具体地说，仰卧位乳腺mri的标准化将通过a)优化来实现。 和使用用于乳房成像的标准身体线圈，b)开发和测试身体线圈放置平台- 形式，以最大限度地减少乳房变形和成像期间的位置不一致，以及c)开发和 可添加到俯卧位乳房检查或使用的简略仰卧位乳房MRI检查方案的测试 独立的。在拟议的第一阶段和第二阶段(快速通道)临床研究中，凯恩外科公司将与 达特茅斯大学的研究人员和合作机构的临床医生测试可调整的身体线圈放置方式 在一项有限的研究中对12名志愿者进行了有限的研究，这些志愿者在MRI扫描中使用了不同大小的乳房 供应商2)使用可生产版本的身体线圈放置平台对62名患者进行研究，以 建立简略仰卧位乳腺MRI方案的可行性，作为标准护理的附加程序 乳腺癌患者的俯卧位磁共振成像，以及3)评估身体线圈放置平台在乳腺癌患者中的疗效 涉及远程临床合作地点的有限多中心研究。凯恩外科也将开发和临床 验证从医院高效传输医学图像所需的信息技术(IT)基础设施 用于支持BCL生产、管理工单和生成独特患者的服务器 确保患者匹配的BCL设备的可追踪性的标识符，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 从这些研究中获得的非临床)将支持身体线圈支撑平台的510(K)监管申报 作为BCL装置的附件。当代BCS的正利润率很高(~22%- 42%)9-13，并对患者造成重大压力并增加乳房保健成本。元分析的研究成果 手术切缘对局部复发的影响也证实切缘阴性有积极的预后。 效果。因此，凯恩外科公司处于有利地位，可以开发一种潜在的改变实践的方法并将其商业化 BCS在乳腺癌精确切除中的应用

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.