PATIENT-SPECIFIC NARROW BEAM BREAST CT

执行摘要 机遇--乳腺癌是女性最常见的恶性肿瘤。有几种技术可用于筛选 以及本病的诊断：乳房X光摄影、断层合成、超声和核磁共振。乳房X线摄影与断层合成 不仅会给患者带来不适，他们的结局也取决于患者的乳房密度：乳房密度是 与两种成像技术中检测灵敏度降低相关。超声波具有低分辨率，高度易用性- 依赖，而且可能很耗时；核磁共振费用高得令人望而却步，而且很耗时。有很大的需求， 因此，对于解决当前筛查和诊断成像的局限性的成像模式 技术，优先考虑患者体验，并降低检测癌症的医疗成本。 解决方案-MALCOVA设计和开发了一种专用乳房CT系统的最低可行产品 提供双侧乳房的3D图像，类似于乳房MRI，在30秒的扫描时间内，以乳房X光照相剂量水平， 而不进行乳房按压。我们专利技术的科学前提是基于窄束CT 图像获取-马尔科瓦的专有技术受到两项实用程序专利的保护，这两项专利已经授予并完全拥有 马尔科瓦写的。 I-Corps应用程序的父项目的具体目标是：目标1：开发磁通调制组件 (该组件调制X射线的通量以产生窄光束)，目标2：开发一种线探测器组件 (导致防止获取散射光子)和目标3：制定图像获取协议 以及光束调制和线检测器组件的同步。 实现这些程序集之间的同步提供了分离的概念的证明，并澄清了未知数 到目前为止，我们已经开发出了图像采集设备(见下图)，以及 正在按部就班地按时完成项目(到2022年4月底)。 MALCOVA的MVP。概念图显示在左侧，开发的原型照片显示在右侧。 在这个第一阶段项目完成后，我们开发的原型将能够用一个 窄波束设计范例。在第二阶段，我们将专注于优化患者表设计，以促进最大限度地 胸壁覆盖和双侧乳房成像。我们产品的最终愿景是同时进行双侧乳房 癌症成像平台为后续技术插件做好准备，如集成活检、计算机辅助 检测和诊断。随着产品成本估计类似于断层合成单元，我们的技术将是 可由放射科机构使用，为乳房致密的妇女提供了一种有效的筛查工具。

Executive Summary Opportunity - Breast cancer is the most common malignancy among women. Several technologies are used for screening and diagnosis of this disease: Mammography, Tomosynthesis, Ultrasound, and MRI. Mammography and Tomosynthesis not only cause discomfort to patients, but their outcome is also dependent on the patient’s breast density: breast density is associated with reduced detection sensitivity in both imaging techniques. Ultrasound has a low-resolution, is highly user- dependent, and can be time-consuming; MRI is prohibitively expensive and time-consuming. There is significant need, therefore, for an imaging modality that addresses the limitations of the current screening and diagnostic imaging technologies, prioritizes patient experience, and reduces health care costs of detecting cancer. Solution - MALCOVA has designed and developed a minimum viable product of a Dedicated Breast CT system that provides 3D images of both breasts, similar to breast MRI, in 30 seconds of scan time, at mammographic dose levels, without applying breast compression. The scientific premise of our proprietary technology is based on narrow-beam CT image acquisition - Malcova’s proprietary technology protected through two utility patents, already granted and fully owned by Malcova. The specific aims for the parent project of this I-Corps application are: Aim 1: Development of fluence modulation assembly (this assembly modulates the fluence of x-rays to generate a narrow beam), Aim 2: Development of a line detector assembly (which leads to preventing the acquisition of scattered photons), and Aim 3: Development of the image acquisition protocol and synchronization of the beam modulation and line detector assemblies. Achieving synchrony between these assemblies renders proof of concept of, and clarifies the unknowns for, decoupled gantry development in Phase 2. So far, we have developed the image acquisition apparatus (see the following figure), and are on track to finish the project on time (by the end of April 2022). MALCOVA’s MVP. The concept is shown in left, with the photos of the developed prototype on right. Upon completion of this Phase 1 project, our developed prototype will be capable of scanning a breast-like object with a narrow beam design paradigm. In Phase 2, we will focus on optimization of a patient-table design to facilitate maximal chest wall coverage and bilateral breast imaging. The final vision for our product is a simultaneous bilateral breast cancer imaging platform ready for subsequent technology plug-ins such as integrated biopsy, computer aided detection and diagnosis. With a product cost estimate akin to that of a Tomosynthesis unit, our technology will be accessible to radiologic facilities, providing an effective screening tool, in particular, for women with dense breasts.