PATIENT-SPECIFIC NARROW BEAM BREAST CT

患者专用窄束乳房 CT

基本信息

批准号：
10540256
负责人：
Peymon Ghazi
金额：
$ 5.5万
依托单位：
MALCOVA LLC
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-02-28 至 2022-04-19
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10540256
关键词：
3-Dimensional Address Adopted Adoption Adult Affordable Care Act Age American Cancer Society American Medical Association Attention Back Bilateral Biopsy Breast Breast Cancer Detection Breast Magnetic Resonance Imaging Cancer Detection Cessation of life Chest wall structure Child Clinical Code Comprehensive Health Care Consumption Current Procedural Terminology Codes Development Devices Diagnosis Diagnostic Diagnostic Imaging Diagnostic Procedure Dose Equipment Europe FDA approved Germany Government Grant Growth Health Care Costs Health Care Reform Healthcare Hospitals Image Imaging Techniques Imaging technology Individual Industry Innovation Corps Insurance Investments Laws Left Legal patent Magnetic Resonance Imaging Malignant - descriptor Malignant Neoplasms Mammographic screening Mammography Manufacturer Name Marketing Mediation Medicaid Medical Medical center Modeling Nature Outcome Patients Phase Photons Physicians Population Preventive service Price Privatization Prognosis Protocols documentation Public Health Radiology Specialty Reporting Research Project Grants Resolution Roentgen Rays Scanning Screening procedure Sensitivity and Specificity Side Socioeconomic Status Subgroup System Technology Three-Dimensional Image Time Vendor Vision Woman Work X-Ray Computed Tomography analog base bilateral breast cancer breast density breast imaging cancer imaging cancer risk computer aided detection cost cost estimate density design detection sensitivity detector disease diagnosis experience falls imaging modality imaging platform imaging system individual patient insurance plan malignant breast neoplasm parent project prevent price lists programs prototype scale up screening stem success supplemental screening tomosynthesis trend analysis ultrasound

项目摘要

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.

执行摘要机会 - 乳腺癌是女性中最常见的恶性肿瘤，有多种技术可用于筛查。该疾病的诊断和诊断：乳房X线摄影、断层合成、超声波和MRI。不仅会给患者带来不适，而且其结果还取决于患者的乳房密度：乳房密度是与两种成像技术的检测灵敏度降低相关。超声波具有低分辨率，是高度用户化的。依赖，并且可能非常耗时； MRI 非常昂贵且耗时。因此，寻找一种能够解决当前筛查和诊断成像局限性的成像方式技术，优先考虑患者体验，并降低检测癌症的医疗保健成本。解决方案 - MALCOVA 设计并开发了专用乳腺 CT 系统的最小可行产品，该系统与乳房 MRI 类似，在 30 秒的扫描时间内，以乳房 X 线照相剂量水平提供两个乳房的 3D 图像，我们专有技术的科学前提是基于窄束 CT。图像采集 - Malcova 的专有技术受到两项已授予且完全拥有的实用专利的保护马尔科娃. 该 I-Corps 应用程序的父项目的具体目标是：目标 1：开发注量调制组件（该组件调节 X 射线的注量以生成窄光束），目标 2：开发线探测器组件（这会导致阻止散射光子的采集），以及目标 3：开发图像采集协议以及光束调制和线检测器组件的同步。在这些程序集之间实现同步可以证明解耦的概念，并澄清其未知因素第二阶段的龙门架开发，目前我们已经开发出了图像采集装置（见下图），并有望按时（2022 年 4 月底）完成该项目。 MALCOVA 的 MVP 概念如左所示，开发原型的照片如右。第一阶段项目完成后，我们开发的原型将能够使用在第二阶段，我们将重点关注患者床设计的优化，以促进最大程度的提高。胸壁覆盖和双侧乳房成像我们产品的最终愿景是同步双侧乳房。癌症成像平台为后续技术插件做好准备，例如集成活检、计算机辅助通过类似于断层合成设备的产品成本估算，我们的技术将是可使用放射设施，提供有效的筛查工具，特别是对于乳房致密的女性。