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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.

执行摘要乳腺癌是女性中最常见的恶性肿瘤。几种技术用于筛选乳腺X线摄影、断层合成摄影、超声和MRI。乳腺X射线摄影和断层合成摄影不仅会给患者带来不适，而且其结果还取决于患者的乳腺密度：乳腺密度这与两种成像技术中检测灵敏度的降低有关。超声波的分辨率很低，依赖性，并且可能是耗时的; MRI非常昂贵和耗时。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设计并开发了一种最小可行产品，即专用乳腺CT系统，提供两个乳房的3D图像，类似于乳房MRI，在30秒的扫描时间内，在乳房摄影剂量水平下，而不进行乳房压迫。我们专有技术的科学前提是基于窄束CT 图像采集- Malcova的专有技术通过两项实用专利得到保护，这两项专利已经授予并完全拥有通过Malcova。本I-Corps应用程序的母项目的具体目标是：目标1：开发注量调制组件 (this目标2：开发线探测器组件目标3：制定图像采集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解耦概念的证明，并澄清了解耦的未知因素第二阶段的龙门架开发。到目前为止，我们已经开发了图像采集装置（见下图），我们将按时完成项目（到2022年4月底）。马尔科瓦的MVP左边是概念图，右边是开发原型的照片。在第一阶段项目完成后，我们开发的原型将能够扫描乳房状物体，窄波束设计范例。在第2阶段，我们将重点关注患者检查床设计的优化，以促进最大的胸壁覆盖和双侧乳房成像。我们产品的最终愿景是同时双侧乳房癌症成像平台可用于后续技术插件，如集成活检、计算机辅助检测和诊断。由于产品成本估算类似于断层合成装置，我们的技术将可利用放射设施，提供有效的筛查工具，特别是对乳房致密的妇女。