A Rapid Carotid Atherosclerotic Disease Assessment System with 3D MRI

具有 3D MRI 的颈动脉粥样硬化疾病快速评估系统

• 批准号: 10383271
• 负责人: Dongxiang Xu
• 金额: $ 24.98万
• 依托单位: IMAGING BIOMARKER SOLUTIONS, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-15 至 2023-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10383271
• 关键词: 3-Dimensional; Adoption; Agreement; Anatomy; Angiography; Area; Arterial Fatty Streak; Bilateral; Carotid Arteries; Carotid Atherosclerotic Disease; Cause of Death; Classification; Clinical; Complex; Computer software; Cost efficiency; Data Analyses; Deductibles; Detection; Development; Diagnosis; Diagnostic; Ensure; Equilibrium; Etiology; Evaluation; Event; Goals; Guidelines; Hemorrhage; Image; Imaging Techniques; Imaging technology; Ischemic Stroke; Lesion; Magnetic Resonance Imaging; Measurement; Motion; Names; Output; Patient imaging; Patients; Performance; Phase; Play; Protocols documentation; Publishing; Quality of life; Reader; Reporting; Research Project Grants; Risk; Role; Rupture; Scanning; Site; Stenosis; Stroke; Stroke prevention; Surface; System; Systems Analysis; Techniques; Technology; Testing; Thick; Time; TimeLine; Training; United States; Validation; X-Ray Computed Tomography; accurate diagnosis; automated analysis; base; clinical application; clinical imaging; contrast imaging; cost; cost estimate; cryptogenic stroke; deep learning; design; disability; effective therapy; experience; improved; innovation; novel; patient subsets; product development; prototype; radiologist; research study; software development; stroke risk; tool; ultrasound

Abstract Stroke is a major cause of death and long-term disability worldwide. In the United States alone, there are roughly 0.8 million ischemic strokes each year, with an estimated cost of $34 billion. Among the various etiologies of stroke, carotid atherosclerotic disease (CAD) is a very common one. Accurate diagnosis of CAD will be important for effective treatment and prevention of stroke. Although carotid vessel wall (CVW) magnetic resonance imaging (MRI) has shown superior advantages in CAD assessment over other imaging techniques (e.g. ultrasound, CTA, etc.), its widespread in clinical use is slow due to several limitations, including lengthy and complex imaging procedure, highly demanding on technologists’ training and experiences and laborious lesion analysis, etc. Therefore, there is a clear need for a fast and automated image acquisition and analysis solution to improve the adoption in clinical settings. In this Phase I project, we plan to develop a rapid clinical CAD assessment solution, which includes a large coverage single contrast MR imaging procedure and a fully automated analysis software, named CASCADIA, with innovative image quality evaluation (IQE) and deep learning lesion analysis technologies. We also designed a new domain adaptation framework to ensure CASCADIA’s performance on images acquired from various imaging sites. This system is expected to complete clinical CAD assessment of a patient with unprecedented short time of 5 minutes which is 1/10 of the time in current clinical use. This solution will not only be an efficient assistant diagnosis tool for clinicians but also benefit patients with shorter imaging time and potential cost deduction. The output of Phase I product will include image quality evaluation, clinical measurements and atherosclerotic lesion classification. Development of more advanced analysis, such as lesion characterization and risk score, are planned in Phase II. We currently have access to more than 1000 3DMERGE scans acquired from previous research projects (a large portion of them with radiologists’ annotations), with which, in Phase I, we propose to: Aim 1: Develop the prototype software of CASCADIA, which includes: 1) Develop a streamlined CAD assessment workflow by combining IQE and lesion classification modules 2) Integrate clinical measurement functions, including stenosis, plaque burden and wall thickness Aim 2: Evaluate performance of the prototype software, which includes: 1) Evaluate the performance of IQE and lesion classification modules in CASCADIA 2) Install the proposed solution in a clinical imaging site and test with phantom This Phase I proposal is planned for six months with clearly defined timeline and milestones. The developed prototype will be deployed in clinical settings as a pre-market base for our long-term goal of full- scale commercial product development in a Phase II application.

摘要 中风是世界范围内导致死亡和长期残疾的主要原因。仅在美国，就有 每年大约有80万例缺血性中风，估计成本为340亿美元。在众多的 卒中的病因中，颈动脉粥样硬化性疾病(CAD)是一种非常常见的疾病。CAD的准确诊断 对有效治疗和预防中风具有重要意义。尽管颈动脉管壁(CVW) 磁共振成像(MRI)在冠心病评估中显示出比其他成像更优越的优势 技术(例如超声、CTA等)，其在临床上的广泛应用由于几个限制而缓慢， 包括冗长复杂的成像程序，对技术人员的培训要求很高，以及 经验和繁琐的病变分析等。因此，显然需要一种快速和自动化的 图像采集和分析解决方案，以提高临床环境中的采用率。 在这个第一阶段的项目中，我们计划开发一个快速的临床CAD评估解决方案，其中包括一个大型 覆盖单对比磁共振成像程序和名为Cascadia的全自动分析软件， 具有创新的图像质量评估(IQE)和深度学习病变分析技术。我们也 设计了一种新的领域适配框架，以确保Cascadia在从 不同的成像地点。该系统有望完成临床CAD评估的患者 前所未有的短时间为5分钟，是目前临床使用时间的1/10。此解决方案不会 不仅是临床医生的一种有效的辅助诊断工具，而且使患者受益于更短的成像时间和 潜在的成本扣除。 第一阶段产品的输出将包括图像质量评估、临床测量和 动脉粥样硬化病变分类。开发更高级的分析，如病变特征 和风险评分，计划在第二阶段进行。 我们目前可以访问从以前的研究项目(A)获得的1000多个3DMERGE扫描 其中很大一部分带有放射科医生的注释)，在第一阶段，我们建议： 目标1：开发卡斯卡迪亚原型软件，包括： 1)结合IQE和病变分类模块，开发简化的CAD评估工作流程 2)集成临床测量功能，包括狭窄程度、斑块负荷和壁厚 目标2：评估原型软件的性能，包括： 1)评估Cascadia中IQE和病变分类模块的性能 2)将建议的解决方案安装在临床成像站点并使用体模进行测试 这项第一阶段提案计划为期六个月，并有明确的时间表和里程碑。这个 开发的原型将部署在临床环境中，作为我们全面 在第二阶段应用程序中扩展商业产品开发。