Dynamic ICG and FA Software

动态 ICG 和 FA 软件

• 批准号: 7933496
• 负责人: TIMOTHY J HOLMES
• 金额: $ 27.7万
• 依托单位: LICKENBROCK TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-05-01 至 2010-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7933496
• 关键词: Aftercare; Algorithms; Angiogenesis Inhibitors; Area; Avastin; Blood Vessels; Choroid; Clinic; Clinical; Computer software; Data Set; Detection; Diabetic Retinopathy; Disease; Dyes; Early Diagnosis; Eye; Fluorescein; Fluorescein Angiography; Fluoresceins; Fluorescent Dyes; Fundus; Image; Indocyanine Green; Injection of therapeutic agent; Lasers; Lesion; Maps; Marketing; Measurement; Measures; Medical Research; Methods; Modality; Motion; Output; Pharmaceutical Preparations; Pharmacotherapy; Phase; Process; Public Health; Research; Retina; Retinal; Sodium Fluorescein; Technology; Testing; Time; Tracer; bevacizumab; clinical application; design; graphical user interface; image processing; meetings; movie; neovascular; prototype; response

DESCRIPTION (provided by applicant): Indocyanine Green (ICG) and Sodium Fluorescein (SF) are fluorescent dyes used clinically in eye fundus imaging, primarily for detecting vascular abnormalities in the retina and choroid, which is the layer behind the retina. It is used with the Heidelberg Retinal Tomograph (HRT) by visualizing movies that show the dynamics of the dye filling and draining through the vessels, modalities called dynamic ICG (d-ICG) or dynamic Fluorescein Angiography (d-FA). It is proposed to develop a new software technology, leading to a software product, that will facilitate straightforward interpretation of d-ICG and d-FA movies. This Phase I proposal focuses, first, on an important clinical application - that of measuring the response of neovascular lesions to drug treatment, such as Avastin. An algorithm that provides a basic measurement of the filling time of blood vessels, maps that filling time over the area of the fundus, and highlights changes in the filling time following treatment, will be developed and tested for its ability to show changes after treatment. A second application is that of identifying feeder vessels, for the laser treatment of neovascular diseases. Several additional applications and algorithms are proposed and are identified as the subject of focus for later research, including the Phase II research. PUBLIC HEALTH SIGNIFICANCE: The end objective of this project is to produce technology that results in a software product for automatically analyzing dynamic Indocyanine Green (d-ICG) and Fluorescein (d-FA) angiographs. The Phase I project is aimed at showing feasibility of doing so, while the later Phase II project will be focused on building and testing the software to make it ready for integration into a product. There are many clinical and medical research applications for the software, including the measurement of response to drug treatments for neovascular conditions, the detection of feeder vessels for laser treatment of neovascular conditions, and the early detection of vascular changes that occur in diabetic retinopathy. Because of these many applications, there is a good potential market to make the end-product profitable. However, the Phase I and Phase II projects will be focused upon the application that is both (a), needed in the clinic and (b), possible to produce as a sellable product in a relatively short amount of time. The second requirement, (b), is critical because the time it takes to develop and sell a product must be short in order to produce cash flow necessary to deliver the product. To meet these 2 requirements, the first application of focus, and the most straightforward one to develop into a sellable product in a short time, will be in measuring the response to drug therapies. This product meets these two requirements partly because there is an immediate worldwide clinical and medical-research need for an objective measure of response to neovascular-disease drug therapies, data sets are readily available for testing the prototype software and our expertise equips us to assess, right away, the images output by the prototype product. The Phase I objective is to show that it is feasible to detect a response to drug therapy. If time permits, other applications will be shown to be feasible during Phase I as well. The specific aims are: (1) Design and implement algorithms for compensating the image sequences for motion and for measuring fill time. Fill time is the time that occurs between a reference instant (theoretically the instant of tracer injection, but this is difficult to determine so other reference points will be used) and the point where the pixel reaches 90% of its peak value. (2) Prototype a software algorithm that measures and displays changes in the fill time of blood vessels. (3) Prototype a graphical user interface (GUI) for executing the algorithm and interpreting the resulting measurements. (4) Test the algorithm for detecting response to treatment by processing image sets from a subject before and after treatment with Avastin/anti-VEGF, an anti-angiogenic drug. (5) Only if time permits, a related method for identifying feeder vessels in neovascular lesions will be prototyped.

描述（由申请人提供）：氨基氨基绿色（ICG）和荧光素（SF）是临床上临床中的荧光染料，主要用于检测视网膜和脉络膜中的血管异常，这是视网膜背后的层。它通过可视化显示染料填充和通过血管排干的电影，将其与海德堡视网膜断层扫描（HRT）一起使用，称为动态ICG（D-ICG）或动态荧光素血管造影（D-FA）。建议开发一种新的软件技术，从而导致软件产品，以促进对D-ICG和D-FA电影的直接解释。首先，该阶段的提案将重点放在重要的临床应用上 - 测量新生血管病变对药物治疗的反应，例如阿瓦斯汀。一种算法，可为血管的填充时间提供基本的测量，将填充眼底面积的时间填充时间的地图以及突出显示治疗后填充时间的变化，并测试其在治疗后显示出变化的能力。第二个应用是识别喂食器血管，用于对新血管疾病的激光治疗。提出了一些其他应用和算法，并被确定为以后研究的重点主题，包括第二阶段研究。公共卫生意义：该项目的最终目标是生产技术，以自动分析动态氨基氨基绿色（D-ICG）和荧光素（D-FA）血管造影的软件产品。第一阶段项目旨在显示这样做的可行性，而后来的II阶段项目将重点介绍构建和测试软件以使其为将其集成到产品中。该软件有许多临床和医学研究应用，包括测量对新血管疾病的药物治疗的反应，检测用于新生血管疾病的激光治疗的喂食器血管以及在糖尿病性视网膜病中发生的血管变化的早期检测。由于这些应用程序有很多应用，因此有良好的潜在市场可以使最终产品获利。但是，第一阶段和第二阶段项目将集中在诊所所需的（a）和（b）所需的应用上，可以在相对较短的时间内作为可销售产品生产。第二个要求（b）至关重要，因为开发和销售产品所需的时间必须很短，才能产生交付产品所需的现金流。为了满足这两个要求，重点的第一个应用以及在短时间内将最直接的产品应用于可销售的产品，将是衡量对药物疗法的反应。该产品符合这两个要求的部分原因是，全球临床和医学研究需要对新血管疾病疾病药物疗法的反应进行客观衡量，因此很容易获得数据集，可用于测试原型软件，我们的专业知识使我们能够评估原型产品的图像输出。第一阶段的目标是表明检测对药物治疗的反应是可行的。如果时间允许，其他应用程序也将在第一阶段中可行。具体目的是：（1）设计和实施用于补偿运动图像序列和测量填充时间的算法。填充时间是参考即时之间发生的时间（从理论上讲是示踪剂注入的瞬间，但这很难确定，因此将使用其他参考点），以及像素达到其峰值的90％的点。 （2）原型一种软件算法，该算法测量和显示血管填充时间的变化。 （3）原型图形用户界面（GUI），用于执行算法并解释所得的测量结果。 （4）通过处理抗血管生成药物Avastin/Anti-VEGF治疗前后的受试者的图像集测试算法是否检测对治疗的反应。 （5）只有在时间允许的情况下，一种相关的方法用于识别新血管病变中的喂食器血管。