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）：吲哚菁绿（ICG）和荧光素钠（SF）是临床上用于眼底成像的荧光染料，主要用于检测视网膜和脉络膜（视网膜后面的层）的血管异常。它与海德堡视网膜断层扫描仪 (HRT) 配合使用，通过可视化影片显示染料填充和排出血管的动态，这种模式称为动态 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，从而开发出一种软件产品，该产品将有助于直接解释 d-ICG 和 d-FA 电影。该一期提案首先侧重于一项重要的临床应用——测量新生血管病变对药物治疗（如阿瓦斯丁）的反应。将开发一种算法，提供血管充盈时间的基本测量，绘制眼底区域的充盈时间图，并突出显示治疗后充盈时间的变化，并测试其显示治疗后变化的能力。第二个应用是识别供给血管，用于激光治疗新生血管疾病。提出了一些额外的应用程序和算法，并被确定为后续研究的重点主题，包括第二阶段研究。公共健康意义：该项目的最终目标是开发一种技术，开发出一种软件产品，用于自动分析动态吲哚菁绿 (d-ICG) 和荧光素 (d-FA) 血管造影照片。第一阶段项目旨在展示这样做的可行性，而后来的第二阶段项目将侧重于构建和测试软件，以便为集成到产品中做好准备。该软件有许多临床和医学研究应用，包括测量新生血管疾病药物治疗的反应、检测激光治疗新生血管疾病的供给血管，以及早期检测糖尿病视网膜病变中发生的血管变化。由于应用范围广泛，最终产品具有良好的潜在市场盈利能力。然而，第一阶段和第二阶段项目将重点关注以下应用：(a) 临床所需，(b) 可以在相对较短的时间内生产为可销售产品。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，焦点的第一个应用，也是在短时间内开发成可销售产品的最直接的应用，将是测量对药物治疗的反应。该产品满足这两个要求，部分原因是全球范围内的临床和医学研究迫切需要对新生血管疾病药物治疗的反应进行客观测量，数据集可随时用于测试原型软件，并且我们的专业知识使我们能够评估，马上，原型产品输出的图像。第一阶段的目标是证明检测药物治疗的反应是可行的。如果时间允许，其他应用也将在第一阶段被证明是可行的。具体目标是： (1) 设计和实现用于补偿运动图像序列和测量填充时间的算法。填充时间是指参考时刻（理论上是示踪剂注入的时刻，但这很难确定，因此将使用其他参考点）和像素达到其峰值的 90% 的点之间发生的时间。 (2) 建立测量和显示血管填充时间变化的软件算法原型。 (3) 建立图形用户界面 (GUI) 原型，用于执行算法并解释测量结果。 (4) 通过处理受试者在使用阿瓦斯汀/抗 VEGF（一种抗血管生成药物）治疗之前和之后的图像集来测试检测治疗反应的算法。 (5) 只有在时间允许的情况下，才会原型设计一种识别新生血管病变中的供血血管的相关方法。