Computational Tools for Research in Neuroscience, Behavioral Science and Mental H

用于神经科学、行为科学和心理健康研究的计算工具

• 批准号: 8252547
• 负责人: GEORGE ZUBAL
• 金额: $ 78.01万
• 依托单位: MOLECULAR NEUROIMAGING, LLC
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-08-01 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8252547
• 关键词: Algorithms; Alzheimer' s Disease; Amyloid beta-Protein; Area; Behavioral Sciences; Biological Markers; Brain; Brain scan; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Clinics and Hospitals; Computer software; Corpus striatum structure; Data Set; Development; Diagnosis; Discipline of Nuclear Medicine; Disease Progression; Documentation; Evaluation; FDA approved; Generations; Goals; Housing; Human; Image; Image Analysis; Individual; MRI Scans; Manuals; Masks; Medical center; Methods; Monitor; Morbidity - disease rate; Neurologist; Neurosciences; Parkinson Disease; Patients; Pharmacologic Substance; Phase; Physicians; Positron-Emission Tomography; Process; Program Evaluation; Psyche structure; Radio; Reporting; Research; Scanning; Site; Slice; Societies; Solutions; Staging; Suggestion; Supervision; System; Testing; Texas; Tissues; Tracer; Training; Treatment Efficacy; Validation; Work; amyloid imaging; base; clinical application; computerized tools; diagnosis evaluation; disease diagnosis; dopamine transporter; follow-up; gray matter; image processing; improved; pre-clinical; prevent; programs; prospective; radioligand; radiotracer; research clinical testing; research study; single photon emission computed tomography; success; therapy development; tool

DESCRIPTION (provided by applicant): We propose to develop a software package to automatically evaluate a subject's beta amyloid PET scan (using either C11-PIB, F18-florbetaben, or F18-florbetapir, F18-flutemetamol) by normalizing the subject's scan, masking away non-gray matter tissue (without relying on co-registered MRI scans), placing standardized ROIs onto the transverse slices, and reporting SUVr values in separate brain areas referenced to the cerebellar gray matter. Our goal is that this analysis package ultimately would be FDA-510(k) approved and distributed to hospitals and clinics (and pharmaceutical companies), as a commercial product, to aid in the evaluation and diagnosis of patients. Through the use of such a validated and standardized analysis package, new radio-tracers can be objectively compared for their accuracy in quantitating beta amyloid in the brain, and more importantly, new therapies can be objectively and quantitatively evaluated for their efficacy in preventing or removing beta amyloid for each patient, on a personalized individual basis. An important portion of the testing, user interface evaluation, and ADER's report generation utility and clinical application will be conducted in a subaward under the supervision of Dr. Michael Devous within the Nuclear Medicine Center at the UT Southwestern Medical Center, Dallas, Texas. At MNI, New Haven, we will continue to test and evaluate ADER in house within our Radio-tracer Evaluation Program (RTEP) program, where we continue to test potential new beta amyloid PET and SPECT imaging agents, while clinically evaluating subjects by our in-house neurologists and support staff. The potential benefit to society is considerable since an ADER analysis package would provide a quantitative biomarker analysis method for Alzheimer's disease progression for individualized therapy efficacy. Alzheimer's disease (AD) is associated with significant morbidity and a useful marker and/or brain scan analysis package, like this proposed ADER, would add to our understanding of AD disease progression and provide objective assessment of neuroprotective and restorative therapies. This fully automated image processing will also allow for fewer subjects to be studied (with the same clinical power) in clinical trials using new PET and SPECT radioligands. As new tracers and therapies are developed, ADER would co-evolve with these studies into an optimized image analysis method for diagnosing, staging and treating Alzheimer's disease. PUBLIC HEALTH RELEVANCE: Evaluation of Radiotracers (ADER) Project Narrative We propose to develop an automated package for analysis of beta-amyloid accumulation in Alzheimer's patients' brains which can be easily implemented by pharmaceutical companies for therapeutic drug discovery, as well as in a clinical setting, for high quality quantitative PET (and SPECT) imaging assessments. This analysis will remove subjectivity in the determination of the imaging outcome measure and permit a reproducible evaluation of new Alzheimer's radio- tracers' imaging potential. ADER can be used to test the efficacy of new Alzheimer's therapies in which FDA Phase II tested radiotracers are used as surrogate biomarkers. Our validated image processing package is highly relevant to the ongoing search for new diagnostics and treatments since it will serve as a new "medical device" (as defined by the FDA), which will improve the way in which medical care is delivered to Alzheimer's patients.

描述(由申请人提供)：我们建议开发一个软件包来自动评估受试者的β淀粉样蛋白PET扫描(使用C11-PIB，F18-florbetaben，或F18-florbetapir，F18-floretamol)，方法是使受试者的扫描正常化，遮盖非灰质组织(不依赖于共同注册的MRI扫描)，将标准化的ROI放置在横切片上，并报告参考小脑灰质的不同大脑区域的SUVR值。我们的目标是，该分析包最终将获得FDA-510(K)批准，并作为商业产品分发给医院和诊所(以及制药公司)，以帮助评估和诊断患者。通过使用这种经过验证和标准化的分析包，可以客观地比较新的放射性示踪剂在定量大脑中β淀粉样蛋白方面的准确性，更重要的是，可以根据个人情况客观和定量地评估新疗法在预防或消除每个患者的β淀粉样蛋白方面的效果。测试、用户界面评估、ADER报告生成实用程序和临床应用的重要部分将在德克萨斯州达拉斯德克萨斯州大学西南医学中心核医学中心内的Michael Devous博士监督下进行。在纽黑文的MNI，我们将继续在我们的无线电示踪评估计划(RTEP)计划中对ADER进行内部测试和评估，我们将继续测试潜在的新型β-淀粉样蛋白PET和SPECT显像剂，同时由我们内部的神经学家和支持人员对受试者进行临床评估。这对社会的潜在益处是相当大的，因为ADER分析包将为阿尔茨海默病的个体化治疗效果提供一种定量的生物标记物分析方法。阿尔茨海默病(AD)与显著的发病率有关，一个有用的标志物和/或脑扫描分析包，如建议的ADE，将增加我们对AD疾病进展的了解，并为神经保护和恢复性治疗提供客观评估。这种完全自动化的图像处理还将允许在使用新的PET和SPECT放射性配基的临床试验中研究更少的受试者(具有相同的临床能力)。随着新的示踪剂和治疗方法的开发，ADER将与这些研究共同演变为诊断、分期和治疗阿尔茨海默病的优化图像分析方法。 公共卫生相关性：放射性示踪剂的评估(ADER)项目描述我们建议开发一个用于分析阿尔茨海默氏症患者大脑中β-淀粉样蛋白积聚的自动化包，该包可以很容易地由制药公司实施，用于治疗药物的发现，以及在临床环境中，用于高质量的定量PET(和SPECT)成像评估。这一分析将消除确定成像结果测量的主观性，并允许对新的阿尔茨海默氏症放射性示踪剂的成像潜力进行可重复性的评估。ADER可用于测试新的阿尔茨海默氏症治疗方法的有效性，在该方法中，FDA第二阶段测试的放射性示踪剂被用作替代生物标记物。我们经过验证的图像处理包与正在进行的新诊断和治疗方法的搜索高度相关，因为它将作为一种新的“医疗设备”(根据FDA的定义)，这将改善向阿尔茨海默氏症患者提供医疗护理的方式。