vascuCAP: Non-invasive Computer-Aided Phenotyping of Vasculopathy

vascuCAP：血管病的非侵入性计算机辅助表型分析

• 批准号: 8981985
• 负责人: Andrew John Buckler
• 金额: $ 79.88万
• 依托单位: ELUCID
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8981985
• 关键词: Adoption; Animal Model; Animals; Appearance; Architecture; Arterial Fatty Streak; Arteries; Atherosclerosis; Autopsy; Biological Factors; Biological Markers; Blood; Blood Vessels; Boston; Cardiovascular Diseases; Carotid Arteries; Characteristics; Clinical; Clinical Chemistry; Collection; Complex; Computer Assisted; Coronary Arteriosclerosis; Coronary artery; Data; Data Set; Decision Making; Detection; Diagnosis; Diagnostic; Disease; Endarterectomy; Enrollment; Event; Feasibility Studies; Financial compensation; Goals; Histology; Human; Image; Image Analysis; Individual; Institutional Review Boards; Ionizing radiation; Lead; Lesion; Lipids; Louisiana; Magnetic Resonance Imaging; Manuals; Marketing; Measurement; Measures; Medical center; Methods; Modality; Monitor; Morphologic artifacts; Motion; Myocardial Infarction; Patients; Performance; Peripheral; Peripheral Vascular Diseases; Pharmaceutical Preparations; Phase; Phenotype; Pilot Projects; Preparation; Process; Provider; Research Personnel; Resolution; Severities; Site; Small Business Innovation Research Grant; Specimen; Speed; Stenosis; Stroke; Structure; Therapeutic; Time; Tissues; Translating; Translations; Ultrasonography; Universities; Vascular Diseases; Work; X-Ray Computed Tomography; base; bioimaging; care burden; computerized; drug development; femoral artery; imaging Segmentation; imaging biomarker; imaging modality; improved; member; novel therapeutics; personalized medicine; phase 2 study; prospective; public health relevance; quantitative imaging; response; spatiotemporal; success

 DESCRIPTION (provided by applicant): Vasculopathy encompasses a group of vascular diseases, which includes atherosclerosis, a major disease with enormous societal impact. Atherosclerosis is implicated in many cardiovascular diseases including myocardial infarction, peripheral vascular disease, and stroke. Approaches have been proposed for improving diagnostics, where inconclusive or misleading information can lead to under- and over-treatment. Additionally, better biomarkers are needed for use in developing more effective drugs for vasculopathies. Arterial stenosis as a biomarker is a poor predictor of events, yet it remains in common use. This burdens care providers with high misclassification rates. Detection of the so-called "vulnerable" plaque has demonstrated promise, but it is not without controversy and may be unlikely to achieve widespread adoption because it still relies on detecting one or a handful of "surrogate" features, that are based on limited autopsy studies. Elucid Bioimaging's vascuCAP (CAP stands for Computer Aided Phenotyping) processes magnetic resonance imaging (MRI) and/or computed tomography (CT), both of which are routinely used in vascular diagnostics. CAP aids the clinician with a multi-factorial quantitative imaging biomarker panel of specific, biologically-objective, and continuous-valued measurements such as distribution of lipid core and other determinants of lesion phenotype and severity. Recognizing the pros and cons of different imaging modalities with respect to any given patient's needs, vascuCAP is developed as a multi-modality analysis capability that maximizes the information content from whatever modality is available for that patient, whether CT (which is fast and generally leads to the most accurate measurements of structure but which utilizes ionizing radiation) or MR (which is currently most capable of measuring composition, avoids ionizing radiation, but takes more time to acquire). Our primary goal is to improve patient management by aiding therapeutic decision-making for both symptomatic and asymptomatic patients by combining the vascuCAP analysis of vascular imaging with the other objective patient data, i.e. clinical chemistry and other blood biomarkers. It may also be used to improve speed and efficiency in developing new therapeutics. We have recently completed feasibility studies in both animal models as well as human atherosclerosis that serve as the scientific rationale for the proposed study. This Phase II study will determine the MRI and CT characteristics of atherosclerotic plaques and compare them to reference truth standards including histopathological analyses of arterial endarterectomy specimens. We have established probable clinical utility in animal models as well as in human studies. This Phase II SBIR study will determine the degree to which vascuCAP analysis results, obtained in larger numbers of carotid and peripheral arteries, are similar to those obtained on ex-vivo histology and whether relevant reference measurements in the coronary arteries are in accordance with prior feasibility studies.

 描述（由申请人提供）：血管病涵盖一组血管疾病，其中包括动脉粥样硬化，这是一种具有巨大社会影响的主要疾病。动脉粥样硬化与许多心血管疾病有关，包括心肌梗塞、外周血管疾病和中风。改善诊断，其中不确定或误导性信息可能导致治疗不足和过度治疗。此外，需要更好的生物标志物来开发更有效的药物。动脉狭窄作为一种生物标志物对事件的预测效果较差，但它仍然被广泛使用，对所谓的“易损”斑块的检测已被证明是有希望的，但并非没有争议。并且可能不太可能获得广泛采用，因为它仍然依赖于检测一种或少数“替代”特征，这些特征基于有限的尸检研究 Elucid Bioimaging 的 vascuCAP（CAP 代表）。计算机辅助表型分析）处理磁共振成像 (MRI) 和/或计算机断层扫描 (CT)，这两种技术通常用于血管诊断，CAP 可以通过特定的、生物学客观的多因素定量成像生物标志物组来帮助临床医生。和连续值测量，例如脂质核心的分布和病变表型和严重程度的其他决定因素，根据任何特定患者的需求，vascuCAP 认识到不同成像方式的优缺点。被开发为一种多模态分析功能，可最大限度地提高患者可用的任何模态的信息内容，无论是 CT（速度快，通常可以实现最准确的结构测量，但利用电离辐射）还是 MR（目前最有能力测量成分，避免电离辐射，但需要更多时间来获取）我们的主要目标是通过将血管成像与 vascuCAP 分析相结合来帮助有症状和无症状患者的治疗决策，从而改善患者管理。其他客观的患者数据，即临床化学和其他血液生物标志物，也可用于提高开发新疗法的速度和效率。我们最近完成了动物模型和人类动脉粥样硬化的可行性研究，作为科学依据。这项 II 期研究将确定动脉粥样硬化斑块的 MRI 和 CT 特征，并将其与参考真实标准进行比较，包括动脉内膜切除术标本的组织病理学分析，我们已经在动物模型中建立了可能的临床实用性。这项 II 期 SBIR 研究将确定在大量颈动脉和外周动脉中获得的 vascuCAP 分析结果与体外组织学中获得的结果的相似程度，以及冠状动脉中是否有相关参考测量结果。动脉符合先前的可行性研究。