Robust BCT for Clinical Use - Phase II

用于临床的稳健 BCT - II 期

• 批准号: 9071300
• 负责人: David Kopperdahl
• 金额: $ 60万
• 依托单位: O. N. DIAGNOSTICS, LLC
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-08-01 至 2018-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9071300
• 关键词: Abdomen; Address; Age; Aging; American; Back Pain; Biomechanics; Bone Density; Businesses; Calibration; Chronic Kidney Failure; Classification; Clinical; Clinical Research; Clinical Trials; Computed Tomographic Colonography; Computer software; Cost Effectiveness Analysis; Data Set; Densitometry; Detection; Development; Device or Instrument Development; Diabetes Mellitus; Diagnosis; Diagnostic; Diagnostic tests; Diffusion; Dose; Dual-Energy X-Ray Absorptiometry; Early identification; Economic Burden; Elderly; Finite Element Analysis; Fracture; Framingham Heart Study; Goals; Growth; Guide prevention; Guidelines; Health; Healthcare; Hip Fractures; Hip region structure; Image; Image Analysis; Individual; Inflammatory Bowel Diseases; Intravenous; Legal patent; Longitudinal Studies; Low Dose Radiation; Lung; Lung CAT Scan; Manuals; Marketing; Measurement; Measures; Medical; Medical Device; Methods; Monitor; National Institute of Arthritis and Musculoskeletal and Skin Diseases; Osteoporosis; Osteoporotic; Outcome; Patient risk; Patients; Pelvis; Performance; Phase; Physicians; Population; Prevalence; Preventive care; Preventive treatment; Process; Protocols documentation; Public Health; Radiation; Recording of previous events; Reporting; Research; Research Infrastructure; Risk; Roentgen Rays; Scanning; Small Business Innovation Research Grant; Smoker; Smoking; Societies; Source; Spinal Fractures; Staging; Stress Tests; Techniques; Technology; Testing; Translating; Translations; Venous; Vertebral column; Woman; Work; X-Ray Computed Tomography; abdominal CT; aged; base; bone; bone health; bone mass; bone strength; clinical Diagnosis; clinical practice; clinically significant; cohort; cost; cost effective; cost effectiveness; economic value; health economics; high risk; image processing; improved; lung cancer screening; malignant breast neoplasm; meetings; men; mortality; novel; osteoporosis with pathological fracture; patient population; primary outcome; product development; quality assurance; reconstruction; research study; screening; software development; spine bone structure; time interval; tool; virtual

DESCRIPTION (provided by applicant): Osteoporosis is a major public health threat for over 50% of the population over age 50, with over 10 million Americans estimated to have osteoporosis and another 34 million at increased risk due to low bone mass. Additionally, over 340,000 osteoporotic hip and 700,000 spine fractures are reported annually in patients over age 65. Despite the clinical importance of osteoporosis, it is under-diagnosed and under-treated with only 12- 14% of those who need testing receiving it. To rectify this, O.N. Diagnostics has developed "ancillary BCT" for clinical use. BCT combines image processing of CT scans, bone biomechanics, and finite element analysis to provide estimates of BMD and whole-bone strength from patient CT scans. The goal of this SBIR project is to develop the ability to provide these BMD and bone strength measures using a wide range of typical clinical CT exams, in which the BCT analysis is performed as an "add-on" analysis to a CT exam that was ordered for a non-osteoporosis indication, thereby enabling the identification of those patients at high risk o hip and spine fracture while removing the patient inconvenience of undergoing a dedicated osteoporosis scan and maximizing the cost-effectiveness of pre-existing imaging exams. We estimate that up to 8-10 million CT scans taken each year in the U.S. contain the hip or spine and would be technically suitable for ancillary BCT analysis. Our plan is to offer ancillary BCT to those CT patients who meet the current clinical criteria to have a DXA exam but who have not yet had a DXA. In Phase-I of this project, we successfully developed software (VirtuOst®) to assess both bone strength and BMD using previously acquired clinical CT scans. This Phase-II project will focus on the remaining technical challenges to the full clinical implementation of ancillary BCT. In Aim 1, we will improve throughput and reliability by automating image processing steps and integrating automatic quality assurance testing into the analysis workflow, eliminating the procedural overhead associated with an analysis and reducing the cost to no more than that of a DXA exam. Utilizing existing image processing steps we will add vertebral facture assessment to add value to BCT. In Aim 2 we will optimize our phantomless calibration technique using patient-specific estimates of x-ray beam energy that will allow repeatable BCT result regardless of CT scanner or acquisition protocol. We will extend BCT analysis to the 50% of abdominal CT exams acquired with intravenous contrast, and address monitoring guidelines for ancillary BCT. Finally, in Aim 4, we will integrate all these advances into a clinical study featuring multiple CT scanners and exam types acquired from a large and demographically diverse patient population. Focusing on clinical translation, we will also perform a cost-effectiveness analysis to determine the most efficient exam types to analyze and which patients would benefit most from ancillary BCT from a health economics perspective. At the end of this SBIR study, we will have expanded the scope and clinical utility of ancillary BCT analysis to at risk patients without DXA exams but with existing CT exams and determined which of these patients BCT will benefit most.

描述（由适用提供）：骨质疏松症是50岁以上50％以上人口的主要公共卫生威胁，估计有超过1000万美国人患有骨质疏松症，另外3400万人因低骨量而增加了风险。此外，每年在65岁以上的患者中每年有超过340,000个骨质疏松性髋关节和700,000次脊柱骨折。尽管骨质疏松症的临床重要性，但仅诊断不足，并且只有12-14％的需要接受测试的人进行了12-14％的治疗。为了纠正这一点，O.N.诊断已开发出“辅助BCT”供临床使用。 BCT结合了CT扫描，骨生物力学和有限元分析的图像处理，以提供对患者CT扫描的BMD和全骨强度的估计。该SBIR项目的目的是使用多种典型的临床CT检查来开发能够提供这些BMD和骨骼强度度量，其中BCT分析是对CT检查的“附加性”分析，该检查被订购，该检查被订购，以使其对非骨质疏松症的指示进行，从而使患者在高风险中的识别和刺激性O HIP的识别，并使其对疾病的识别进行识别。骨质疏松症扫描并最大化现有成像检查的成本效益。我们估计，在美国，每年进行8-1亿个CT扫描包含髋关节或脊柱，并且在技术上适用于辅助BCT分析。我们的计划是为符合当前临床标准的CT患者提供辅助BCT，以进行DXA考试，但尚未接受DXA。在该项目的第一阶段，我们成功地开发了软件（Virtuost®），以使用先前获得的临床CT扫描来评估骨骼强度和BMD。该阶段II项目将重点介绍辅助BCT的全部临床实施所面临的剩余技术挑战。在AIM 1中，我们将通过自动图像处理步骤并将自动质量保证测试集成到分析工作流程中，从而提高吞吐量和可靠性，从而消除了与分析相关的程序间接费用，并将成本降低到不超过DXA考试的成本。利用现有的图像处理步骤，我们将添加椎体事实评估以增加BCT的价值。在AIM 2中，我们将使用特定于患者的X射线束能量估计值来优化无幻象校准技术，无论CT扫描仪或采集方案如何，该X射线束能将允许可重复的BCT结果。我们将将BCT分析扩展到以静脉对比度获得的腹部CT检查的50％，并解决了辅助BCT的监测指南。最后，在AIM 4中，我们将将所有这些进步整合到一项临床研究中，其中包括从大型且人口统计学上多样化的患者人群中获得的多种CT扫描仪和考试类型。为了关注临床翻译，我们还将进行成本效益分析，以确定要分析的最有效的检查类型，哪些患者将从健康经济学的角度从辅助BCT中受益。在这项SBIR研究结束时，我们将将辅助BCT分析的范围和临床实用性扩大到未进行DXA检查的风险患者，但进行了现有的CT检查，并确定这些患者中的哪个BCT将受益最大。