SBIR Phase I: Development of a novel, high-sensitivity diagnostic for bone disease, enabling early-stage diagnosis and precise monitoring of therapy effects.

SBIR 第一阶段：开发一种新型、高灵敏度的骨疾病诊断方法，实现早期诊断和精确监测治疗效果。

• 批准号: 1548339
• 负责人: Kristin James
• 金额: $ 15万
• 依托单位: bioProtonics, LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-01-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1548339&HistoricalAwards=false
• 关键词: SBIR; Phase; Development; novel; sensitivity

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase l Project, if successful, is the introduction of a new diagnostic paradigm that can significantly increase the ability of clinicians to diagnose early stage bone pathology resulting from age, osteoarthritis, and cancer therapy. While the current standard of bone care relies on a measurement of overall bone density, this new technology assesses the microstructure within bone, a measure that correlates much more strongly with fracture risk and disease stage. Along with providing an accurate measure of fracture risk, this technology will enable sensitive measure to: 1) target patients for inclusion in therapy trials, and 2) enable monitoring of the efficacy of these therapies towards amelioration of an excruciatingly painful pathology with a dire prognosis (half of people suffering hip fracture never regain their ability to live independently, and are at significantly increased risk of further fractures). As such, the commercial market, driven by pharmaceutical companies and diagnostic equipment manufacturers, is large. While the focus of this SBIR project is to develop a diagnostic for bone disease, the development will inform future application of the diagnostic technology to a large range of diseases for which no non-invasive, early-stage diagnostic currently exists. The proposed project is designed to validate the ability of this new magnetic-resonance based diagnostic to provide a sensitive measure of trabecular bone morphometry parameters, in a clinically relevant environment. Direct measurement of the changes in trabecular bone microarchitecture that are the harbinger of bone disease is outside the capability of current magnetic resonance imaging, resolution being limited by patient motion over the long times needed to generate an image. The new diagnostic will have the ability to acquire the requisite data with immunity to patient motion, increasing resolution significantly, and enabling sensitive measurement of trabecular bone morphometry parameters. Validation of this ability will be through application to a set of 3D-printed phantoms of increasing textural complexity and cadaver vertebrae, with use of a purpose-built apparatus capable of inducing clinically relevant motion profiles during data acquisition. The major focus of this effort is optimization of the acquisition and analysis software so as to achieve the high resolution needed to measure trabecular element width in osteoporotic bone.

小企业创新研究L项目如果成功，其更广泛的影响/商业潜力将是引入了一种新的诊断范式，可以显著提高临床医生诊断因年龄、骨关节炎和癌症治疗而导致的早期骨病理的能力。虽然目前的骨骼护理标准依赖于总体骨密度的测量，但这项新技术评估了骨骼内的微结构，这一测量与骨折风险和疾病阶段的相关性更强。除了提供准确的骨折风险测量外，这项技术还将使敏感措施能够：1)将患者纳入治疗试验，以及2)监测这些治疗方法的疗效，以改善具有可怕预后的极度痛苦的病理(髋部骨折患者中有一半永远无法恢复独立生活能力，进一步骨折的风险显著增加)。因此，由制药公司和诊断设备制造商推动的商业市场是巨大的。虽然这个SBIR项目的重点是开发一种骨骼疾病的诊断方法，但这一发展将使该诊断技术未来应用于目前尚不存在非侵入性早期诊断的大范围疾病。这项拟议的项目旨在验证这种基于磁共振的新诊断方法在临床相关环境中提供骨小梁形态测量参数的灵敏测量的能力。直接测量骨小梁微结构的变化是骨骼疾病的先兆，这超出了当前磁共振成像的能力，分辨率受到患者在生成图像所需的较长时间内的运动的限制。新的诊断系统将能够获得不受患者运动影响的必要数据，显著提高分辨率，并能够对骨小梁形态参数进行灵敏测量。这种能力的验证将通过应用于一组结构日益复杂的3D打印模型和身体脊椎，并使用一种专门建造的设备，能够在数据采集期间诱导临床相关的运动轮廓。这项工作的主要重点是优化采集和分析软件，以获得测量骨质疏松骨小梁元素宽度所需的高分辨率。