CTRA Software Solution for Fracture Risk Assessment of Axial Skeleton

用于中轴骨架骨折风险评估的 CTRA 软件解决方案

• 批准号: 10013115
• 负责人: ARA NAZARIAN
• 金额: $ 149.09万
• 依托单位: BIOSENSICS, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-15 至 2022-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10013115
• 关键词: Address; Affect; Age; Algorithms; Architecture; Biological Assay; Body mass index; Bone Tissue; Bone neoplasms; Cancer Patient; Classification; Clinic; Clinical; Clinical Research; Code; Collaborations; Computer software; Data; Data Set; Databases; Development; Disease; Educational process of instructing; Elderly; Family; Female; Fracture; Funding; Gender; Geometry; Image; Imaging Phantoms; Impairment; International; Israel; Length; Lesion; Letters; Life Cycle Stages; Maintenance; Malignant Neoplasms; Malignant neoplasm of lung; Malignant neoplasm of prostate; Mechanics; Medical Device; Medical center; Metastatic Neoplasm to the Bone; Metastatic to; Methodology; Methods; Musculoskeletal; Neoplasm Metastasis; Neoplastic Processes; Neurologic; Neurologic Deficit; Pain; Paper; Pathological fracture; Patients; Phase; Prevention; Process; Property; Publishing; Quality of life; Race; Risk; Risk Assessment; Scanning; Sensitivity and Specificity; Series; Site; Skeleton; Small Business Innovation Research Grant; Societies; Software Design; Spinal; Standardization; Structure; Symptoms; Technology; Testing; Time; Trauma; Vertebral column; Woman; X-Ray Computed Tomography; aggressive therapy; anticancer research; automated segmentation; base; bone; bone imaging; clinical practice; commercialization; density; design; fracture risk; functional disability; high risk; image processing; imaging study; male; malignant breast neoplasm; men; middle age; neoplastic; older patient; pre-clinical; preclinical study; software development; spinal cord compression; spine bone structure; treatment response; tumor; validation studies; verification and validation; vertebra body

PROJECT SUMMARY/ABSTRACT Elderly patients with cancer have a higher risk of bony metastases than middle-aged patients (four times higher in men and three times higher in women). Approximately 50% of these cases of bony metastases involve the spine. Cancer patients are living longer as a result of new and aggressive treatments, but at sites of skeletal metastasis fractures occur in 17%-35% of affected bones after minimal trauma. Fractures due to metastatic disease in the spine vary from stable fractures with minimal pain and impairment to unstable fractures causing pain, major functional impairment, and neurologic deficits. Moreover, axial, skeletal metastases and the resultant fractures increase the risk for spinal instability, spinal cord compression, and neurological compromise. These complications have a devastating effect on quality of life, and, therefore prediction and prevention of fractures due to metastatic disease in the spine is critical. Clinicians currently make subjective assessments regarding a patient's fracture risk and response to treatment, which are now recognized to be inaccurate. To address this shortcoming, we have developed a methodology called Computed Tomography-based Rigidity Analysis (CTRA) for assessment of bone fracture risk. This method uses computed tomography (CT) images of the bone to calculate its structural rigidity, as a mechanical assay representing changes in bone tissue material and geometry induced by different factors such as age, trauma, or the neoplastic process. CTRA has been shown to provide estimates of bone load capacity and predict pathologic fractures in 20 ex-vivo, pre-clinical, and clinical studies. BioSensics is currently working on the development and commercialization of CTRA software for appendicular skeleton. This effort includes software design, as well as development of reimbursement strategies for CTRA, which is critical for large scale clinical usage of the technology and successful commercialization. In this Direct Phase II SBIR application, BioSensics, in collaboration with Beth Israel Deaconess Medical Center and Mayo Clinic, proposes to significantly expand the commercialization potential of CTRA by expanding its application to the axial skeleton. The aims of this project are to 1) Develop an age-, race- and gender-based normative structural rigidity database for the axial skeleton, 2) Develop fracture threshold values for CTRA analysis, 3) Develop auto-segmentation and material properties assignment algorithms, and 4) Develop and validate the CTRA software solution for axial skeleton. Software development will follow design controls in accordance with 21 CFR 820.30 and include life cycle processes required for the safe maintenance of the CTRA software based on International Standard IEC 62304 for medical device software.

项目总结/摘要 老年癌症患者骨转移的风险高于中年患者（4倍 男性高于女性三倍）。大约50%的骨转移病例涉及 脊柱由于新的积极治疗，癌症患者的寿命更长，但在骨骼部位， 在最小创伤后，17%-35%的受影响骨发生转移性骨折。转移性骨折 脊柱中的疾病从具有最小疼痛和损伤的稳定性骨折到引起 疼痛、主要功能障碍和神经功能缺损。此外，轴向骨转移和由此产生的 骨折增加了脊柱不稳定、脊髓压迫和神经损伤的风险。这些 并发症对生活质量具有破坏性影响，因此预测和预防骨折 因为脊柱转移性疾病是很关键的临床医生目前对患者进行主观评估 患者的骨折风险和对治疗的反应，现在被认为是不准确的。为了解决这个 缺点，我们已经开发了一种方法，称为基于计算机断层扫描的刚度分析（CTRA） 评估骨折风险。该方法使用骨骼的计算机断层扫描（CT）图像， 计算其结构刚度，作为代表骨组织材料和几何形状变化的力学测定 由不同因素如年龄、创伤或肿瘤过程引起。CTRA已被证明可以提供 在20项离体、临床前和临床研究中评估骨负荷能力并预测病理性骨折。 BioSensics目前正在开发和商业化CTRA软件， 无骨的骨架这项工作包括软件设计，以及偿还战略的发展 对于CTRA，这对于该技术的大规模临床使用和成功商业化至关重要。在 BioSensics与Beth Israel Deaconess Medical Center合作推出的Direct Phase II SBIR应用程序 和马约诊所，建议通过扩大其 应用于中轴骨骼。该项目的目标是：（1）制定一项基于年龄、种族和性别的 中轴骨的标准结构刚度数据库，2）开发CTRA的骨折阈值 分析，3）开发自动分割和材料属性分配算法，以及4）开发和 验证中轴骨骼的CTRA软件解决方案。软件开发将遵循 根据21 CFR 820.30，包括CTRA安全维护所需的生命周期过程 软件基于医疗器械软件的国际标准IEC 62304。