CTRA Software Solution for Fracture Risk Assessment of Axial Skeleton

项目摘要/摘要 老年癌症患者骨转移的风险比中年患者高(4倍 男性更高，女性更高三倍)。在这些骨转移病例中，大约50%涉及 脊椎。由于新的积极治疗，癌症患者的寿命延长了，但在骨骼部位 在受影响的骨骼中，17%-35%的转移性骨折发生在微创后。转移性骨折 脊柱疾病从疼痛和损伤最小的稳定型骨折到导致 疼痛、主要功能障碍和神经缺陷。此外，轴性、骨骼转移和由此产生的 骨折会增加脊柱不稳、脊髓受压和神经损害的风险。这些 并发症对生活质量有破坏性的影响，因此预测和预防骨折 由于脊椎转移疾病是危急的。临床医生目前对一种 患者的骨折风险和对治疗的反应，现在被认为是不准确的。要解决这个问题 缺点是，我们开发了一种称为基于计算机断层扫描的刚性分析(CTRA)的方法 用于评估骨折风险。这种方法使用骨骼的计算机断层扫描(CT)图像来 计算其结构刚性，作为表示骨组织材料和几何形状变化的力学分析 由不同的因素引起的，如年龄、创伤或肿瘤过程。CTRA已被证明提供了 在20项体外、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目前正致力于CTRA软件的开发和商业化 附肢骨骼。这项工作包括软件设计以及报销策略的开发 对于CTRA，这对该技术的大规模临床应用和成功商业化至关重要。在……里面 该直接第二阶段SBIR应用程序BioSensics与贝丝以色列女执事医疗中心合作 和Mayo Clinic，建议通过扩展其 应用于轴向骨架。这个项目的目标是：1)制定一个基于年龄、种族和性别的 规范的轴向骨架结构刚度数据库；2)建立CTRA的断裂门槛值 分析，3)开发自动分割和材料属性分配算法，以及4)开发和 验证用于轴向骨骼的CTRA软件解决方案。软件开发将遵循以下设计控制 并包括安全维护CTRA所需的生命周期流程 基于国际标准IEC 62304的医疗器械软件。

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.