Fracture Risk Assessment Software for Skeletal Metastasis

骨骼转移骨折风险评估软件

• 批准号: 9047548
• 负责人: Joseph T Gwin
• 金额: $ 75万
• 依托单位: BIOSENSICS, LLC
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-01 至 2017-09-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9047548
• 关键词: Accounting; Affect; Age; Area; Area Under Curve; Benign; Biological Assay; Body mass index; Bone Tissue; Boston; Calibration; Cancer Patient; Case-Control Studies; Characteristics; Child; Classification; Clinic; Clinical; Code; Computer software; Confidence Intervals; Contralateral; Data; Databases; Development; Discrimination; Disseminated Malignant Neoplasm; Failure; Femur; Fracture; Funding; Gender; General Population; Geometry; Height; Image; Insurance; Learning; Length; Lesion; Letters; Libraries; Licensing; Life; Limb structure; Location; Malignant Neoplasms; Mechanics; Medical; Medical Device; Memorial Sloan-Kettering Cancer Center; Metabolic; Metastatic Neoplasm to the Bone; Methodology; Methods; Musculoskeletal; Musculoskeletal Diseases; Neoplasm Metastasis; Neoplastic Processes; Paper; Pathological fracture; Patients; Pediatric Hospitals; Phase; Physicians; Procedures; Process; Property; Publishing; Quality of life; Radiation; Receiver Operating Characteristics; Registries; Reporting; Risk; Risk Assessment; Safety; Sensitivity and Specificity; Site; Skeleton; Small Business Innovation Research Grant; Societies; Software Design; Specificity; Structure; Subgroup; Symptoms; Trauma; Universities; Upper Extremity; Validation; Weight; Work; X-Ray Computed Tomography; anticancer research; base; bone; bone age; cancer type; commercialization; humerus; in vivo; indexing; neoplastic; pre-clinical; predictive modeling; prevent; public health relevance; skeletal neoplasm; treatment response; tumor

 DESCRIPTION (provided by applicant): The skeleton is the third most common site of metastatic cancer, and nearly half of all cancers metastasize to bone. As a result of new and aggressive treatments, cancer patients are living longer, but at sites of skeletal metastasis, fractures occur in up to 35% of affected bones after minimal trauma, significantly impacting patient function and quality of life. Preventing fractures due to skeletal metastases depends on objective criteria that reflect the interaction of the tumor with the host bone. While much has been learned about the mechanisms of skeletal metastasis, clinicians continue to make subjective assessments regarding a patient's fracture risk and response to treatment based on plain radiographs and clinical symptoms now recognized to be inaccurate. Metastatic cancer alters both the material and geometric properties of the bone; failure to account for changes in both of these parameters limits the accuracy of current fracture prediction methodologies/scores. As it is the weakest segment through the bone that dictates the load capacity of the entire structure, we have developed a software package, called Computed Tomography-based Rigidity Analysis (CTRA), to calculate the minimal rigidity of a bone containing a neoplastic lesion. This method uses computed tomography (CT) images of the affected bone to calculate its structural rigidity, as a mechanical assay representing changes in bone tissue material and geometry induced by the neoplastic process. The accuracy of this approach for estimating load capacity and predicating pathologic fractures has been validated in ex-vivo, pre- clinical, and in-vivo studies, including a recent paper published in Clinical Cancer Research. This study was funded by the Musculoskeletal Tumor Society, which supports the commercialization of the software (please see letter of support).The software is currently being using at Boston Children's Hospital to assess fracture risk in children with benign lesions. Over the past 2 years, over 50 cases have been analyzed using CTRA at CHB, and the analysis results have been submitted to and reimbursed by insurance companies. Moreover, the commercialized product can be used in other areas such as fragility fracture prediction, metabolic and developmental musculoskeletal diseases and fracture non-unions. For this Direct Phase II SBIR submission, we propose to commercialize the software platform to make CTRA analysis available to clinicians. This work involves the establishment of a normative database of appendicular skeleton as a reference to interpret patient data; and to further refine our existing fracture threshold values for axial, bending and torsional rigidity indices to provide additional sensitivity for our analysis method. Therefore, the aims of the study are to: Develop a normative structural rigidity database for the appendicular skeleton as a reference for interpreting patient specific data; Optimize the threshold for reduction in rigidity indices that will determine fracturs from non-fractures with maximal sensitivity and specificity; and Develop the CTRA software to streamline and optimize the CTRA analysis procedure.

 描述（由适用提供）：骨骼是转移性癌症的第三大常见部位，几乎一半的癌症转移到骨头。由于新的和侵略性的治疗，癌症患者的寿命更长，但是在骨骼转移的部位，最小创伤后高达35％的骨折发生骨折，严重影响患者的功能和生活质量。防止骨骼转移引起的断裂取决于反映肿瘤与宿主骨骼相互作用的客观标准。尽管已经了解了骨骼转移的机制，但临床医生继续对患者的骨折风险和基于普通的X光片和治疗的反应进行评估，现在被认为是不准确的临床症状。转移性癌症会改变骨骼的材料和几何特性。未能说明这两个参数的变化都会限制当前断裂预测方法/得分的准确性。由于通过骨头的弱段决定了整个结构的负载能力，因此我们开发了一个称为基于计算机断层扫描的刚性分析（CTRA）的软件包，以计算含有肿瘤病变的骨头的最小刚性。该方法使用受影响骨骼的计算机断层扫描（CT）图像来计算其结构刚度，作为代表骨组织材料和肿瘤过程诱导的几何形状变化的机械测定。这种方法估计负荷能力和预测病理骨折的准确性已在前体内，临床前和体内研究中得到验证，其中包括最近发表在临床癌症研究中的一篇论文。这项研究由肌肉骨骼肿瘤协会资助，该协会支持该软件的商业化（请参阅支持信）。该软件目前正在波士顿儿童医院使用，以评估良性病变儿童的骨折风险。在过去的两年中，使用CTRA在CHB上分析了50多个案例，分析结果已由保险公司提交并报销。此外，商业化产品可用于其他领域，例如脆弱性断裂预测，代谢和发育性肌肉骨骼疾病和骨折非工会。对于此直接II期SBIR提交，我们建议将软件平台商业化，以使CTRA分析可用于临床医生。这项工作涉及建立正常的阑尾骨骼数据库作为解释患者数据的参考；并进一步完善我们现有的轴向，弯曲和扭转刚度指数的断裂阈值值，以为我们的分析方法提供额外的灵敏度。因此，该研究的目的是：为阑尾骨骼开发正常的结构刚度数据库，作为解释患者特定数据的参考；优化降低刚性指数的阈值，这些刚性指数将确定具有最大灵敏度和特异性的非裂缝的分裂；并开发CTRA软件以简化和优化CTRA分析过程。