Fracture Risk Assessment Software for Skeletal Metastasis

项目总结/摘要 骨骼是转移性癌症的第三大常见部位，近一半的癌症转移到骨骼。 骨头由于新的和积极的治疗癌症患者的寿命更长，但在骨骼的网站， 在最小创伤后，17%-35%的受影响骨发生转移性骨折。这对 患者功能和生活质量。虽然已经了解了很多关于骨骼肌的机制， 尽管如此，临床医生仍然对患者的骨折风险进行主观评估。我们有 开发了一种称为基于计算机断层扫描的刚度分析（CTRA）的方法， 使用断层扫描（CT）图像来计算包含肿瘤病变的骨的最小刚度， 目的是估计负荷能力和预测病理性骨折。CTRA方法已被 在体外、临床前和体内研究中得到验证。 CTRA的alpha版本是出于研究目的而开发的。虽然它不打算或销售给 临床使用，它正在临床上使用在几个不同的医院在一个医生的判断。 使用CTRA的医生在CPT代码下由公共和私人付款人报销不一致 76499“未收载的诊断性放射学检查程序。”当没有其他特定的 程序代码存在。在初始部署期间的低容量情况下，这是可行的，但对于CTRA来说，要成为 需要标准治疗、FDA 510（k）许可和非通用I类CPT代码。 通过正在进行的直接第二阶段SBIR，我们正在开发商业质量的CTRA软件包 该系统将与医院图像存档和通信系统（PACS）集成，并完全自动化 CTRA过程。这项CRP赠款将帮助我们弥合产品开发和成功之间的差距。 医疗软件商业化 因此，前两个目标属于技术援助类别，而后两个目标则属于 后期研发类别如下：目标1：准备FDA 510（k）所需的所有文件 提交CTRA软件：目标2：准备向美国医学协会提交申请 (AMA)对于I类CPT代码：目标3：软件设计验证和确认活动：以及目标 4：消除对成像体模的需要。考虑到临床需要和已证实的准确性， 肌肉骨骼肿瘤协会（MSTS）支持CTRA的商业化，并已 已经承诺在申请CPT代码的过程中协助我们（参见MSTS支持信）。

PROJECT SUMMARY/ABSTRACT 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 17%-35% of affected bones after minimal trauma. This significantly impacts patient functioning and quality of life. While much has been learned about the mechanisms of skeletal metastasis, clinicians continue to make subjective assessments regarding a patient's fracture risk. We have developed a method, called Computed Tomography-based Rigidity Analysis (CTRA), to use computed tomography (CT) images to calculate the minimal rigidity of a bone containing a neoplastic lesion for the purposes of estimating load capacity and predicting pathologic fractures. The CTRA method has been validated in ex-vivo, pre-clinical, and in-vivo studies. An alpha version of CTRA was developed for research purposes. While it is not intended or marketed for clinical use, it is being used clinically in several different hospitals at the discretion of a medical doctor. Physicians using CTRA have been inconsistently reimbursed by public and private payers under CPT code 76499 “Unlisted Diagnostic Radiographic Procedure.” This generic code is used when no other specific procedure code exists. At low volumes during initial deployment this is feasible, but for CTRA to become a standard of care, FDA 510(k) clearance and a non-generic Category I CPT code are needed. Through an ongoing Direct Phase II SBIR we are developing a commercial quality CTRA software package that will integrate with hospital picture archiving and communication systems (PACS) and fully automate the CTRA process. This CRP grant will help us bridge the gap between product development and successful medical software commercialization. Therefore, the first two aims fall into the category of Technical Assistance, whereas the last two aims fall into the Late Stage R&D categories follows: Aim 1: prepare all required documentation for an FDA 510(k) submission for CTRA software: Aim 2: prepare an application to the American Medical Association (AMA) for a Category I CPT code: Aim 3: software design verification and validation activities: and Aim 4: eliminate the need for an imaging phantom. Given the clinical need and proven accuracy of the approach, the Musculoskeletal Tumor Society (MSTS) supports the commercialization of CTRA and has already committed to assisting us in the process of applying for a CPT code (see MSTS Letter of Support).