Pre-Operative QCT Planning Protocol for Treating the Structural Deficiency of Spi

治疗 SPI 结构缺陷的术前 QCT 规划方案

• 批准号: 7475488
• 负责人: RON N ALKALAY
• 金额: $ 35.86万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-07-03 至 2012-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7475488
• 关键词: Accounting; Adult; Affect; Algorithms; Behavior; Biocompatible Materials; Biopolymers; Cadaver; Cancer Patient; Caring; Carrying Capacities; Categories; Chest; Classification; Clinical; Compatible; Complex; Computer Simulation; Condition; Containment; Cytotoxic agent; Daily; Data; Decompression Sickness; Defect; Dependency; Development; Elderly; Engineering; Exhibits; Failure; Finite Element Analysis; Fracture; Goals; Grant; Guidelines; High Chair; Homeostasis; Hormones; Human; Image; In Vitro; Incidence; Injectable; Intractable Pain; Invasive; Laboratories; Life; Life Expectancy; Ligaments; Linear Regressions; Location; Lytic; Lytic Metastatic Lesion; Malignant Neoplasms; Materials Testing; Measures; Mechanics; Metastatic Neoplasm to the Bone; Methods; Modeling; Monitor; Morbidity - disease rate; Muscle Rigidity; Nature; Neoplasm Metastasis; Neurologic; Operative Surgical Procedures; Osteolysis; Osteolytic; Outcome; Pathologic; Pathological fracture; Pathology; Patient Monitoring; Patients; Pattern; Performance; Physiological; Polymers; Polymethyl Methacrylate; Polyurethanes; Predisposition; Prevention; Probability; Procedures; Process; Property; Prophylactic treatment; Protocols documentation; Radiation; Radiation therapy; Range; Research; Resources; Risk; Role; Sensitivity and Specificity; Series; Simulate; Site; Skeletal system; Slice; Spinal; Spinal Fractures; Staging; Standards of Weights and Measures; Structure; System; Techniques; Testing; Time; Torsion; Tumor Pathology; Vertebral Bone; Vertebral column; Weight-Bearing state; Work; X-Ray Computed Tomography; base; bisphosphonate; bone; caN protocol; clinically relevant; cone-beam computed tomography; design; improved; in vivo; indexing; instrument; kinematics; loss of function; malignant breast neoplasm; novel; prevent; prophylactic; reconstitution; reconstruction; response; restoration; soft tissue; spine bone structure; tool; tumor

DESCRIPTION (provided by applicant): The spine is the skeletal site most often affected by metastatic breast cancer, and 17-50% of patients with spinal metastasis sustain a vertebral fracture. Systemic treatments with cytotoxic agents, hormone manipulation, bisphosphonates and/or local treatment with radiation and/or surgical stabilization, constitute the range of therapies available to breast cancer patients with skeletal metastasis. However, there are no objective methods for selecting which treatment will best reduce the patient's risk for sustaining a pathologic fracture and for monitoring the patient's response to therapy. Therefore, establishing objective criteria to evaluate the load carrying capacity of the involved vertebrae can be used both to monitor changes in bone structure that reflect the interaction of the tumor with the host bone, and to guide treatment for fracture prevention. Objective measures of fracture risk will both enhance patient management and resource utilization. Our overall hypothesis is that the loss of structural integrity of the spine due to tumor induced osteolysis, assessed using CT based structural analysis protocol, can be restored using structural polymers deployed in a minimally invasive manner. In Aim 1, in a series of in vitro tests, the ability of a QCT based structural analysis protocol to classify the fracture risk of thoracolumbar human spines with simulated critical osteolytic defects will be quantified under physiological loading conditions. Predicated fracture load, computed for the vertebrae, will be compared to the failure load measured by mechanical testing. The role of spinal ligaments in effecting the predicted failure load will be investigated. In Aim 2, a novel image-based algorithm will be developed and integrated within the CT structural analysis protocol, to provide pre-operative planning for prophylactic augmentation of the affected vertebra. Specific anatomically and materially detailed computational models will be used to optimize the design rules incorporated within the image based module to achieve restoration of the structural integrity of the affected vertebra. Using a series of in vitro studies, we will characterize the dependencies of the mechanical properties of treated vertebrae on the material properties of the injectable biopolymer and the geometrical properties of the lytic defect. We will compare this performance to the use of Polymethylmetacrylate cement. In Aim 3, the efficacy of the developed CT based pre-operative analysis, prediction and augmentation system, in restoring the structural integrity of thoracolumbar spines with simulated lytic defects, will be quantified. In summary, Drawing on principles of structural engineering, a novel CT based pre-operative analysis, prediction and augmentation system, will be developed to allow pre-operative planning for prophylactic augmentation of the human thoracolumbar spines with critical lytic defects.

描述（申请人提供）：脊柱是最常受转移性乳腺癌影响的骨骼部位，17-50%的脊柱转移患者会出现椎骨骨折。使用细胞毒剂、激素控制、双磷酸盐的全身治疗和/或使用放射和/或手术稳定的局部治疗构成了可用于骨转移的乳腺癌患者的治疗范围。然而，没有客观的方法来选择哪种治疗最能降低患者发生病理性骨折的风险并监测患者对治疗的反应。因此，建立客观标准来评估相关椎骨的承载能力既可以用来监测反映肿瘤与宿主骨相互作用的骨结构变化，也可以用来指导预防骨折的治疗。骨折风险的客观测量将加强患者管理和资源利用。我们的总体假设是，通过基于 CT 的结构分析方案评估，由于肿瘤引起的骨溶解而导致脊柱结构完整性的丧失，可以使用以微创方式部署的结构聚合物来恢复。在目标 1 中，在一系列体外测试中，将在生理负荷条件下量化基于 QCT 的结构分析协议对具有模拟关键溶骨缺陷的人体胸腰椎骨折风险进行分类的能力。针对椎骨计算的预测断裂载荷将与机械测试测量的失效载荷进行比较。将研究脊柱韧带在影响预测失效载荷中的作用。在目标 2 中，将开发一种新颖的基于图像的算法并将其集成到 CT 结构分析协议中，为受影响椎骨的预防性增强提供术前规划。具体的解剖学和材料细节计算模型将用于优化基于图像的模块中包含的设计规则，以实现受影响椎骨结构完整性的恢复。通过一系列体外研究，我们将描述治疗椎骨的机械性能对可注射生物聚合物的材料性能和溶解缺陷的几何性能的依赖性。我们将这种性能与聚甲基丙烯酸甲酯水泥的使用进行比较。在目标 3 中，将量化所开发的基于 CT 的术前分析、预测和增强系统在恢复具有模拟溶解缺陷的胸腰椎结构完整性方面的功效。总之，借鉴结构工程原理，将开发一种基于 CT 的新型术前分析、预测和增强系统，以便为具有严重溶解缺陷的人类胸腰椎的预防性增强提供术前规划。