Neonatal Chest Phantom for Computed Radiography Testing

描述(由申请人提供)： ALARA的原则(尽可能低)是为了减少辐射照射引起的恶性风险，在实践中，这需要一个严格的放射学临床操作的质量控制过程。目前，质量控制所需的关键工具(射线照相测试体模)还不能用于计算机放射学和数字放射照相。该应用程序的长期目标是开发一种新的幻影和客观系统性能工具，用于数字放射成像系统。这些设备将用于满足计算机放射照相术和数字放射照相术的新需求。这些需求包括：(1)日常操作的质量控制程序；(2)评估产品和进行验收测试的质量保证方法；(3)优化系统运行参数的质量保证方法；(4)制造商评估新硬件和软件产品的开发工具。 由于新生儿胸部摄影是一项具有技术挑战性的过程，具有深刻的辐射剂量影响，因此在第一阶段成功地开发了原型新生儿胸部体模，并成为第二阶段体模开发的焦点。将开发新生儿胸部模型来模拟气胸和肺透明膜病的疾病状态。观察者诊断这两种疾病状态的能力将分别测试系统分辨率和噪声。还将开发一个自动化的客观系统性能工具，以测量可量化的参数，如分辨率(调制传递函数)、噪声(噪声功率谱)和探测器效率(探测量子效率)。第二阶段有两个具体目标：1)在正常和疾病状态下对新生儿胸部幻影进行临床验证；2)对客观系统性能工具进行临床验证。 成功的新生儿胸模设计将取决于图像的外观和直方图分析；解剖结构的衰减值；以及放射科医生在检测模体内疾病状态方面的诊断能力。成功的目标系统性能工具设计将通过与已建立的计算定量参数的方法的一致性来确定。推动商业应用的是该体模的临床意义，即确保最佳的设备性能和最大限度地减少X射线照射，从而降低伴随而来的新生儿恶性病变风险。

DESCRIPTION (provided by applicant): The principle of ALARA (as low as reasonably achievable) has been developed to reduce the risk of induced malignancy from radiation exposure, In practice this requires a rigorous quality control process for clinical operations in radiology. Currently, a critical tool (a radiographic test phantom) needed for quality control is not commercially available for computed radiology and digital radiography. The application's long-term goal is to develop a new class of phantoms and objective system performance tools for use in digital radiographic systems. These devices will be used to address emerging needs in computed radiography and digital radiography. These needs include (1) quality control procedures for daily operations, (2) quality assurance methods to evaluate products arid perform acceptance testing, (3) quality assurance methods for optimizing system operating parameters, and (4) development tools for manufacturers to assess new hardware and software products. Because neonatal chest radiography is a technically challenging procedure, with profound radiation dose implications, a prototype neonatal chest phantom was successfully developed in Phase I and is the focal point for Phase II phantom development. The neonatal chest phantom will be developed to simulate the disease states of pneumothorax and hyaline membrane disease. An observer's ability to diagnose these two disease states will test system resolution and noise, respectively. An automated objective system performance tool will also be developed to measure quantifiable parameters, such as resolution (modulation transfer function), noise (noise power spectrum), and detector efficiency (detective quantum efficiency). Phase II has two Specific Aims: 1) Clinical Validation of the Neonatal Chest Phantom in Normal and Disease States; 2) Clinical Validation of the Objective System Performance Tool. Successful neonatal chest phantom design will be determined by the appearance and histogram analysis of images; the attenuation values of anatomic structures; and the diagnostic performances of radiologists for detection of disease states within the phantom. Successful objective system performance tool design will be determined by agreement with established methods of calculating quantitative parameters. The commercial applications are driven by the phantom's clinical significance, which is to assure optimal equipment performance and minimize x-ray exposure, thereby reducing the concomitant risk of induced malignancy to neonates.