DEVELOPMENT OF PATIENT-DERIVED ANTHROPOMORPHIC BREAST PHANTOMS FOR AUTOMATED OBJECTIVE ASSESSMENT OF BREAST X-RAY IMAGING SYSTEMS

开发患者拟人化乳房模型，用于乳房 X 射线成像系统的自动客观评估

• 批准号: 10274065
• 负责人: PEYMON GHAZI
• 金额: $ 40万
• 依托单位: MALCOVA LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-16 至 2021-06-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10274065
• 关键词: 3-Dimensional; Breast; Clinical Trials; Collection; Data Set; Development; Development Plans; Device Safety; Diagnostic radiologic examination; Ensure; Evaluation; Goals; Health; Hospitals; Image; Imaging technology; Life; Manufacturer Name; Methodology; Methods; Patient Recruitments; Patients; Performance; Phase; Process; Research Personnel; Risk; Savings; Series; Shapes; Speed; Technology; Testing; breast imaging; density; design; digital; imaging system; improved; large datasets; malignant breast neoplasm; novel strategies; phantom model; product development; virtual model

As long as breast cancer remains a pervasive health concern, the need for ever-improving breast cancer imaging technology will exist. Design changes – to incorporate new hardware technologies or methods – may trigger the need for clinical trials to ensure device safety and assess performance. Conducting a clinical trial is not only expensive, but often takes years for patient recruitment and study. Utilizing physical phantoms, rather than patients, would be faster, far less expensive, reduce risk to patients and potentially increase the speed with which life-saving technological advances are made available to the public. Because currently available compressed and uncompressed breast phantoms are not real breast images, the users do not have this option. Utilizing our unique access to a large data set (over 1100) of three-dimensional real patient breast images and a novel approach to phantom development, we propose to fill this need. We propose a two-step process for the design, fabrication and evaluation of a collection of realistic anthropomorphic breast phantoms. From our large image data set we will generate the digital and physical phantoms for a series of phantoms spanning different breast shape, size, density and glandular distribution. Our product will be available to manufacturers, hospitals and researchers.

只要乳腺癌仍然是一个普遍的健康问题，就需要不断改进乳腺癌成像技术。设计变更-纳入新的硬件技术或方法-可能需要进行临床试验，以确保器械安全性和评估性能。进行临床试验不仅昂贵，而且往往需要数年的患者招募和研究。利用物理幻影，而不是病人，将更快，更便宜，减少病人的风险，并可能加快拯救生命的技术进步提供给公众。由于当前可用的压缩和未压缩乳房体模不是真实的乳房图像，因此用户没有此选项。利用我们独特的访问一个大的数据集（超过1100）的三维真实的患者乳房图像和一种新的方法来幻影发展，我们建议填补这一需求。我们提出了一个两步法的设计，制造和评估收集现实的拟人乳房模型。从我们的大型图像数据集，我们将产生一系列跨越不同乳房形状，大小，密度和腺体分布的体模的数字和物理体模。我们的产品将提供给制造商，医院和研究人员。