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使用人体乳房模型评估五个临床 DBT 系统的基于任务的性能。

Assessment of task-based performance from five clinical DBT systems using an anthropomorphic breast phantom.

机构信息

US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.

Michigan Medicine, University of Michigan, 1500 East Medical Center Drive, Ann Arbor, MI, 48109, USA.

出版信息

Med Phys. 2021 Mar;48(3):1026-1038. doi: 10.1002/mp.14568. Epub 2021 Jan 28.

Abstract

PURPOSE

Digital breast tomosynthesis (DBT) is a limited-angle tomographic breast imaging modality that can be used for breast cancer screening in conjunction with full-field digital mammography (FFDM) or synthetic mammography (SM). Currently, there are five commercial DBT systems that have been approved by the U.S. FDA for breast cancer screening, all varying greatly in design and imaging protocol. Because the systems are different in technical specifications, there is a need for a quantitative approach for assessing them. In this study, the DBT systems are assessed using a novel methodology with an inkjet-printed anthropomorphic phantom and four alternative forced choice (4AFC) study scheme.

METHOD

A breast phantom was fabricated using inkjet printing and parchment paper. The phantom contained 5-mm spiculated masses fabricated with potassium iodide (KI)-doped ink and microcalcifications (MCs) made with calcium hydroxyapatite. Images of the phantom were acquired on all five systems with DBT, FFDM, and SM modalities where available using beam settings under automatic exposure control. A 4AFC study was conducted to assess reader performance with each signal under each modality. Statistical analysis was performed on the data to determine proportion correct (PC), standard deviations, and levels of significance.

RESULTS

For masses, overall detection was highest with DBT. The difference in PC was statistically significant between DBT and SM for most systems. A relationship was observed between increasing PC and greater gantry span. For MCs, performance was highest with DBT and FFDM compared to SM. The difference between PC of DBT and PC of SM was statistically significant for all manufacturers.

CONCLUSIONS

This methodology represents a novel approach for evaluating systems. This study is the first of its kind to use an inkjet-printed anthropomorphic phantom with realistic signals to assess performance of clinical DBT imaging systems.

摘要

目的

数字乳腺断层合成摄影术(DBT)是一种有限角度的断层乳腺成像方式,可与全视野数字化乳腺摄影术(FFDM)或合成乳腺摄影术(SM)联合用于乳腺癌筛查。目前,有五种商业 DBT 系统已获得美国 FDA 批准用于乳腺癌筛查,这些系统在设计和成像方案上差异很大。由于系统在技术规格上存在差异,因此需要一种定量方法来评估它们。在这项研究中,使用一种新的方法学,结合喷墨打印的人体模型和四选一的强制选择(4AFC)研究方案,对 DBT 系统进行了评估。

方法

使用喷墨打印和羊皮纸制作了一个乳腺模型。该模型包含 5mm 有毛刺肿块,用碘化钾(KI)掺杂墨水制作,微钙化(MC)用羟磷灰石钙制作。在可用的情况下,使用自动曝光控制下的射线设置,在所有五个系统上采集了模型的 DBT、FFDM 和 SM 模式的图像。进行了 4AFC 研究,以评估在每种模式下每个信号的读者表现。对数据进行了统计分析,以确定正确比例(PC)、标准差和显著性水平。

结果

对于肿块,总体检测率以 DBT 最高。对于大多数系统,在 DBT 和 SM 之间,PC 的差异具有统计学意义。观察到随着机架跨度的增加,PC 也随之增加。对于 MCs,与 SM 相比,DBT 和 FFDM 的性能最高。在所有制造商中,DBT 的 PC 与 SM 的 PC 之间的差异具有统计学意义。

结论

该方法代表了一种评估系统的新方法。这项研究是首次使用喷墨打印的人体模型和现实信号来评估临床 DBT 成像系统性能的研究。

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