Painless Mammography

无痛乳房X光检查

• 批准号: 8350795
• 负责人: Margarita L Zuley
• 金额: $ 28.48万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-18 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8350795
• 关键词: Address; Affect; Anxiety; Area; Benefits and Risks; Breast; Breast Cancer Detection; Breast Cancer Early Detection; Clinical; Data Analyses; Data Collection; Data Set; Detection; Diagnostic; Digital Mammography; Dose; Effectiveness; Ensure; Evaluation; Film; Future; Generations; Goals; Image; Imaging technology; Institutional Review Boards; Mammary Gland Parenchyma; Mammography; Manufacturer Name; Morphologic artifacts; Motion; Pain; Painless; Palpable; Participant; Patients; Perception; Performance; Pilot Projects; Population; Procedures; Protocols documentation; Published Comment; Qualifying; Radiation; Reader; Reporting; Research Design; Schedule; Screening procedure; Series; Side; System; Technology; Testing; Thick; Three-Dimensional Image; Tissues; Woman; Women' s Group; Work; analog; base; calcification; clinical care; clinical practice; cost; design; detector; digital; experience; follow-up; innovation; new technology; radiologist; research study; tool; tumor; working group; young woman

DESCRIPTION (provided by applicant): Breast compression and associated discomfort is a major problem identified by women undergoing mammography in general and, in particular, in the screening population of younger women with denser breast tissue on average. While recognized as such, little has been done to date to alleviate and / or eliminate this mammography problem despite major advances in the technologies used for this purpose in clinical practice. The perceived need for maximum compression to ensure the ability of the radiologist to identify suspected abnormalities under current practices has been a major deterrent to change in this area, and indeed, in practice, technologists frequently exceed the recommended breast compression in the hope of providing the "best" image quality possible. As it turns out, it may take a relatively small reduction in breast compression to practically eliminate, or at least significantly and notably reduce, this problem. The primary goal of screening mammography, to visualize adequately micro-calcification and mass like abnormalities, can be addressed with a new technology, namely tomosynthesis, as tissue overlap is best identified and characterized on the 3D images and micro-calcification cluster detection is best identified and characterized on the 2D images. Hence, we propose to design, assemble, and test an innovative, practical approach to screening mammography that would reduce needed breast compression. Based on results from a study on breast thickness and pain level as a function of compression force, and, in cooperation with the manufacturer of the tomosynthesis system, we will design, assemble, and test new compression paddles that will enable adequate support of the breast at lower compression levels for all customary views. We will then perform a detailed preliminary assessment of radiologists' acceptance levels of the images produced with a lower compression level and perform a pilot observer performance study with a set of difficult cases when using images acquired with a conventional and a lower compression level. Should this approach prove to be successful, if needed and warranted, a larger pivotal study will be designed and proposed at the completion of this project. If such a study is ultimately deemed warranted and necessary, whether we are the ones to perform it or other groups, the work proposed here will be invaluable in terms of study design, assessment protocol, and, most important, estimation of effect sizes for power analyses to determine study size. This revised application addresses all comments made during a prior review. PUBLIC HEALTH RELEVANCE: We propose to investigate the feasibility / possibility of implementing "painless mammography" in clinical practice using a unique combination of new compression paddles and a tomosynthesis imaging based approach to screening mammography.

描述（由申请人提供）：乳房压缩和相关的不适是一般乳房X线摄影，尤其是在平均患有较密集的乳房组织较重的年轻妇女的筛查中，乳房X线摄影的妇女发现了一个主要问题。尽管因此被公认为，但迄今为止，尽管在临床实践中用于此目的的技术取得了重大进展，但几乎没有采取任何措施来减轻和 /或消除这种乳房X线摄影问题。人们认为，最大程度地压缩的需求确保放射科医生在当前实践下识别可疑异常的能力是对这一领域变化的主要威慑力，而且实际上，实际上，技术人员经常超过推荐的乳房压缩，以期提供可能的“最佳”图像质量。事实证明，乳房压缩的减少可能相对较小，以消除这个问题，或者至少显着减少了这个问题。筛查乳房X线摄影的主要目标，可以看到充分的微观造影和质量（如异常），可以通过新技术（即质膜合成）来解决，因为最好在3D图像和微观估计集群的检测中最好地识别组织重叠，并在2D图像上识别并表征2D图像。因此，我们建议设计，组装和测试一种创新的，实用的方法来筛查乳房X线摄影，以减少所需的乳房压缩。基于对胸部厚度和疼痛水平作为压缩力的函数的研究的结果，以及与Tomosynthessis System的制造商合作，我们将设计，组装和测试新的压缩桨，以较低的压缩水平在较低的压缩水平上获得足够的支持。然后，我们将对以较低的压缩水平产生的图像的接受水平进行详细的初步评估，并在使用具有常规压缩水平和较低压缩水平的图像时，使用一组困难案例进行试验观察者绩效研究。如果这种方法在需要并有必要的情况下成功地证明是成功的，则将在完成该项目完成时进行更大的关键研究。如果最终认为这项研究有必要并有必要，无论我们是执行它还是其他群体，此处提出的工作将在研究设计，评估方案以及最重要的效果大小的估算中是无价的，以确定研究规模。此修订的申请介绍了先前审查期间所作的所有评论。 公共卫生相关性：我们建议研究在临床实践中实施“无痛乳房摄影”的可行性 /可能性，采用新的压缩桨和基于质膜成像的筛查乳房X线摄影的独特组合。