Painless Mammography

无痛乳房X光检查

• 批准号: 8547033
• 负责人: Margarita L Zuley
• 金额: $ 29.79万
• 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 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8547033
• 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; 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; screening; 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.

描述（由申请人提供）：乳房受压和相关不适是接受乳房 X 光检查的女性普遍发现的一个主要问题，特别是在平均乳腺组织较致密的年轻女性筛查人群中。尽管人们认识到这一点，但迄今为止，尽管临床实践中用于此目的的技术取得了重大进展，但在减轻和/或消除这种乳房X线照相术问题方面却几乎没有采取任何措施。人们认为需要最大程度的压缩以确保放射科医生在当前实践中识别可疑异常的能力，这一直是该领域变革的主要障碍，事实上，在实践中，技术人员经常超过建议的乳房压缩，希望提供可能的“最佳”图像质量。事实证明，可能需要相对较小的乳房压缩减少才能实际上消除或至少显着且显着地减少这个问题。筛查乳房 X 光检查的主要目标是充分可视化微钙化和肿块样异常，可以通过新技术（即断层合成）来实现，因为在 3D 图像上可以最好地识别和表征组织重叠，并且可以最好地识别微钙化簇检测并在二维图像上进行表征。因此，我们建议设计、组装和测试一种创新、实用的乳房 X 线摄影筛查方法，以减少所需的乳房压迫。根据对乳房厚度和疼痛水平与压缩力的关系的研究结果，并与断层合成系统制造商合作，我们将设计、组装和测试新的压缩桨，以充分支撑乳房所有习惯视图都处于较低的压缩级别。然后，我们将对放射科医生对较低压缩级别生成的图像的接受程度进行详细的初步评估，并在使用以传统和较低压缩级别获取的图像时对一组困难情况进行试点观察者性能研究。如果这种方法被证明是成功的，如果需要和有保证的话，将在该项目完成时设计和提出更大规模的关键研究。如果这样的研究最终被认为是合理和必要的，无论是我们还是其他团体进行这项研究，这里提出的工作在研究设计、评估方案以及最重要的是功效效应大小的估计方面都将是无价的分析以确定研究规模。此修订后的申请解决了先前审查期间提出的所有意见。