Painless Mammography

描述（由申请人提供）：乳房压迫和相关不适是接受乳房x光检查的女性普遍存在的主要问题，特别是在乳房组织平均较致密的年轻女性筛查人群中。虽然认识到这一点，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缓解和/或消除这种乳房x光检查问题。在目前的实践中，为了确保放射科医生能够识别可疑的异常，需要最大限度的压缩，这是阻碍这一领域变革的主要因素，事实上，在实践中，技术人员经常超过推荐的乳房压缩，希望提供“最佳”图像质量。事实证明，只需要稍微减少乳房压迫就可以消除，或者至少显著减少这个问题。乳房x光筛查的主要目标是充分显示微钙化和肿块样异常，这可以通过一种新技术来解决，即断层合成，因为在3D图像上可以最好地识别和表征组织重叠，而在2D图像上可以最好地识别和表征微钙化簇检测。因此，我们建议设计、组装和测试一种创新的、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程度作为压缩力的函数的研究结果，我们将与tomosynthesis系统的制造商合作，设计、组装和测试新的压缩桨，以便在所有常规视图的较低压缩水平下能够充分支持乳房。然后，我们将对放射科医生对较低压缩水平产生的图像的接受程度进行详细的初步评估，并在使用常规和较低压缩水平获得的图像时，对一组困难病例进行试点观察员性能研究。如果这种方法被证明是成功的，如果需要和保证，将在本项目完成时设计和提出更大的关键研究。如果这样的研究最终被认为是合理的和必要的，无论我们是执行它的人还是其他小组，这里提出的工作将在研究设计，评估方案方面是无价的，最重要的是，估计功效分析的效应大小，以确定研究规模。此修订后的申请解决了在先前审查期间提出的所有意见。

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.