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线摄影的女性普遍存在的主要问题，尤其是在平均乳腺组织致密的年轻女性筛查人群中。尽管已经认识到这一点，但迄今为止几乎没有做什么来减轻和/或消除这种乳房X线摄影问题，尽管在临床实践中用于此目的的技术取得了重大进展。认为需要最大的压缩，以确保放射科医生的能力，以确定可疑的异常，在目前的做法已经成为一个主要的威慑力，在这方面的变化，实际上，在实践中，技术人员经常超过推荐的乳房压缩，希望提供“最好的”图像质量可能。事实证明，它可能需要一个相对较小的减少乳房压缩，以实际消除，或至少显着减少，这个问题。筛查乳腺X线摄影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（即断层合成）来解决，因为组织重叠在3D图像上得到最佳识别和表征，微钙化簇检测在2D图像上得到最佳识别和表征。因此，我们建议设计，组装和测试一种创新的，实用的方法来筛选乳腺X线摄影，将减少所需的乳房压缩。根据一项关于乳房厚度和疼痛水平作为压迫力函数的研究结果，并与断层合成系统的制造商合作，我们将设计、组装和测试新的压迫板，该压迫板将能够在所有常规视图的较低压迫水平下充分支撑乳房。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，并在使用传统和较低压缩水平采集的图像时，对一组困难病例进行试点观察员性能研究。如果该方法被证明是成功的，如果需要和保证，将在该项目完成时设计和提议一项更大的关键研究。如果这样的研究最终被认为是有必要的，无论是我们还是其他小组，这里提出的工作在研究设计，评估方案方面都是非常宝贵的，最重要的是，估计功效分析的效应量以确定研究规模。本修订版申请解决了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.