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.
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.
|Starkweather, Angela R; Sherwood, Paula; Lyon, Debra E et al. (2014) Depressive symptoms and cytokine levels in Serum and Tumor Tissue in patients with an Astrocytoma: a pilot study. BMC Res Notes 7:423|