PURPOSE

To perform a pivotal study of the next-generation tomosynthesis system with volunteers recruited among women with suspicious breast finding(s), with the goal of assessing the effect of scanning method on characterization of findings as benign or malignant. The primary outcome variable for this 3D mammography imaging study is the recall rate for additional imaging, which should be minimized as much as possible without compromising the sensitivity for cancer detection. Secondary outcome variables that will be determined in reading sessions and calculations done retrospectively using the image data include: (1) lesion characterization metrics, which reflect radiologists' confidence in deciphering benign from malignant findings under different scanning methods; (2) 3D breast outline segmentations, which quantify cone-beam artifacts and volume overestimation artifacts under different scanning methods; and (3) quantitative texture and breast density measures, which act as surrogates of lesion detectability and tissue superposition effects.

You may be eligible for this study if you meet the following criteria:

• Conditions: Medical Research
• Age: - 99 Years
• Gender: All