Ergonomic Comfort and Tolerance Trial Results for Digital Imaging Elasto Tomography (DIET) Breast Cancer Screening

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Approximately 1 in 10 cancers diagnosed worldwide are female breast cancer. Mammography is currently the only approved large-scale breast screening modality. However, mammography exposes females to varying levels of radiation, and discomfort due to breast compression, which reduces compliance. Digital Imaging Elasto Tomography (DIET) is an emerging low-cost, radiation-free, compression-free breast cancer screening system. DIET delivers a low-amplitude, low-frequency mechanical vibration to a breast at the nipple and measures surface motion response, which is used to infer underlying tissue properties and diagnose cancers based on the large (400∼1000%) contrast in stiffness between healthy and cancerous tissue. However, female tolerance of these vibration inputs is unknown.An ergonomic trial was conducted on 40 female subjects to quantify comfort and tolerance to the input mechanical vibration by finding the largest tolerable vibration felt on the breast surface. The trial tested a range of frequencies [20 Hz, 25 Hz, 30 Hz] and amplitudes [1.0 mm, 1.5 mm], whereas prior DIET trials used only a 0.5 mm input. Results show little discomfort below 25 Hz, with some discomfort increasing above this value due to lack of isolation of the actuator in the DIET prototype. Ten (N=10, 25%) trial participants had prior mammography experience, and rated the overall discomfort of DIET 1.85 out of 5 on average, compared to a mammography discomfort rating of 4.5 out of 5 on average (p < 0.05, Mann-Whitney). Participants with no mammogram experience found the procedure more comfortable (average discomfort rating 1.4 out of 5). The results show the DIET technology using input vibration amplitudes up to 3x larger than previously is a comfortable and tolerable screening technology, and was a preferred screening method in those women who had experienced mammography previously, thus showing promising potential uptake of such a technology to increase equity of breast screening and improve outcomes for women.