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6/8/2017 Disclosures Employee of Delphinus Medical Technologies A comparison of Volpara mammographic breast density with UST sound speed measurements Mark Sak 8th International Breast Density and Cancer Risk Assessment Workshop June 8,

  1. 6/8/2017 Disclosures • Employee of Delphinus Medical Technologies A comparison of Volpara mammographic breast density with UST sound speed measurements Mark Sak 8th International Breast Density and Cancer Risk Assessment Workshop June 8, 2017 Introduction SoftVue • Ultrasound tomography (UST) is an emerging non-ionizing breast imaging modality that can produce volumetric images of breast anatomy • Volumetric UST sound speed imaging has been shown to correlate strongly with mammographic percent density measurements made using CUMULUS • Volpara is a fully automated breast density assessment software that estimates the volume of fibroglandular tissue in the breast from digital mammograms • Direct comparisons between these two modalities have yet to be made 1

  2. 6/8/2017 UST Data Acquisition UST Sound Speed Imaging Ray-based – Uses time-of-flight measurements Waveform Image – Uses full waveform K v = 3 K v ∝ ρ ∝ ρ ρ UST Sound Speed Measurements Methods • 183 symptomatic women received both a UST scan and a Volpara breast density reading of their mammogram at the Karmanos Cancer Institute (KCI) in Detroit, MI • UST scans occurred between 2014 and 2016 while mammograms were analyzed with Volpara between 2015 and 2016 • 100 women had received both assessments within 100 days of each other • Various volumetric breast density measures were then recorded from each modality 2

  3. 6/8/2017 Volpara Measurements Average Results Average Value (Standard Density Measure Deviation) Days Between Mammogram and UST Scan 29 (30) Age (years) 50.8 (11) Weight (lbs) 184.8 (43.9) Height (inches) 64.8 (3.1) BMI (kg/m 2 ) 30.9 (6.6) UST Mean SS (m/s) 1443.1 (23.2) UST Total Volume (cm 3 ) 833 (495) UST Dense SS (m/s) 1467.8 (26) UST Dense Volume (cm 3 ) 219 (137) UST Fat SS (m/s) 1432.8 (18.5) UST Fat Volume (cm 3 ) 614 (396) UST Percent Density (%) 29 (12.4) Volpara Total Breast Volume (cm 3 ) 1130 (631) Volpara Dense Breast Volume (cm 3 ) 75 (40) Volpara Percent Density (%) 8.4 (5.4) Average Results Average Results Average Value (Standard Average Value (Standard Density Measure Density Measure Deviation) Deviation) Days Between Mammogram and UST Scan 29 (30) Days Between Mammogram and UST Scan 29 (30) Age (years) 50.8 (11) Age (years) 50.8 (11) Weight (lbs) 184.8 (43.9) Weight (lbs) 184.8 (43.9) Height (inches) 64.8 (3.1) Height (inches) 64.8 (3.1) BMI (kg/m 2 ) 30.9 (6.6) BMI (kg/m 2 ) 30.9 (6.6) UST Mean SS (m/s) 1443.1 (23.2) UST Mean SS (m/s) 1443.1 (23.2) UST Total Volume (cm 3 ) 833 (495) UST Total Volume (cm 3 ) 833 (495) UST Dense SS (m/s) 1467.8 (26) UST Dense SS (m/s) 1467.8 (26) UST Dense Volume (cm 3 ) 219 (137) UST Dense Volume (cm 3 ) 219 (137) UST Fat SS (m/s) 1432.8 (18.5) UST Fat SS (m/s) 1432.8 (18.5) UST Fat Volume (cm 3 ) 614 (396) UST Fat Volume (cm 3 ) 614 (396) UST Percent Density (%) 29 (12.4) UST Percent Density (%) 29 (12.4) Volpara Total Breast Volume (cm 3 ) Volpara Total Breast Volume (cm 3 ) 1130 (631) 1130 (631) Volpara Dense Breast Volume (cm 3 ) 75 (40) Volpara Dense Breast Volume (cm 3 ) 75 (40) Volpara Percent Density (%) 8.4 (5.4) Volpara Percent Density (%) 8.4 (5.4) 3

  4. 6/8/2017 Average Results Density Measures Spearman Correlations Average Value (Standard UST Mean Sound Speed (m/s) Volpara Percent Density (%) UST Percent Density (%) Density Measure Deviation) Age (years) -0.228 (0.022) -0.279 (0.005) -0.108 (0.287) Days Between Mammogram and UST Scan 29 (30) Weight (lbs) -0.567 (< 0.001) -0.621 (< 0.001) -0.405 (< 0.001) Age (years) 50.8 (11) Height (inches) -0.156 (0.120) -0.135 (0.181) 0.010 (0.920) Weight (lbs) 184.8 (43.9) BMI (kg/m 2 ) -0.568 (< 0.001) -0.647 (< 0.001) -0.461 (< 0.001) Height (inches) 64.8 (3.1) N/A 0.836 (< 0.001) 0.530 (< 0.001) UST Mean SS (m/s) BMI (kg/m 2 ) 30.9 (6.6) UST Total Volume (cm 3 ) -0.527 (< 0.001) -0.546 (< 0.001) -0.410 (< 0.001) UST Mean SS (m/s) 1443.1 (23.2) UST Dense SS (m/s) 0.897 (< 0.001) 0.803 (< 0.001) 0.273 (0.006) UST Total Volume (cm 3 ) 833 (495) UST Dense Volume (cm 3 ) -0.232 (0.020) -0.181 (0.071) 0.203 (0.043) UST Dense SS (m/s) 1467.8 (26) UST Fat SS (m/s) 0.950 (< 0.001) 0.711 (< 0.001) 0.380 (< 0.001) UST Dense Volume (cm 3 ) 219 (137) UST Fat Volume (cm 3 ) -0.584 (< 0.001) -0.615 (< 0.001) -0.561 (< 0.001) UST Fat SS (m/s) 1432.8 (18.5) UST Percent Density (%) 0.530 (< 0.001) 0.608 (< 0.001) N/A UST Fat Volume (cm 3 ) 614 (396) Volpara Total Breast Volume (cm 3 ) -0.550 (< 0.001) -0.641 (< 0.001) -0.516 (< 0.001) UST Percent Density (%) 29 (12.4) Volpara Dense Breast Volume (cm 3 ) 0.275 (0.006) 0.386 (< 0.001) 0.045 (0.658) Volpara Total Breast Volume (cm 3 ) 1130 (631) Volpara Percent Density (%) 0.836 (< 0.001) N/A 0.608 (< 0.001) Volpara Dense Breast Volume (cm 3 ) 75 (40) Volpara Percent Density (%) 8.4 (5.4) Density Measures Spearman Correlations Density Measures Spearman Correlations UST Mean Sound Speed (m/s) Volpara Percent Density (%) UST Percent Density (%) Age (years) -0.228 (0.022) -0.279 (0.005) -0.108 (0.287) Weight (lbs) -0.567 (< 0.001) -0.621 (< 0.001) -0.405 (< 0.001) Height (inches) -0.156 (0.120) -0.135 (0.181) 0.010 (0.920) BMI (kg/m 2 ) -0.568 (< 0.001) -0.647 (< 0.001) -0.461 (< 0.001) UST Mean SS (m/s) N/A 0.836 (< 0.001) 0.530 (< 0.001) UST Total Volume (cm 3 ) -0.527 (< 0.001) -0.546 (< 0.001) -0.410 (< 0.001) 0.897 (< 0.001) 0.803 (< 0.001) 0.273 (0.006) UST Dense SS (m/s) -0.232 (0.020) -0.181 (0.071) 0.203 (0.043) UST Dense Volume (cm 3 ) UST Fat SS (m/s) 0.950 (< 0.001) 0.711 (< 0.001) 0.380 (< 0.001) UST Fat Volume (cm 3 ) -0.584 (< 0.001) -0.615 (< 0.001) -0.561 (< 0.001) UST Percent Density (%) 0.530 (< 0.001) 0.608 (< 0.001) N/A Volpara Total Breast Volume (cm 3 ) -0.550 (< 0.001) -0.641 (< 0.001) -0.516 (< 0.001) r s = 0.608 (< 0.001) r s = 0.530 (< 0.001) r s = 0.836 (< 0.001) Volpara Dense Breast Volume (cm 3 ) 0.275 (0.006) 0.386 (< 0.001) 0.045 (0.658) Volpara Percent Density (%) 0.836 (< 0.001) N/A 0.608 (< 0.001) 4

  5. 6/8/2017 Volumetric Spearman Correlations Density Groupings Radiologist BIRADS Volpara Grade a b c d a b c d Count 8 43 38 11 28 26 33 13 Age (years) 50.8 54.9 48.4 43.8 50.9 56.1 50.4 41.4 Weight (lbs) 220.9 201.2 172.0 138.7 217.2 194.2 171.8 129.2 Height (inches) 65.6 64.9 65.0 62.8 65.2 64.8 65.3 62.5 BMI (kg/m 2 ) 35.9 33.5 28.6 24.5 35.9 32.3 28.5 23.2 UST Mean SS (m/s) 1423.1 1431.1 1445.8 1495.7 1427.8 1431.8 1447.8 1487.0 UST Total Volume (cm 3 ) 1462.0 906.2 744.9 389.3 1109.6 958.5 694.9 333.4 UST Dense SS (m/s) 1438.6 1454.1 1474.8 1518.6 1448.0 1455.7 1477.1 1511.2 UST Dense Volume (cm 3 ) 354.4 207.7 212.5 187.1 235.7 258.1 199.2 155.0 UST Fat SS (m/s) 1418.2 1425.0 1433.1 1473.4 1423.1 1424.3 1435.0 1465.4 UST Fat Volume (cm 3 ) 1107.6 698.6 532.4 202.2 873.9 700.4 495.6 178.4 UST Percent Density (%) 24.2 22.8 31.0 49.4 20.8 26.0 30.9 47.6 Volpara Total Breast Volume (cm 3 ) 2070.1 1261.1 949.6 552.8 1603.9 1235.5 937.2 383.9 r s = 0.880 (< 0.001) r s = 0.415 (< 0.001) Volpara Dense Breast Volume (cm 3 ) 68.7 56.6 92.2 92.8 54.3 72.4 95.9 72.6 Volpara Percent Density (%) 3.4 4.7 10.7 19.1 3.5 5.8 10.4 19.4 Density Groupings – UST Mean SS Density Groupings Radiologist BIRADS Volpara Grade a b c d a b c d Count 8 43 38 11 28 26 33 13 Age (years) 50.8 54.9 48.4 43.8 50.9 56.1 50.4 41.4 Weight (lbs) 220.9 201.2 172.0 138.7 217.2 194.2 171.8 129.2 Mean Mean Height (inches) 65.6 64.9 65.0 62.8 65.2 64.8 65.3 62.5 35.9 33.5 28.6 24.5 35.9 32.3 28.5 23.2 BMI (kg/m 2 ) 1427.8 a 1423.1 a UST Mean SS (m/s) 1423.1 1431.1 1445.8 1495.7 1427.8 1431.8 1447.8 1487.0 b b 1431.8 1431.1 UST Total Volume (cm 3 ) 1462.0 906.2 744.9 389.3 1109.6 958.5 694.9 333.4 1447.8 c 1445.8 c UST Dense SS (m/s) 1438.6 1454.1 1474.8 1518.6 1448.0 1455.7 1477.1 1511.2 1487.0 d 1495.7 d UST Dense Volume (cm 3 ) 354.4 207.7 212.5 187.1 235.7 258.1 199.2 155.0 UST Fat SS (m/s) 1418.2 1425.0 1433.1 1473.4 1423.1 1424.3 1435.0 1465.4 UST Fat Volume (cm 3 ) 1107.6 698.6 532.4 202.2 873.9 700.4 495.6 178.4 UST Percent Density (%) 24.2 22.8 31.0 49.4 20.8 26.0 30.9 47.6 Volpara Total Breast Volume (cm 3 ) 2070.1 1261.1 949.6 552.8 1603.9 1235.5 937.2 383.9 Volpara Dense Breast Volume (cm 3 ) 68.7 56.6 92.2 92.8 54.3 72.4 95.9 72.6 Volpara Percent Density (%) 3.4 4.7 10.7 19.1 3.5 5.8 10.4 19.4 5

  6. 6/8/2017 Density Groupings – Volpara PD Density Groupings – UST PD Mean Mean Mean Mean a a a a 3.4 3.5 24.2 20.8 b 4.7 b 5.8 b 22.8 b 26.0 c 10.7 c 10.4 c 31.0 c 30.9 d 19.1 d 19.4 d 49.4 d 47.6 Density Groupings – UST Dense SS Density Groupings – UST Skewness Mean Mean Mean Mean a 1438.6 a 1448.0 a 2.1 a 2.2 b b b b 1454.1 1455.7 1.9 1.5 c 1474.8 c 1477.1 c 0.8 c 0.8 d 1518.6 d 1511.2 d 0.0 d 0.0 6

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