1. Meta Imaging Solutions Patient centered innovations Introduces:

2. The Chrysalis* breast displacement management system For breast radiation dose reduction and image improvement * Patent pending

3. Perspective on radiation dose Increased use of CT imaging – Increased utilization in general – 3D imaging applications – Expanded indications including CTCA PE protocol Chests CT Urography

4. Perspective on radiation dose Lifetime attributable risk of cancer from a single CTCA Scan(Einstein, et al, JAMA 298(3):317-323.) – 20 yr. old--0.70%-women, 0.15%-men – 40 yr. old--0.35%-women, 0.099%-men – 60 yr. old--0.22%-women, 0.081%-men

5. Lifetime attributable risk of Cancer Einstein, et al, JAMA 298(3):317-323.

6. Chrysalis, perspective for CTCA Cardiovascular disease is increasing in prevalence – Aging Baby Boomers mean more elderly patients – Increasing rates of obesity – Heart disease is the leading cause of death in women CT Coronary Angiography developed to non- invasively image the coronary arteries – Images are excellent and improving – Radiation dose to the breasts in women is significant, approximating 20-25 mammograms Limited scan plane to visualize the heart

7. Chrysalis, perspective for Abdominal CT CT Abdomen is a common CT examination – The breasts are in the imaging plane on most Abdominal CT examinations in women – CT Abdomen is relatively common in young women because of the high incidence of abdominal pain – Bismuth shielding is used to decrease breast radiation dose, about 35-40% but the breasts remain in the imaging field and produce imaging artifact

8. Chrysalis advantages – Breast displacement upwards Away from the abdomen for complete displacement out of the imaging plane Out of the imaging plane for CT Coronary Angiography, particularly the peri-areolar and upper outer quadrants, with effectiveness of displacement dependent on the breast size and density Potentially useful for CT for Pulmonary Embolism in young women

9. Chrysalis advantages – Comfortable – External lead shielding can be added to further improve dose reduction out of the imaging plane – Adaptable to a wide range of patient sizes – Dose reductions apply to all imaging techniques such as prospective gating and 256-slice CT

10. Breast dose reduction strategies for CT imaging CT Coronary angiography – Prospective gating – Partial volume scanning – Bismuth shielding – Automatic attenuation correction – Breast displacement/external shielding-Chrysalis Chest CT – Partial volume scanning – Automatic attenuation correction – Bismuth shielding – Chrysalis not used-scan plane too large

11. Breast dose reduction strategies for CT imaging CT Abdomen – Automatic attenuation correction – Bismuth shielding – Breast displacement/external shielding-Chrysalis

12. Breast dose reduction strategies for CT imaging – Automatic attenuation correction Widely available on all scanners No reduction in image quality – Prospective gating for CTCA Limited availability – Bismuth shielding 35-45% dose reduction Breasts in imaging plane Artifacts in imaging plane – Breast displacement/external shielding-Chrysalis Breasts out of imaging plane Decrease in artifacts in large breasted women Median dose reductions (CTCA pilot study): – Inferior lateral quadrants: 32% – Peri-areolar: 90% – Upper outer quadrants: 95% External shielding can be added for additional dose reduction Reduction in dose additive to CT scanner based reduction strategies

13. Breast dose reduction strategies for CT imaging – Breast displacement/external shielding-Chrysalis Useful in exams where breast displacement practical – CT Abdomen – CT coronary angiography – Potentially for Chest CT for Pulmonary Embolism Breasts are displaced upwards out of the imaging plane Optimal displacement of peri-areolar and upper-outer quadrants – Largest volume of radio-sensitive breast tissue Less tissue to traverse, increased photons at detectors Decreased artifacts in large breasted women Additive to other dose reduction strategies

14. Breast dose reduction strategies for CT imaging Chrysalis pilot study – 10 patients 5 control 5 displaced by Chrysalis – Patient demographics Body mass index Bra cup size – OSL dosimeters placed in 4 locations in breasts Inferior margin at chest wall Inferior quadrant midway between nipple and chest wall Nipple Upper quadrant midway between nipple and chest wall – Patient experience wearing the Chrysalis evaluated with post- procedural questionnaire

15. Breast dose reduction strategies for CT imaging Chrysalis pilot study-results – Questionnaire responses No shortness of breath while wearing Chrysalis No discomfort while wearing the Chrysalis – Responses typically were that it was quite comfortable All patients would choose to wear the Chrysalis if it is shown to be effective – Sample responses in control group “I would really like to wear the device.” “If I come back tomorrow, could I wear the Chrysalis?” All expressed a strong interest in being in the other group wearing the Chrysalis

16. Breast dose reduction strategies for CT imaging Chrysalis pilot study results – BMI mean Control group-29 Chrysalis group-43 – Bra cup size mean Control group-B Chrysalis group-D

17. Breast dose reduction strategies for CT imaging Chrysalis pilot study results – Radiation dose reduction-median Inferior margin – -1.6% left, -23.2% right Inferior quadrant – -30.8% left, -33.4% right Peri-areolar (nipple) – -87.8% left, -92.4% right Upper quadrant – -95.2% left, -94.5% right

18. Breast dose reduction strategies for CT imaging Chrysalis pilot study results – Intra-subject comparisons between dose at inferior margin of the breast and upper quadrants. Upper quadrants – Control group » 6 of 10 measurements in the upper quadrants greater than inferior margin – Chrysalis group » Least dose reduction 77%, median 95.3% left, 94.0% right

19. Breast dose reduction strategies for CT imaging – Bismuth shielding Easily used Different sizes available Efficacy independent of breast size 35-45% dose reduction Breasts not displaced and remain in imaging plane Artifacts at periphery of imaging plane Reduction in photons through-out scan plane

20. % Dose Reduction Chrysalis

21. Responses to questionnaire after wearing the Chrysalis

22. Subject 6, BMI 42 Bra Cup size D Breasts in the scan plane, Subject in Control Group Chrysalis not used Scan plane

23. Subject 6, BMI 42, Bra cup size D Breasts in the imaging plane, control group not wearing the Chrysalis

24. Subject 7 BMI 43 Bra cup size DDD Breasts displaced upwards out of the scan plane by Chrysalis

25. Subject 7, BMI 43 Bra cup size DDD Breasts displaced upward out of scan plane Breasts displaced upwards out of the imaging plane by the Chrysalis

26. AP Topographic image comparisons between control and displaced group Subject 5, BMI 23, Bra cup BSubject 10, BMI 33, Bra cup D Fiducial marker Upper and lower margins of scan plane Scan plane, breasts difficult to see

27. Lateral topographic comparisons between control and displaced group Subject 6, Breasts not displaced, control group Subject 7, Breasts displaced by Chrysalis; note fiducial at top of Chrysalis.

28. Lateral Topographic image comparisons without(Left) and with(Right) Chrysalis Non-displaced, breasts in the imaging plane for CTCA With Chrysalis displacement, breasts out of the imaging plane for CTCA Nipple

29. Objective Image quality, matched subjects Subject 10, with ChrysalisSubject 5, non-displaced BMI3323 Bra cup sizeDB SD Pulmonary Artery, HU17.310523.1968 SD Left Ventricle, HU12.480121.6982 SD Right Ventricle, HU11.058716.4248 SD Aorta, HU13.327118.6049 SD Left Atrium, HU10.189723.3802 SD Fat at Chest Wall, HU10.76313.999 SD Left Ventric. Wall, HU8.591122.8901 SD Fat Adj. to Aorta, HU13.955537.6835 SD Fat Adj. to Pulm. Art., HU 14.437826.6073 Mean Standard Deviation12.4622.72 Percentage Improvement Subject with Chrysalis45.2%

30. Objective Image Quality, Matched Subjects Subject 8, with ChrysalisSubject 7, non-displaced BMI4342 Bra cup sizeDDDD SD Pulmonary Artery, HU24.890624. SD Left Ventricle, HU12.94841.3497 SD Right Ventricle, HU12.862830.5553 SD Aorta, HU22.044524.6378 SD Left Atrium, HU19.960826.676 SD Fat at Chest Wall, HU16.09438.8654 SD Left Ventric. Wall, HU13.059530.9426 SD Fat Adj. to Aorta, HU27.698635.2194 SD Fat Adj. to Pulm. Artery, HU 25.686632.1756 Mean ROI19.4731.56 Percentage Improvement Subject with Chrysalis38.3%

31. Left main, 0.5 mm thickness BMI 43 Bra cup size DDD

32. Axial Image comparisons, without and with Chrysalis Subject 6, BMI 42, D Cup Left Main, 0.5 mm recon without Chrysalis, note graininess of images and ill-defined edges Subject 7, BMI 43, DDD Cup Left Main, 0.5 mm recon with Chrysalis, note images less grainy and with sharper margins

33. Axial Image comparisons, without and with Chrysalis Subject 6, BMI 42, D Cup RCA, 0.5 mm recon without Chrysalis-fuzzy edges, grainy Subject 7, BMI 43, DDD Cup RCA, 0.5 mm recon with Chrysalis-sharp edges, smooth

34. Axial Image comparisons without and with Chrysalis Subject 5, BMI 23, Bra cup B Non-displaced control group, note less well-defined margins and inhomogeneous contrast –filled spaces Subject 10, BMI 33, Bra cup D Chrysalis displaced group, note sharp edges of LAD and smooth contrast-filled spaces

35. CT Abdomen, Need for Displacement

36. Breasts over-lapping upper abdomen- Note upper right lobe of liver, large amount of breast tissue, and bismuth shielding

37. CT Abdomen, note lower breasts over- lapping the upper abdomen

38. How much Breast dose reduction do you need?

39. Why leave the breasts in the imaging plane when they can be displaced?

40. Don’t expose the breasts, displace them instead Include the Chrysalis in your CT Dose reduction program

41. The Chrysalis breast displacement management system. Contact: Charles M Swaney, MD 573-886-8936(O) 573-864-2603(C)