DOUG LAKE, MD, MRMD (MRSC) RADIOLOGIST, MCFARLAND CLINIC, PC ADJUNCT CLINICAL ASSISTANT PROFESSOR, DEPARTMENT OF RADIOLOGY, STANFORD HEALTH CARE

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1 DOUG LAKE, MD, MRMD (MRSC) RADIOLOGIST, MCFARLAND CLINIC, PC ADJUNCT CLINICAL ASSISTANT PROFESSOR, DEPARTMENT OF RADIOLOGY, STANFORD HEALTH CARE ADVANCES IN DIAGNOSTIC IMAGING

2 DISCLOSURES I own shares in the following companies through mutual funds which are utilized in medical practice and/or health care. Two of these companies (*) are directly mentioned in this presentation. *General Electric (GE) (0.67% of portfolio)* *Hologic, Inc. (0.09% of portfolio)* UnitedHealth Group Inc (0.74%) Allergan (0.50%) Intuitive Surgical Inc (0.48%) New Link Genetics (0.26%) Medtronic (0.19%) McKesson (0.04%)

3 OVERVIEW 3D breast tomosynthesis Tumor Response Assessment Radiation dose reduction project Hemangioma or something else?

4 HEMANGIOMA Benign tumor composed of multiple vascular channels lined by endothelial cells supported by thin fibrous stroma Best diagnostic clues: On US, well-defined, uniformly hyperechoic mass. May see posterior acoustic enhancement. On CT, peripheral nodular enhancement on arterial phase scan with slow, progressive, centripetal enhancement isodense to vessels. On MRI: Very T2 hyper intense, with postgadolinium nodular progressive enhancement isodense to vessels Images from StatDx, Michael Federle, MD FACR

5 HEMANGIOMA Benign tumor composed of multiple vascular channels lined by endothelial cells supported by thin fibrous stroma Best diagnostic clues: On US, well-defined, uniformly hyperechoic mass. May see posterior acoustic enhancement. On CT, peripheral nodular enhancement on arterial phase scan with slow, progressive, centripetal enhancement isodense to vessels. On MRI: Very T2 hyper intense, with postgadolinium nodular progressive enhancement isodense to vessels Images from StatDx, Michael Federle, MD FACR

6 HEMANGIOMA Benign tumor composed of multiple vascular channels lined by endothelial cells supported by thin fibrous stroma Best diagnostic clues: On US, well-defined, uniformly hyperechoic mass. May see posterior acoustic enhancement. On CT, peripheral nodular enhancement on arterial phase scan with slow, progressive, centripetal enhancement isodense to vessels. On MRI: Very T2 hyper intense, with postgadolinium nodular progressive enhancement isodense to vessels Images from StatDx, Michael Federle, MD FACR

7 HEMANGIOMA?

8 HEMANGIOMA?

9 A. Hemangioma B. Hepatocellular carcinoma C. Metastases from unknown primary malignancy D. Focal nodular hyperplasia E. Hepatic cyst

10 DIGITAL BREAST TOMOSYNTHESIS Approximately 231,840 new cases of invasive breast cancer and 40,290 breast cancer deaths expected in Mammographic screening can reduce breast cancer deaths by 30% 2 Digital mammography (DM) provide a two-dimensional image of a three-dimensional structure and superimposition of normal tissue can obscure masses or other important features of malignancy 3 1 : DeSantis CE, Fedewa SA, Sauer AG, et al (2016). Breast Cancer statistics, 2015: Convergence of incidence rates between black and white women. CA: A Cancer Journal for Clinicians, 66: : Tabar L, Vitak B, Chen TH, et al. Swedish Two-County Trial: impact of mammography screening on breast cancer mortality during 3 decades. Radiology 2011; 260 (3): : Roth RB, Maidment AD, Weinstein SP, et al. Digital Breast Tomosynthesis: Lessons Learned from Early Clinical Implementation. Radiographics 2014; 34: E89-E102.

11 DIGITAL BREAST TOMOSYNTHESIS DBT is a better mammogram Multiple low dose projection x-ray images are obtained along an arc 1 X-ray tube pivots in an arc of varying degrees (15-50) 1 3-dimensional DBT images are reconstructed from projection images by mathematical equation (FBP or IR) 1 In all manufacturers, multiple 2D images are created in thin 1 mm increments and available for display 1 1 : Roth RB, Maidment AD, Weinstein SP, et al. Digital Breast Tomosynthesis: Lessons Learned from Early Clinical Implementation. Radiographics 2014; 34: E89-E102.

12 TRADITIONAL 2D DIGITAL MAMMOGRAPHY

13 DIGITAL BREAST TOMOSYNTHESIS From: Peppard HR, Nicholson BE, Rochman CM, et al. Digital Breast Tomosynthesis in the Diagnostic Setting: Indications and Clinical Applications. RadioGraphics 2015; 35: Roth RB, Maidment AD, Weinstein SP, et al. Digital Breast Tomosynthesis: Lessons Learned from Early Clinical Implementation. Radiographics 2014; 34: E89-E102.

14 DIGITAL BREAST TOMOSYNTHESIS Multiple low dose projection x-ray images are obtained along an arc. X-ray tube pivots in an arc of varying degrees (15-50). 3-dimensional DBT images are reconstructed from projection images.

15 DIGITAL BREAST TOMOSYNTHESIS 15 projection images x Filtered Back Projection (FT) = 1 mm image set through the breast.

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19 DIGITAL BREAST TOMOSYNTHESIS Largest prospective trial of patients comparing digital mammography with digital breast tomosynthesis 15% reduction in recall rate 1 27% increase in cancer detection rate 1 Similar to another trial 15% reduction in recall rate 2 29% increase in cancer detection rate 2 1 Skaane P, Bandos AI, guilin R, et al. Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. Radiology 2013; 267 (1): Friedewald SM, Rafferty EA, Rose SL, et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA 205; 311(24):

20 DIGITAL BREAST TOMOSYNTHESIS Breast cancer screening; looking for mass, calcifications or architectural distortion Architectural distortion much better seen at DBT 268 BI-RADS 4 or 5 screening detected lesions with DM and DBT 3 7% (19 of 268) were occult at DM and only seen at DBT 3 10 of 19 (53%) were invasive breast cancers 3 7 of 10 ILC, 3 of 10 IDC 3 3 : Ray KM, Turner E, Sickles EA, Joe BN. Suspicious findings at digital breast tomosynthesis occult to conventional digital mammography: imaging features and pathology findings. Breast J 2015;21(5):

21 CC DM (left) and CC DBT (right) images demonstrate architectural distortion visible in the lateral breast on DBT im From: Strategies to Increase Cancer Detection: Review of True-Positive and False-Negative Results at Digital Breast Tomosynthesis Screening, Radiographics 2016; 36:

22 Pathology: 6 cm invasive lobular carcinoma. From: Strategies to Increase Cancer Detection: Review of True-Positive and False-Negative Results at Digital Breast Tomosynthesis Screening, Radiographics 2016; 36:

23 DIGITAL BREAST TOMOSYNTHESIS Quasi-three-dimensional information from DBT allows triangulation of subtle one-view-only lesions so that further targeted imaging (US>MRI) is possible. In a study of 115 malignant lesions, 35% were better or only seen on DBT CC view whereas only 11% were better or only seen on MLO view 4 Another study of 34 mixed benign and malignant lesions, 15% were better seen at CC DBT 5 4 Beck N, Butler R, Durand M, et al. One-view versus two-view tomosynthesis: a comparison of breast cancer visibility in the mediolateral oblique and craniocaudal views. Presented at the annual meeting of the American Roentgen Ray Society, Washington, DC, April Rafferty EA, Niklason L, Jameson-Meehan L. Breast tomosynthesis: one view or two? [abstr]. In: Radiological Society of North America scientific assembly and annual meeting program. Oak Brok, Ill: RSNA, 2006; 225.

24 DIGITAL BREAST TOMOSYNTHESIS Pathology results: Intermediate grade invasive ductal carcinoma. From: Strategies to Increase Cancer Detection: Review of True-Positive and False-Negative Results at Digital Breast Tomosynthesis Screening, Radiographics 2016; 36:

25 DIGITAL BREAST TOMOSYNTHESIS From: Strategies to Increase Cancer Detection: Review of True-Positive and False-Negative Results at Digital Breast Tomosynthesis Screening, Radiographics 2016; 36:

26 Digital Breast Tomosynthesis Screening, Radiographics 2016; 36: ADVANCES IN DIAGNOSTIC IMAGING DIGITAL BREAST TOMOSYNTHESIS Pathology results: Intermediate grade invasive ductal carcinoma with DCIS. From: Strategies to Increase Cancer Detection: Review of True-Positive and False-Negative Results at

27 DIGITAL BREAST TOMOSYNTHESIS Many trials and data, but the biggest was published in 2014 in JAMA 6 Breast Cancer Screening Using Tomosynthesis in Combination with Digital Mammography 454,850 exams Period 1: (Digital mammography) Period 2: (3D breast tomosynthesis + digital mammography) Major outcomes: Increased cancer detection rate: 4.2 to 5.4 per 1000 Decreased callback rate: 107 to 91 per 1000 (ie, 10.7% to 9.1%) 6 Friedewald SM, Rafferty EA, Rose SL, et al. Breast Cancer Screening Using Tomosynthesis in Combination with Digital Mammography. JAMA 2014;311(24):

28 DIGITAL BREAST TOMOSYNTHESIS McFarland Clinic Experience Compared our final year at full field digital mammography (2011) to our most recent complete year of DBT (2015) in a manner identical to the 2014 JAMA article (2011 vs 2012). Paper does not specify sites, but authors from: Caldwell Breast Center Park Ridge IL, MGH Boston MA, TOPS breast center Houston TX, Solis Women s Health Dallas TX, Yale New Haven CN, Case Western Reserve Cleveland OH, Washington Radiology Associates Fairfax VA, Radiology Associates of Hollywood FL, Albert Einstein Health Care Network Philadelphia PA, Evergreen Breast Health Center Kirkland WA, Sanford Breast Health Institute Sioux Falls SD, Sally Jobe Denver CO, Lincoln Breast Health Phoenix AZ, ICON Clinical Research San Francisco CA, University of Pennsylvania Philadelphia PA

29 DIGITAL BREAST TOMOSYNTHESIS - MCFARLAND EXPERIENCE Site # radiologists Academic or nonacademic Period 1 cases Period 2 cases Recall rate digital (%) Recall rate DBT (%) Cancer detection digital per 1000 Cancer detection DBT per A N A A N N N N N A N A N Study average A 8N McFarland 8 N

30 DIGITAL BREAST TOMOSYNTHESIS - MCFARLAND EXPERIENCE Site # radiologists Academic or nonacademic Period 1 cases Period 2 cases Cancer detection digital per 1000 Cancer detection DBT per 1000 Recall rate digital (%) Recall rate DBT (%) Study average A 8N McFarland 8 N % (+15%, +15%) -36% (-27%, -29%)

31 6 Friedewald SM, Rafferty EA, Rose SL, et al. Breast Cancer Screening Using Tomosynthesis in Combination with Digital Mammography. JAMA 2014;311(24):

32 1 Harvey JA, Mahoney MC, Newell MS, et al. ACR Appropriateness Criteria Palpable Breast Masses. Journal of the American College of Radiology November 2016 Vol. 13, Issue 11, e31 e42

33 Journal of the American College of Radiology November 2016 Vol. 13, Issue 11, e31 e yo: Ultrasound followed by mammogram for area of palpable concern in age if there is no corresponding abnormality found by the ultrasound after radiologist has reviewed the ultrasound. <18 yo: Ultrasound only. Mammogram performed only if advocated for by the patient/parents/guardian after discussion with the radiologist. 1 Harvey JA, Mahoney MC, Newell MS, et al. ACR Appropriateness Criteria Palpable Breast Masses.

34 MRI Abdomen without and with gadolinium from an outside institution 2/11/2016

35 A. Hemangioma B. Hepatocellular carcinoma C. Metastases from unknown primary malignancy D. Focal nodular hyperplasia E. Hepatic cyst

36 PET-CT McFarland Clinic 5/26/2016

37 MRI Abdomen without and with gadolinium McFarland Clinic 11/2016.

38 TUMOR RESPONSE ASSESSMENT Response Evaluation Criteria In Solid Tumors (RECIST) First published February 2000 Most recently revised 2009 (RECIST 1.1) Standardized assessments Complete response/remission (CR) Partial response (PR) Progression of disease (PD) Stable disease (SD) 1 Tirkes T, Hollar MA, Tann M, et al. Response Criteria in Oncologic Imaging: Review of Traditional and New Criteria. RadioGraphics 2013; 33:

39 New Criteria. RadioGraphics 2013; 33: ADVANCES IN DIAGNOSTIC IMAGING RECIST HOW IT WORKS RECIST 1.1 Lesions 5/2 Measurement LA (SALN) PD/PR 20%/30% New lesions PD 1 Tirkes T, Hollar MA, Tann M, et al. Response Criteria in Oncologic Imaging: Review of Traditional and

40 New Criteria. RadioGraphics 2013; 33: ADVANCES IN DIAGNOSTIC IMAGING RECIST HOW IT WORKS Target Non target New lesion Overall CR CR No CR PR Non PD No PR SD Non PD No SD PD Yes or no Yes or no PD Any PD Any PD Any Any Yes PD 1 Tirkes T, Hollar MA, Tann M, et al. Response Criteria in Oncologic Imaging: Review of Traditional and

41 RECIST HOW IT WORKS -30% = PR +20% = PD SD = + 4% NADIR baseline follow up 1 follow up 2 follow up 3 SD = STABLE DISEASE PD = PROGRESSIVE DISEASE PR = PARTIAL RESPONSE CR = COMPLETE REMISSION

42 TUMOR RESPONSE ASSESSMENT Criteria RECIST 1.1 PERCIST 1.0 Cheson Lugano Choi NRC/Lee (New Response Criteria) RANO (Response Assessment in Neuro-Oncology) MASS (Morphology, Attenuation, Size, Structure) irrc/irrecist mrecist Tumor/Modality Most tumors PET PET Diffuse Large B-cell Lymphoma (DLBCL) GIST NSCLC Glioblastoma RCC Melanoma HCC

43 New Criteria. RadioGraphics 2013; 33: ADVANCES IN DIAGNOSTIC IMAGING RECIST 1.1 VS LUGANO RECIST 1.1 Lugano Lesions 5/2 6 Measurement LA or (SALN) LA x SA = PPD PPD1 + PPD2 + etc = SPD CR Disappearance of target & <10mm LNSA PD/PR +20%/-30% <1.5 cm LNLA & disappearance of non-nodal dz +50% & +0.5(<2cm) or +1(>2cm)/-50% New lesions PD PD PET assessment No (PERCIST 1.0) Yes 1 Tirkes T, Hollar MA, Tann M, et al. Response Criteria in Oncologic Imaging: Review of Traditional and

44 1 Tirkes T, Hollar MA, Tann M, et al. Response Criteria in Oncologic Imaging: Review of Traditional and New Criteria. RadioGraphics 2013; 33: ADVANCES IN DIAGNOSTIC IMAGING TUMOR RESPONSE ASSESSMENT Limitations Inconsistent measurements between readers and even with same reader 1 Difficulty with measuring illdefined lesions 1

45 1 Tirkes T, Hollar MA, Tann M, et al. Response Criteria in Oncologic Imaging: Review of Traditional and New Criteria. RadioGraphics 2013; 33: ADVANCES IN DIAGNOSTIC IMAGING TUMOR RESPONSE ASSESSMENT Limitations Inconsistent measurements between readers and even with same reader 1 Difficulty with measuring illdefined lesions 1

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47 A. Hemangioma B. Hepatocellular carcinoma C. Metastases from unknown primary malignancy D. Focal nodular hyperplasia E. Hepatic cyst

48 RADIATION DOSE REDUCTION PROJECT CT abdomen and pelvis without contrast for renal colic symptoms Guidance from American College of Radiology states these exams should be performed with an average dose-lengthproduct (DLP) of 200 mgy-cm (3 msv). Guidance issued in ACR Dose Registry analysis in 2013 showed significant heterogeneity nationwide regarding adoption.

49 What is the lowest minimum dosing that can cause harm? 100 mgy = 100 msv

50 What is the lowest minimum dosing that can cause harm? 0.1 Sv = 100 msv

51 Minimum DLP Mean DLP Maximum DLP ,435 2,618 2,787 Red line: Average dose from 55 patients imaged on the 6 CT scanners surveyed. (DLP 964.9, approx 14.5 msv) ,657 1,494 1,363 1,205 1,130 1, MGMC GE Lightspeed 16 CT1 MGMC GE Lightspeed 64 CT2 McF Ames Toshiba Aquilon McF Marshalltown Toshiba Aquilon CIH GE Lightspeed CIG GE Optima 660 Yellow line: Midwest average from 14,642 exams compiled from by ACR dose registry (DLP 781, approx 11.2 msv). Orange line: National average from 49,903 exams compiled from by ACR dose registry (DLP 746, approx 11.2 msv). Green line: Recommended average for these exams by ACR (DLP=200, 3 msv) DLP approximates 45 msv DLP approximates 14.5 msv. 400 DLP approximates 6 msv. 200 DLP approximates 3 msv.

52 Minimum DLP Mean DLP Maximum DLP data ,787 2,618 2,435 1,657 1,494 1,363 1,205 1,053 1, MGMC GE Lightspeed 16 CT1 MGMC GE Lightspeed 64 CT2 McF Ames Toshiba AquilonMcF Marshalltown Toshiba Aquilon CIH GE Lightspeed CIG GE Optima 660 Red line: Average dose from 55 patients imaged on the 6 CT scanners surveyed. (DLP 964.9, approx 14.5 msv) Yellow line: Midwest average from 14,642 exams compiled from by ACR dose registry (DLP 781, approx 11.2 msv). Orange line: National average from 49,903 exams compiled from by ACR dose registry (DLP 746, approx 11.2 msv). Green line: Recommended average for these exams by ACR (DLP=200, 3 msv) data ,321 1,224 Minimum DLP Median DLP Mean DLP Maximum DLP MGMC GE Lightspeed 16 CT1 MGMC GE Lightspeed 64 CT2 McF Ames Toshiba Aquilon McF Marshalltown Toshiba Aquilon CIH GE Lightspeed CIG GE Optima 660 Yellow line: Midwest average from 14,642 exams compiled from by ACR dose registry (DLP 781, approx 11.2 msv). Orange line: National average from 49,903 exams compiled from by ACR dose registry (DLP 746, approx 11.2 msv). Red line: Average dose from 55 patients imaged on the 6 CT scanners surveyed. (DLP 690, approx 10.3 msv) Initial goal: We wanted to achieve an average of 2x the recommended ACR average (DLP=400, 6 msv). Green line: Recommended average for these exams by ACR (DLP=200, 3 msv).

53 A. Hemangioma B. Hepatocellular carcinoma C. Metastases from unknown primary malignancy D. Focal nodular hyperplasia E. Hepatic cyst

54 Hemangiomas and a breast carcinoma met - Both previously treated with Avastin

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