DIGITAL MAMMOGRAPHY: PHYSICIAN’S PERSPECTIVE ACKNOWLEDGEMENTS • Thanks to: to: 2008 Annual AAPM Meeting Houston, TX July 31, 2008 JAY PARIKH, MD, FRCP(c), FRCP(c), CPE, FSBI, FACPE Medical Director Women’ Women’s Diagnostic Imaging Center Swedish Cancer Institute CREDENTIALS • Can spell digital • Have used a digital camera – AAPM • Special Thanks: Thanks: – Kalpana Kanal, Kanal, PhD, DABR CREDENTIALS • Certified by ABR, FRCP, ACR • Fellowship in breast imaging • Do 100% breast • Have a digital unit on site 1 It works! Thank You! DISCLOSURE • Hologic: Hologic: – NonNon-paid member, scientific advisory panel OBJECTIVES • (1) To review clinically relevant functional components of digital mammography. • (2) To introduce some of the advanced applications of digital mammography. • Thanks to: to: – Grady Hartzog, Hartzog, M.D. 2 OBJECTIVES OBJECTIVES • (1) To review clinically relevant functional components of digital mammography. • (3) To discuss some barriers to widespread clinical use of digital mammography. • (2) To introduce some of the advanced applications of digital mammography. • (4) To review data from clinical trials regarding digital mamography. mamography. OBJECTIVES • (3) To discuss some barriers to widespread clinical use of digital mammography. • (4) To review data from clinical trials regarding digital mammography. 3 DIGITAL MAMMOGRAPHY 2007 ACS STATS WHY DIGITAL? • 1 in 7 cumulative lifetime risk • >178,000 new invasive cancers • >40,000 deaths from breast cancer INTRODUCTION SCREENING RADIOLOGIST SMALLER CANCERS PRIMARY DIAGNOSTICIAN PATIENT SURVIVAL SFM: QED • Randomized control trials • 2 years before palpable • ACR, ACS, AMA TREATMENT OPTIONS 4 SFM - LIMITATIONS • • • • • DENSE BREAST MULTICENTRIC CA Mature technology FN 1010-30% Dense tissue PPV 55-40% Anything better? DIGITAL MAMMOGRAPHY WHY DIGITAL? FUNCTIONAL COMPONENTS 5 FUNCTIONAL COMPONENTS IMAGE ACQUISITION DIGITAL : • (1) Image Acquisition • (2) Image Processing • (3) Image Display SFM: ALL BY FILM! Photons --> --> Detector --> --> Electrical SFM: Photons --> --> Light --> --> Latent image IMAGE ACQUISITION DIGITAL : Photons --> --> Detector --> --> Electrical • dynamic range 1000:1 • higher contrast ; dense breast • spatial <= SFM 6 SECOND OPINION FOR CA++ SECOND OPINION FOR CA++ 7 IMAGE PROCESSING • Alter contrast • Alter brightness • Enlarge areas • Reduce repeats • Reduce radiation dose 8 IMAGE DISPLAY (1) Hard - copy Laser print film (2) Soft - copy Cathode ray tube monitor HARD COPY • • • • Installation printer Film expense Storage cost and space One window/level image • Tangible record • No processor errors 9 OPERATIONAL • Tech work station • Reading work station • Film comparisons • Storage area SOFT COPY • • • • • Expense of monitors Professional training Tech support Comparisons SFM viewboxes • Multiple windows • No digitizer for CAD 10 HARD COPY vs SOFT COPY • International Development Group • 28 images - histologically proven Ca++ and masses • 3 units (GE, Fischer, LoRad) LoRad) • 12 radiologists compared SFM to digitized FFD images Pisano E et al. Radiology 2000; 216: 820-830 LCD vs CRT HARD COPY vs SOFT COPY • • • • Screening: SFM preferred to digitized Masses: Printed digitals preferred to screening CA++: No processed digital preferred to SFM When digital images preferred to SFM, selected processing. – Thus, softsoft-copy display preferred. Pisano E et al. Radiology 2000; 216: 820-830 LCD vs CRT • Expensive • Luminescence • Lower weight • Grainy images • Life expectancy • Smaller volume • Technology for FFDM • Lesion conspicuity • Reduced heat load 11 DIGITAL MAMMOGRAPHY ADVANCED APPLICATIONS WHY DIGITAL? FUNCTIONAL COMPONENTS ADVANCED APPLICATIONS (1) Telemammography (2) CAD (3) New modalities Parikh JR. Digital Mammography: Current Capabilities and Obstacles. JACR 2005 TELEMAMMOGRAPHY • Rapid digital image transfer between sites • Enabled by softsoftcopy transfer Kelly M, Parikh JR, Shaw KK, Hallam PS. Mobile Digital Telemammography. Sem Breast Dis 2006 12 TELEMAMMOGRAPHY STRENGTHS • Mobile mammo - RT can check films • OffOff-site supervision and reads • OnOn-line reads • Expert reads in group • DoubleDouble-reads • Second opinions TELEMAMMOGRAPHY ISSUES • • • • • • Image transfer quality Lines for transfer Costs Patient privacy issues Liability Standards & guidelines CAD / SFM • • • • Digitized hardcopy software been around Been used with SFM 3 companies approved by FDA Retrospective / prospective studies – increased cancers – increased recalls; increased FP • Reimbursed 13 “DIGICAD” “DIGICAD” - ISSUES • Operational headaches • Direct softcopy software is key • Efficient • Less expensive? (No hardware) CAD / SFM - ISSUES • How many attorneys does it take to screw in a light bulb? • How many can you afford? – installation – process issues – professional training • • • Resistance by staff Reimbursement variable MedicoMedico-legal NEW IMAGING MODALITIES (1) Stereomammography (2) ContrastContrast-enhanced DM (3) Tomosynthesis (4) DualDual-energy subtraction 14 STEREOMAMMO • • • • >=2 images obtained at different angles Images fused together Perceive relative depth Similar to images of stereotactic biopsy CONTRASTENHANCED DM • • • • Angiogenesis = neovascularity Enhancement profile Similar to MRI Spatial resolution DM greater than MRI Angiogenesis: The Basics Genetic mutations cause a cell to become cancerous Small tumor Chemical signal Growing tumor Growing Capillaries Nutrients from blood Cancer cells migrate to other parts of the body Source: Time Magazine, May 1998 15 CONTRAST ENHANCED DIGITAL MAMMOGRAPHY • Adjunctive Imaging – Positive/Negative Predictive – Sens/Spec Sens/Spec • Extent of disease • High Risk Screening – Sens/Spec Sens/Spec – False + ???? Parikh JR, Porter BA ATL Case Studies CONTRASTENHANCED DM • Jong, Jong, Yaffe et al – ContrastContrast-enhanced Digital Mammography: Initial Clinical Experience – Radiology 2003; 228:842228:842-850 Digital XX-ray Breast Angiography • Outline of Procedure – – – scout image injection of 100mL Omnipaque 300 images 2 to 5 taken at times 1 min., 3 min., 5 min. and 7min. from start of injection • Lewin, et al – DualDual-Energy ContrastContrast-enhanced Digital Subtraction Mammography – Radiology 2003; 229:261229:261-268 • Image acquisition – Direct Subtraction – Dual Energy • Image Processing – registration – logarithmic subtraction – smoothing Courtesy : Yaffe / Parisky 16 Patient With Benign Lesion (Fibrocystic Change) Digital Subtraction Iodine Imaging of the Breast Precontrast Compressed Breast 1 min Scout PostContrast Contrast Agent T I1 I2 Logarithmic subtraction: lnI2 –lnI1 = t(µ−µ1) Courtesy : Yaffe / Parisky Enhancement Kinetics 30 25 Subtracted Images Linear subtraction: I2-I1 = I0e-µt(et(µ1−µ) − 1) 5 min Lesion Mean - Tissue Mean in I2 = I0e-µ(T-t)-µ1t I1 = I0e-µt 20 15 10 5 0 0 1 2 3 4 5 6 7 8 Time (minutes) Courtesy : Yaffe / Parisky Patient With Malignant Lesion (IDC) DUAL-SUBTRACTION 1 min Scout • Acquisition of 2 images in which effective energy of the detected radiation differs • Single exposure; stacked detectors Enhancement Kinetics 30 Subtracted Images Lesion Mean - Tissue Mean in 5 min • Mask undesirable irrelevant material • Preserve contrast in relevant structures 20 10 0 0 1 2 3 4 5 6 7 8 Time (minutes) Courtesy : Yaffe / Parisky 17 TOMOSYNTHESIS • Digital form of tomography • Minimal added time and added radiation • Rad source moves in a stepstep-wise arc above detector • Planes above and below are blurred – makes lesion conspicuous Courtesy: Hologic 18 Selenia Mammogram Biopsy proven cancer Selenia Tomosynthesis Selenia Mammogram Selenia Tomosynthesis Mammographically occult biopsy proven cancer 19 Selenia Mammogram Selenia Tomosynthesis Mammographically occult biopsy proven cancer Selenia Mammogram Selenia Tomosynthesis Benign. Superimposed parenchyma Selenia Mammogram Selenia Tomosynthesis Benign cyst that went to biopsy 20 Selenia Mammogram Selenia Tomosynthesis Benign cyst that went to biopsy, not visible in FFDM MLO DIGITAL MAMMOGRAPHY WHY DIGITAL? FUNCTIONAL COMPONENTS ADVANCED APPLICATIONS BARRIERS BARRIERS • • • • • • (1) (2) (3) (4) (5) (6) Cost Operational - space, setset-up Storage Resistance to change MQSA / FDA Clinical trials data Parikh JR. Digital Mammography: Current Capabilities and Obstacles. JACR 2005 21 COST • Unit, Plate • Ancillary – monitors – printer • Space / electrical • Service support • Professional Education OPERATIONAL OPERATIONAL • Tech work station • Reading work station • Film comparisons • Scheduling TECH ACQUISITION STATION 22 OPERATIONAL • Tech work station • Reading work station • Film comparisons • Storage area OPERATIONAL • Tech work station • Reading work station 23 STORAGE • 4 views = 3535-216 MB – CEDM – DIG TOMO • Compression techniques • Separation breast pixels • PACS CHANGE • Admins don’ don’t want the headache • MD’ MD’s resistant to soft copy monitors • MedicoMedico-legal issues • Only constant in health care is change MQSA / FDA • Each unit will have separate FDA/ MQSA requirements • Costs • “Silo effect” effect” CONSENSUS PANEL! Parikh JR, Fanus D. Implementing Digital Quality Control in a Breast Center. JACR 2004 24 DIGITAL MAMMOGRAPHY WHY DIGITAL? FUNCTIONAL COMPONENTS ADVANCED APPLICATIONS BARRIERS CLINICAL TRIALS CLINICAL TRIALS • RCT only way to prove reduction in mortality from early detection • Ethically not possible • Inferred by comparing SFM to FFD – like manufacturers to get FDA approval 25 CLINICAL TRIALS Trial Article FFDM n AGE PPV Detection Rate Recall Rate DMIST (455 days) 4945 40-69 (Screening) FFDM = 60% FFDM = 11.5% Colorado Radiology 2001; GE FFDM = 3.7%, SFM = 63% SFM = 13.8% 2000D 218:873-80 / Mass SFM = 3.2% Oslo I Oslo II ACRIN DMIST Modality Sensitivity Specificity PPV FFDM 0.49 0.97 0.12 SFM 0.35 0.98 0.07 0.47 0.97 0.10 FFDM = 0.62% FFDM = 4.6% (Biopsy) 3683 50-69 Radiology 2003; GE FFDM = 39%, SFM = 0.76% SFM = 3.5% 2000D 229: 877-884 SFM = 46% Women <50 Radiology 2004; GE 25263 45-69 (Abn Mammo) 50-69 232: 197-204 2000D 50-69 FFDM = 0.83% FFDM = 21.6% SFM = 0.54% SFM = 22.1% 45-49 45-49 FFDM = 0.27% FFDM = 7.1% SFM = 0.22% SFM = 7.4% Pre and perimenopausal FFDM SFM 0.38 0.98 0.09 Heterogeneously Dense or Dense FFDM 0.38 0.97 0.10 SFM 0.36 0.97 0.10 NEJM 2005; 353- Fischer 42760 40-70 , Fuji, GE, Hologic ? 50-69 FFDM = 3.8% SFM = 2.5% 45-49 FFDM = 3.7% SFM = 3.0% ? ? NEJM 2005; 353 DMIST (455 days) DMIST (455 days) Modality Sensitivity Specificity PPV FFDM Modality Sensitivity Specificity PPV FFDM 0.49 0.97 0.12 SFM 0.35 0.98 0.07 Pre and perimenopausal FFDM 0.47 0.97 0.10 Heterogeneously Dense or Dense 0.49 0.97 0.12 SFM 0.35 0.98 0.07 Pre and perimenopausal FFDM 0.47 0.97 0.10 SFM 0.38 0.98 0.09 SFM 0.38 0.98 0.09 Heterogeneously Dense or Dense FFDM 0.38 0.97 0.10 FFDM 0.38 0.97 0.10 SFM 0.36 0.97 0.10 SFM 0.36 0.97 0.10 Women <50 Women <50 NEJM 2005; 353 NEJM 2005; 353 26 DMIST (455 days) Modality Sensitivity Specificity OBJECTIVES PPV FFDM 0.49 0.97 0.12 SFM 0.35 0.98 0.07 Pre and perimenopausal FFDM 0.47 0.97 0.10 SFM 0.38 0.98 0.09 Heterogeneously Dense or Dense FFDM 0.38 0.97 0.10 SFM 0.36 0.97 0.10 Women <50 • (1) To review clinically relevant functional components of digital mammography. • (2) To introduce some of the advanced applications of digital mammography. NEJM 2005; 353 OBJECTIVES OBJECTIVES • (1) To review clinically relevant functional components of digital mammography. • (3) To discuss some barriers to widespread clinical use of digital mammography. • (2) To introduce some of the advanced applications of digital mammography. • (4) To review data from clinical trials regarding digital mamography. mamography. 27 IS FFDM READY FOR PRIME TIME? OBJECTIVES • (3) To discuss some barriers to widespread clinical use of digital mammography. • (4) To review data from clinical trials regarding digital mammography. • • • • Getting close..… close..…. DMIST helped Workflow issues Manufacturers stuck - need to see profits • But… But…. IT’S COMING!! Parikh JR. Digital Mammography: Current Capabilities and Obstacles. JACR 2005 USA - FFDM UNITS AND FACILITIES x 3 Courtesy Penny Butler, ACR/ FDA website 4 28 FIND X HERE IT IS! x 3 x 3 4 4 Thank You! 29 30