Opportunities and Innovations in Digital Mammography John M. Sandrik, Ph.D. GE Healthcare Milwaukee, WI

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Opportunities and Innovations in Digital Mammography John M. Sandrik, Ph.D. GE Healthcare Milwaukee, WI john.sandrik@med.ge.com with many thanks to Vince Polkus, Advanced Applications Product Mgr. 1

Content Issues in Breast Cancer Management Exposure Control Image Processing Digital Breast Tomosynthesis (DBT) Detector Updates for DBT Contrast-Enhanced Digital Mammography FFDM - Ultrasound Fusion 2

Breast Cancer Management Opportunities Personalized Medicine Base screening regimens on personal risk profile Diagnose disease earlier, avoid unnecessary biopsies Base treatment on predicted effectiveness and tolerance Quickly assess treatment effectiveness GE Life Sciences Gene analysis and sequencing Protein, cellular analysis Drug discovery 3

Breast Cancer Management Opportunities GE Healthcare, Diagnostic Imaging 35% of cancers missed 70% in dense breasts 10% of those screened recalled, > 95% of recalls negative low specificity 80% biopsies are negative 1 in 3 breast cancer patients have undiagnosed multi-focal disease 1 in 20 those with breast cancer have undiagnosed bi-lateral disease Source: American Cancer Society, 2004 4

Breast Cancer Management Solutions Role of Digital Mammography 2000: FFDM enters market via PMA on the basis of non-inferiority to film mammo. 2005: ACRIN-DMIST confirms overall similarity to film mammography plus benefit for sub-populations. Now : Do procedures with FFDM that are impractical, impossible with film. 5

AOP Automatic Optimization of Parameters Re-designed for digital imaging Optimize Signal Diff. / Noise, not Contrast Effectiveness in dense breasts Mo / Mo ; Rh / Rh 6

Development of Digital AOP Ca 20 mg/cm² Skin Gland/Fat Skin Entrance Air-Kerma (Composition) S BG S µcal Signal difference to noise ratio of micro-calcification Average glandular dose (AGD) For each thickness and composition, adjust track, filter, kvp, and mas to find best SDNR at a given AGD. 7

Optimization Results: SDNR vs AGD iso-dose 2 cm Optimum SDNR at AGD for 2, 4, 6, 8 cm SDNR iso-sdnr 4 cm 6 cm 8 cm Next step: Find the best operating point on each curve AGD 8

Selection of Operating Points SDNR Max AGD Min SDNR 2 cm 4 cm 6 cm 8 cm Optimum SDNR at AGD for 2, 4, 6, 8 cm Solution: Provide set of trajectories Offer different levels of IQ/Dose compromise Respect IQ and Dose constraints AGD 9

AOP Evolution Senographe 2000 D Mo / Mo, 26 kvp, 125 mas Typical AOP CNT mode film-like 79% Phantom Imaging Seno DS, Essential Rh / Rh, 29 kvp, 56 mas Typical AOP STD mode digital Mo/Mo Mo/Rh Rh/Rh 20% Optimization drives to selection of Rh/Rh for most patients 1% 10

Image Processing Optimize display independent of acquisition Optimize image resolution, contrast Optimize use of display s dynamic range Minimize operator intervention with display 11

Pre-Processing Offset and Gain Correction FineView 12

FineView Operates on raw images. Compensates for the detector MTF. Compensation is dose-dependent. May produce unexpected results in quantitative measurements, e.g., noise vs. dose. 13

Post-Processing Auto-contrast Tissue Equalization Premium View 14

Tissue Equalization Local contrast Effect of TE processing Display dynamic range Signal Profile Compressed breast Breast tissue visible from chest wall to skin line Preservation of anatomical structures 15

Tissue Equalization Original Tissue Equalization Enhances visualization of the skin line Contrast similar to film

Premium View Effect of contrast enhancemen t Signal Profile Compressed breast Local contrast Effect of TE processing Display dynamic range Automatic local contrast optimization across entire image Breast tissue visible from chest wall to skin line Preservation of anatomical structures Increased contrast 17

Premium View How it Works Low Pass Weighted Low Pass Baseline Image High Pass Weighted High Pass PV Image 18

Premium View Tissue Equalization Premium View PV equalizes background and enhances local contrast in high and low exposure regions Minimizes need for windowing & leveling

The following devices are investigational and have not been approved for sale within the United States by the US Food and Drug Administration (FDA). These devices may or may not be commercialized in the future 20

Digital Breast Tomosynthesis Unmet Needs 30%-50% Cancers in dense breast tissue missed with 2D mammography High inter-observer variability missed cancers >95% screening recalls are negative No direct 3D localization Clinical Value Increased clinical accuracy diagnostic confidence Less observer variance Reduced patient anxiety with fewer recalls Direct 3D localization Promising imaging application for screening and diagnosis of cancer 21

DBT Reveals Occult ILC 2D FFDM Tomosynthesis Slice Cyst Images courtesy of Drs. Di Maggio & G Gennaro, Istituto Oncologico Veneto I.R.C.C.S. - Padova, Italia Lobular Carcinom a 22

DBT Image Quality Factors FFDM IQ Drivers Beam Quality Radiation Dose Additional DBT IQ Drivers Aperture Angle Number Exposure s Projection Dose Detector Properties 2D Image Processin g Image Display 3D Display Tools Sweep Time Pixel Readout 3D Recon Algorithm 23

DBT Challenges DBT Patient dose to be ~ same as 2D mammo. Number of projections ~ 10-20 Dose/projection <~ 1/10 dose for 2D mammo. Need low-noise detector Compression time ~ same as 2D mammo. Need fast read-out, low-lag detector Image processing time 10X more from seconds to minutes Softcopy workflow and productivity > 10X more images from 4-6 to 100-200 Transmission & archival 25X more from 60MB to 1,500MB 24

Detector Prepare for DBT 25

Detector Operation X-Ray Photons Cesium iodide converts x-rays to light, crystal acts as light pipe. CsI Light Photodiode converts light to electric charge Charge at each pixel read out by low-noise electronics and converted to digital data Amorphous Silicon Panel (Diode + TFT) Read-out and A/D electronics Electrons 26

Detector Updates Thinner Graphite Cover Decrease x-ray attenuation Slight increase in DQE Thicker CsI Scintillator Increase x-ray conversion Increase DQE Larger panel size, 24 x 31 cm 2 Coverage for oblique incidence Storage capacitor added Increase dynamic range Revised panel circuitry Increase readout rate Decrease noise Incident X-rays Transmitted X-rays Light 27

Senographe Essential DQE 14X drop in detector exposure; only 7% drop in L.F. DQE Albagli, SPIE 2005 28

Contrast Enhanced Digital Mammography (CEDM) Screening high-risk women Staging, determining extent of disease Problem solving Therapy planning, response monitoring 29

Two Imaging Methods Temporal Subtraction Dual-Energy Subtraction Contrast uptake Exposures lesion tissue difference Contrast uptake Exposures n exposures, 1 energy, few minutes time 2 exposures, 2 energies, ~ same time time 30

2D Temporal Subtraction t = 0 s t = 60 s t = 120 s t = 180 s Technique : Mo/Cu, 45 kv, 100 mas Period: T = 60 s Investigational program. Limited by US federal law to investigational use. Images courtesy of Charite 31

Dual-Energy Subtraction Dual-Energy Sub. Conventional FFDM Dual-Energy Sub. RMLO 2 min Images courtesy of Dr Dromain, Institut Gustave Roussy Villejuif, France RCC 4 min Dual-energy more reproducible avoids motion artifacts 32

FFDM - Ultrasound Fusion Unmet Needs 30%-50% Cancers in dense breast tissue missed with mammography Some cancers provide low X-Ray contrast or differentiation Ultrasound technique manual, operatordependent & time consuming Clinical Value Increased diagnostic confidence & accuracy Reduced patient anxiety with fewer recalls Improved workflow 33

FFDM/US Fusion Mammography Ultrasound FFDM / US Fusion + = + High resolution + High sensitivity + Microcalcification detection But: - Low specificity for mass lesions + High specificity (i.e., cysts vs. solid) + 3D imaging But: - Operator dependent - Can t visualize microcalcifications Best of both modalities Image registration Real-time imaging No operator dependence 34

Thank You 35