Mammography Clinical Applications - TiCEM - Summary

SIEMENS Healthineers TiCEM Titanium Contrast Enhanced Mammography Women’s Health English, March 2023 Unrestricted © Siemens Healthineers, 2023 Overview SIEMENS Healthineers • Introduction 3 • Background information 4 Contrast-enhanced imaging 04 Dual-energy mammography 11 SIEMENS .. Healthineers SIEMENS Healthineers SIEMENS Injection protocols and timing 18 Heatthingers Clinical evidence of contrast-enhanced mammography 24 Advantages and limitations 31 • Workflow and dose 33 • Clinical TiCEM cases 38 • Clinical studies with TiCEM 43 2 Unrestricted © Siemens Healthineers, 2023 Introduction SIEMENS Healthineers Contrast-enhanced mammography (CEM) is a morpho-functional imaging technique that uses • intravenous iodinated contrast agent Study ID: 1aaa042 • dual-energy mammography Contrast-enhanced mammography works because of • differences in contrast agent uptake (healthy breast tissue vs. malignant tissue) • differences in X-ray absorption (iodine vs. breast tissue) Low-energy (LE) image Recombined image (morphological) (functional) The products/features mentioned herein are not commercially available in all 3 countries. Their future availability cannot be guaranteed. Unrestricted © Siemens Healthineers, 2023 SIEMENS Healthineers calthineers TiCEM Contrast- enhanced imaging Click to add footnote 4 second line Unrestricted © Siemens Healthineers, 2023 Background information SIEMENS Healthineers Contrast-enhanced imaging Contrast agent • The contrast agent used in CEM is the same that’s used in CT imaging (iodine-based). • It differs from MRI, where gadolinium is used. • The contrast agent is not a tumor marker but rather reflects physiology/perfusion. O HO N N OH H OH OH HN O O Molecular structure of an iodine contrast agent The products/features mentioned herein are not commercially available in all 5 countries. Their future availability cannot be guaranteed. Unrestricted © Siemens Healthineers, 2023 Background information SIEMENS Healthineers Contrast-enhanced imaging How does contrast enhancement work? Accumulation of the contrast agent in the tissue leads to signal enhancement. The Capillary accumulation depends on the physiology: Cell • Blood flow • Volume percent of extravascular extracellular space Contrast agent • Permeability of the vessels (“leakiness”) Extravascular extracellular space 6 Unrestricted © Siemens Healthineers, 2023 Background information SIEMENS Healthineers Contrast-enhanced imaging Tumor angiogenesis Tumor angiogenesis is the growth of new VEGF production Blood-vessel growth Tumor growth blood vessels to provide nutrients and oxygen that tumors need to grow. This process is caused by the release of chemicals by the tumor and by host cells Tumor near the tumor. VEGF These new blood vessels have a high vessel permeability (“leakiness”). VEGF = vascular endothelial growth factor The products/features mentioned herein are not commercially available in all 7 countries. Their future availability cannot be guaranteed. Unrestricted © Siemens Healthineers, 2023 Background information SIEMENS Healthineers Contrast-enhanced imaging Goal of contrast-enhanced mammography (CEM) CEM aims to detect abnormalities/differences in Contrast enhancement contrast agent uptake in different breast tissues. 0 1 2 3 4 5 6 - Large feeding arteries Time (min) Tumor tissue (malignant) Breast tissue (glandular) 8 Unrestricted © Siemens Healthineers, 2023 Background information SIEMENS Healthineers Contrast-enhanced imaging Background parenchymal enhancement (BPE) Applies to both CE-MRI and CEM and Contrast enhancement fluctuates with1 • breast density • hormone levels (menopausal status, phase of the menstrual cycle in premenopausal women, hormone therapy, etc.) • radiation therapy 0 1 2 3 4 5 6 Large feeding arteries Time (min) Tumor tissue (malignant) Breast tissue (glandular) = BPE 1 Sogani J et al. (2017): Comparison of Background Parenchymal Enhancement at Contrast-enhanced Spectral Mammography and Breast MR Imaging. 9 The products/features mentioned herein are not commercially available in all countries. Their future availability cannot be guaranteed. Unrestricted © Siemens Healthineers, 2023 Background information SIEMENS Healthineers Contrast-enhanced imaging Background parenchymal enhancement BPE is usually present in a bilateral, symmetrical distribution.1 Increased BPE in CEM is associated with higher breast density.1,2 A B C D Left oblique (top) and CC (bottom) views showing examples of minimal, mild, moderate, and marked BPE, respectively. Reprinted from Savaridas et al.2 1 Sogani J, et al. (2017): Comparison of background parenchymal enhancement on contrast-enhanced spectral mammography and breast MR imaging. 2 Savaridas SL, et al. (2017): Could parenchymal enhancement on contrast-enhanced spectral mammography (CESM) represent a new breast cancer risk factor? 10 The products/features mentioned herein are not commercially available in all countries. Their future availability cannot be guaranteed. Unrestricted © Siemens Healthineers, 2023 SIEMENS Healthineers calthineers TiCEM Dual-energy mammography Click to add footnote 11 second line Unrestricted © Siemens Healthineers, 2023 Background information SIEMENS Healthineers Dual-energy mammography X-ray in mammography The shape of an X-ray spectrum depends on the design of the X-ray tube with an anode/filter combination. Filters Intensity Spectrum kV Anode X-rays Mo/W Mo/Rh/Ti Photon energy The products/features mentioned herein are not commercially available in all 12 countries. Their future availability cannot be guaranteed. Unrestricted © Siemens Healthineers, 2023 Background information SIEMENS Healthineers Dual-energy mammography X-ray attenuation depends on: Mass attenuation /g] • Material coefficient [cm2 • Energy 100 The higher the mass attenuation coefficient, the more X-ray absorption. 10 Iodine contrast agent: K-edge at 33.2 keV 1 Different iodine absorption below and above K-edge 0.1 10 20 30 40 50 60 Adipose tissue (ICRU-44) Photon energy [keV] Breast tissue (ICRU-44) Soft tissue (ICRU-44) Cortical bone Iodine 13 Unrestricted © Siemens Healthineers, 2023 Background information SIEMENS Healthineers Dual-energy mammography Dual-energy imaging refers to imaging a tissue Mass attenuation using two different energy spectra. coefficient [cm2 /g] Dual-energy mammography acquires two images; below (low energy) and above 100 (high energy) the K-edge of iodine. 10 1 - Acquisition of 0.1 low- high- 10 20 30 40 50 60 energy energy Adipose tissue (ICRU-44) Photon energy [keV] image image Breast tissue (ICRU-44) Soft tissue (ICRU-44) Cortical bone Iodine 14 Unrestricted © Siemens Healthineers, 2023 Background information SIEMENS Healthineers Dual-energy mammography Dual-energy imaging refers to imaging a tissue using two different energy spectra. • Dual-energy mammography acquires two Study ID: 1aaa042 images; below (low energy) and above. (high energy) the K-edge of iodine. • The low-energy image can be used for diagnosis and is similar to a normal full- field digital mammogram. • The high-energy image isn’t for diagnostic use; it’s used to reconstruct a “recombined image.” Low energy (LE) High energy (HE) The products/features mentioned herein are not commercially available in all 15 countries. Their future availability cannot be guaranteed. Unrestricted © Siemens Healthineers, 2023 Background information SIEMENS Healthineers Dual-energy mammography Dual-energy mammography provides a recombined image. The recombined image is • a weighted subtraction (HE - x*LE) that removes the anatomical noise • an iodine map, showing contrast agent uptake, indicative of tumor tissue Low energy (LE) High energy (HE) Recombined imageStudy ID: 1aaa042 The products/features mentioned herein are not commercially available in all 16 countries. Their future availability cannot be guaranteed. Unrestricted © Siemens Healthineers, 2023 Conclusion SIEMENS Healthineers Contrast-enhanced mammography (CEM) is a morpho-functional imaging technique that uses • intravenous iodinated contrast agent Study ID: 1aaa042 • dual-energy mammography Contrast-enhanced mammography works because of • differences in contrast agent uptake (healthy breast tissue vs. malignant tissue) • differences in X-ray absorption (iodine vs. breast tissue) Low energy (LE) image Recombined image (morphological) (functional) The products/features mentioned herein are not commercially available in all 17 countries. Their future availability cannot be guaranteed. Unrestricted © Siemens Healthineers, 2023 SIEMENS Healthineers calthineers TiCEM Injection protocols and timing Click to add footnote 18 second line Unrestricted © Siemens Healthineers, 2023 Background information SIEMENS Healthineers What if a customer asks about injection protocols? As a manufacturer of contrast-enhanced mammography equipment, we can’t recommend specific protocols. The responsibility for contrast-enhanced examinations, including the injection of contrast medium, lies in the hands of the radiologist. What Siemens Healthineers can offer: • “These guidelines state…” • “These injection protocols are described in the literature…” • “Our customers have good experiences with…” 19 Unrestricted © Siemens Healthineers, 2023 Background information SIEMENS Healthineers Use of contrast agent Please comply with the local operating procedures, guidelines, and safety measures for working with contrast agents. This covers: • Power injectors • Cannulation equipment: IV – cannulas, sterets, ESUR Guidelines ACR Manual saline, syringes, etc. on Contrast Agents On Contrast Media • Pre-heating device (to lower the viscosity of CA) European Society of Urogenital Radiology • Point-of-care device: blood test measuring eGFR to evaluate kidney function prior to scan 2023 • Contrast reaction treatment cart ACR Com Drugs and Contrast Media • Training of techs required 10.0 ACR RADIOLOGY QUALITY IS OUR IMADE 20 Unrestricted © Siemens Healthineers, 2023 Background information SIEMENS Healthineers IV (intravenous) iodinated contrast agent risks1 Hypersensitivity reactions • 2 in 10,000 will develop anaphylaxis reaction. • 0.02 to 0.04 percent are severe. • 1/100,000 to 1/170,000 will cause death. Post-contrast acute kidney injury (PC-AKI): 1 to 2 percent • Acute rise in serum creatine by >1.5 times baseline or > 3 mg/dl within 48-72 hour period. • Renal function measured by estimated glomerular function rate (eGFR). • At risk if poor renal function < 30 ml/min/1.73 m2 . To avoid PC-AKI (post-contrast acute kidney injury) • Check eGFR2 . • Avoid repeated dose IV iodinated contrast examinations (75 percent cleared within 4 hours). • If under 70 years and no history of renal disease, proteinuria, hypertension, hyperuricaemia, or diabetes, then don’t need to check eGFR. 1 https://www.rcr.ac.uk/sites/default/files/Intravasc_contrast_web.pdf 21 2 eGFR (estimated glomerular filtration rate) is a measure of how well kidneys are working. Unrestricted © Siemens Healthineers, 2023 Background information SIEMENS Healthineers Sequence and timing – As described in various studies Injection sequence Injection protocols for contrast-enhanced • 10 to 20 ml saline (to rule out obstruction) mammography from different studies1 • 20 ml saline • Contrast injection (see different protocols) Study Dosage Iodine Flow Scan delay Power concentration 20-30 ml saline (“clean-up” of residual contrast [mL/kg] [mL/s] [min] injector • [mg/mL] media) [25] 1.5 300 3 2 Yes [26] 1.5 300 3 2 Yes Time after injection to acquire first image [27] 1.5 300 3 2 Yes [28] 1.5 300/350 3 2.5–5 Yes • ~2 minutes [29] 1.5 350 3 2 Yes [30] 1.5 350 3 2 Yes Imaging window [31] 1.5 350 3 2 Yes [11] 1.5 350 3 2.5 Yes • Up to 10 minutes post-injection [32] 1.5 (max. 90mL) 350 3 2 Yes [33] 90mL for all 350 3 2 Yes [34] 1.5 370 3 2 Yes [35] 1.5 370 3 2 Yes [36] 2.0 400 3.5 1–1.5 Yes 22 Unrestricted © Siemens Healthineers, 2023 Background information SIEMENS Healthineers Order of examinations Studies suggest that the order of the different Example of image sequence views doesn’t significantly influence the performance of contrast-enhanced mammography. min 0 2 7 10 “The order in which the images were obtained did not seem to affect the quality of the images.”1 Pathologic Nonpathologic Pathologic Nonpathologic Additional breast breast breast breast views as needed “The order in which images are acquired is of little clinical significance.”2 MLO MLO CC CC Sequence of view: compression > low-energy image > high-energy image > release compression 1 Jochelson MS, et al. (2013): Bilateral contrast-enhanced dual-energy digital mammography [...]. 23 2 Lewis TC, et al. (2017): Contrast-enhanced Digital Mammography: A Single-Institution Experience of the First 208 Cases. Unrestricted © Siemens Healthineers, 2023 SIEMENS Healthineers calthineers TiCEM Clinical evidence for contrast- enhanced mammography Click to add footnote 24 second line Unrestricted © Siemens Healthineers, 2023 Contrast-enhanced mammography (CEM) – SIEMENS Healthineers is it something new? Historical overview 2003 2005 • First studies in the early 2000s Radiology RSNA INVESTIGATIVE RSNA | Permissions Product clearance in the 2010s RADIOLOGY All Publications • Enter w A JOURNAL OF CUNICAL AND LABORATORY RESEARCH Articles & Issues Collections For Authors Journal Info Journal Home Browse by About the Journal Authors & Reviewers Subscriptions CME Digital Mammography Using lodine-Based Contrast Media: Initial Clinical Experience With Dynamic Contrast Medium Product FDA clearance Previous October 2003 Enhancement Next Volume 229. Issue 1 Diekmann, Felix MD*; Diekmann, Susanne MD*; Jeunehomme, Fanny PhDt; Müller, Serge PhDt; Hamm, Bernd MD*; Bick, Ulrich MD* • GE (2011) Technical Developments Investigative Radiology: July 2005 - Volume 40 - Issue 7 - pp 397-404 Original Article Hologic (2013) Dual-Energy Contrast-enhanced Digital Subtraction Mammography: Feasibility Abstract Author Information • - Author List Purpose: We sought to evaluate the potential of dynamic contrast enhancement after the intravenous • Siemens (2018) John M. Lewin, MD, Pamela K. Isaacs, DO, Virginia Vance, RN, and Fred J. Larke, MS administration of an iodine-based contrast medium in full-field digital mammography. -Additional Information Material and Methods: A protocol for image acquisition was established for contrast-enhanced mammography and the mammography unit (Senographe 2000D, GE Healthcare, Buc, France) changed as From the Department of Radiology, University of Colorado Health Sciences Center, Denver; and Department of Radiology, University of required. The effect of the protocol parameters on imaging was investigated. Subsequently, 21 patients Colorado Hospital Breast Center, Rm 3140A/Mailstop F724, 1635 N Ursula St, Aurora, CO 80010. From the 2001 RSNA scientific with 25 suspicious lesions of the breast (10 benign, 1 borderline, and 14 malignant) underwent assembly. Received October 3, 2002; revision requested November 27; final revision received March 17, 2003; accepted April 7. mammography with administration of an iodine-based contrast medium (Ultravist 370, Schering AG, Berlin, Supported by a grant from the Susan G. Komen Breast Cancer Foundation. Address correspondence to J.M.L. (e-mail: Germany), after approval of ethical committee as well as permission of German federal office for Radiation john.lewin@uchsc.edu). protection, and informed consent from each patient was obtained. Three sequential digital mammographie images of the respective breast were acquired after administration of the contrast medium at a dose of 1 DOI: http:/dx.doi.org/10.1148/radiol. 2291021276 ml/kg body weight and a flow of 4 mL/s. The postcontrast images were acquired 60, 120, and 180 seconds after administration. Subsequently, the precontrast image was logarithmically subtracted from the Abstract Full Text Figures References Cited by PDF postcontrast images. Enhancement of the lesions was measured in absolute terms as well as relative to the enhancement of the glandular tissue. The subtracted images were evaluated for lesion depiction and dynamic contrast enhancement. Lesion-enhancement kinetics were compared with the histologic findings. A technique for demonstrating breast cancers, dual-energy contrast agent-enhanced digital subtraction mammography, was Results: All malignant lesions were identified on the contrast-enhanced images of digital mammography. performed in 26 subjects with mammographie or clinical findings that warranted biopsy. The technique consists of high-energy and Three of the tumors (2 malignant, 1 benign) were detected only by contrast-enhanced mammography and low-energy digital mammography after administration of iodinated contrast agent. Weighted subtraction of the logarithmic transform of not by standard mammography. Dynamic enhancement curves of benign and malignant tumors in these images is then performed to obtain an image that preferentially shows iodine. Of the 26 subjects, 13 had invasive cancers. contrast-enhanced mammography look similar to the curves known from gadolinium-enhanced magnetic Eleven of these tumors enhanced strongly, one enhanced moderately, and one enhanced weakly. The duct in one patient with ductal resonance imaging. Nevertheless differentiation between malignant and benign tumors based on the carcinoma in situ was weakly enhancing. In the other 12 patients, benign tissue enhanced diffusely in two and weakly focally in two. enhancement patterns cannot be directly taken over from magnetic resonance imaging, as suggested by These results indicate that the technique is feasible and worthy of further study. our initial results. The results are somewhat better when tumor enhancement relative to surrounding glandular tissue is used instead of absolute enhancement. @ RSNA, 2003 Conclusion: The results of this preliminary study suggest that contrast-enhanced digital mammography is a Keywords: Breast radiography, comparative studies. 00 119 ; Breast radiography, technology. 00.119 potentially useful tool for the detection and the differentiation of benign and malignant breast lesions. 25 Unrestricted © Siemens Healthineers, 2023 Clinical evidence SIEMENS Healthineers All reports in the literature have shown contrast enhancement in almost all malignant lesions of the breast... Fibroadenoma Study ID: 1aac394 …however, contrast enhancement can also be found in benign breast lesions: therefore, contrast uptake doesn’t automatically mean there’s a malignant lesion. Low-energy image Recombined image 26 Unrestricted © Siemens Healthineers, 2023 Clinical evidence SIEMENS Healthineers Review of clinical evidence1 Sensitivity Specificity Author / Year Sensitivity [95% Ci] Author / Year Specificity [95% Ci] Luczynska 2014 100% [97%, 100%] Luczynska 2014 41% [28%, 54%] Luczynska 2015 100% [96%, 100%] Luczynska 2015 32% [18%, 50%] CEM has Kariyappa 20162 81% [64%, 93%] Kariyappa 20162 83% [52%, 98%] Lalji 2016 97% [88%, 100%] Lalji 2016 70% [62%, 77%] Tardivel 2016 94% [90%, 96%] Tardivel 2016 77% [66%, 86%] • high sensitivity: 0.95 Tennant 2016 95% [87%, 98%] Tennant 2016 81% [62%, 94%] Wang 2016 96% [86%, 99%] Wang 2016 66% [46%, 82%] Fallenberg 2017 70% [64%, 75%] Fallenberg 2017 92% [89%, 95%] • moderate specificity: 0.81 Lee-Felker 2017 92% [83%, 97%] Lee-Felker 2017 90% [77%, 97%] Li 2017 100% [94%, 100%] Li 2017 50% [7%, 93%] Saraya 2017 94% [70%, 100%] Saraya 2017 91% [72%, 99%] Patel 2018 96% [80%, 100%] Patel 2018 67% [45%, 84%] Richter 2018 99% [93%, 100%] Richter 2018 85% [69%, 95%] Sorin 2018 90% [70%, 99%] Sorin 2018 76% [72%, 79%] Yousef 2018 92% [64%, 100%] Yousef 2018 71% [29%, 96%] Fanizzi 2019 100% [90%, 100%] Fanizzi 2019 83% [63%, 95%] Kim 2019 91% [59%, 100%] Kim 2019 87% [75%, 95%] Lobbes 2019 93% [87%, 97%] Lobbes 2019 79% [74%, 84%] Sung 2019 88% [62%, 98%] Sung 2019 94% [92%, 95%] Travieso-Aja 20192 93% [90%, 95%] Travieso-Aja 20192 85% [79%, 89%] Wessam 2019 100% [96%, 100%] Wessam 2019 56% [38%, 73%] Xing 2019 92% [86%, 95%] Xing 2019 90% [81%, 95%] Chi 20202 78% [71%, 83%] Chi 20202 78% [69%, 85%] Clauser 2020 93% [84%, 98%] Clauser 2020 94% [79%, 99%] Gluskin 2020 67% [41%, 87%] Gluskin 2020 96% [94%, 97%] Gonzalez-Huebra 2020 75% [67%, 83%] Gonzalez-Huebra 2020 87% [77%, 93%] Lu 2020 94% [85%, 98%] Lu 2020 88% [78%, 95%] Qin 2020 82% [65%, 93%] Qin 2020 96% [91%, 99%] Sorin 2020 100% [91%, 100%] Sorin 2020 73% [64%, 81%] Ainakulova 2021 98% [92%, 100%] Ainakulova 2021 80% [69%, 89%] Hogan 2021 100% [54%, 100%] Hogan 2021 88% [84%, 91%] Mohamed 2021 100% [77%, 100%] Mohamed 2021 64% [31%, 89%] Sudhir 2021 97% [90%, 99%] Sudhir 2021 81% [71%, 89%] Summary 95% [92%, 97%] Summary 81% [76%, 86%] 12 = 91% [88%, 93%] 12 = 93% [91%, 95%] 409% 50 % 60 % 70% 80 % 90 % 100% 12 = 0.7 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 12 = 0.7 27 1 Cozzi A, et al. (2022): Contrast-enhanced Mammography: A Systematic Review and Meta-Analysis of Diagnostic Performance. Unrestricted © Siemens Healthineers, 2023 Comparison with CE-MRI SIEMENS Healthineers Given that CEM and CE-MRI both exploit lesion vascularity, similar rules of enhancement apply for both modalities. For the recombined image, the ACR BI-RADS® – CEM lexicon published in 2022 is very similar to the one used for MRI.1 SE Reviews of scientific publications show very similar results for both CE-MRI and CEM2,3 A C However… CE-MRI seems to have slightly higher sensitivity. F • • CEM seems to have slightly higher specificity. B D G 1 https://www.acr.org/-/media/ACR/Files/RADS/BI-RADS/BIRADS_CEM_2022.pdf 2 Shahraki Z, et al. (2022): Preoperative evaluation of breast cancer. [...]. 28 3 Pötsch N, et al. (2022): Contrast-enhanced mammography versus contrast-enhanced breast MRI: A systematic review and meta-analysis. Unrestricted © Siemens Healthineers, 2023 Clinical indications SIEMENS Healthineers Clinical applications of CEM include those currently accepted for CE-MRI, because both techniques are based on contrast enhancement. CEM can be used in patients with contraindications for MRI, including those with claustrophobia or pacemakers. Potential clinical indications for CEM1 • Problem-solving after inconclusive findings on mammography, DBT, or ultrasound. • Evaluation of symptomatic patients. • Preoperative assessment of disease extent (assessing multifocality and multicentricity). • Neoadjuvant therapy response monitoring. • Post-treatment evaluation of results. • Screening in intermediate- and high-risk patients. 29 1 Sogani J, et al. (2021): Contrast-enhanced mammography: Past, present, and future. Unrestricted © Siemens Healthineers, 2023 Contraindications SIEMENS Healthineers Pregnancy Iodine contrast Severe asthma Diabetic allergy +/- metformin Renal impairment, Sickle-cell disease Uncontrolled chronic renal failure, hyperthyroidism interleukin therapy 30 Unrestricted © Siemens Healthineers, 2023 SIEMENS Healthineers calthineers TiCEM Advantages and limitations Click to add footnote 31 second line Unrestricted © Siemens Healthineers, 2023 TiCEM compared to CE-MRI SIEMENS Healthineers PROS + PROS + • Cheaper, faster, and better-tolerated • Simultaneous acquisition of both breasts TiCEM (is a mammogram) CE-MRI • Kinetic information • Better spatial resolution (shows calcifications) • Wide FOV (including axilla and chest wall) • Alternative for women with contraindications • No radiation for MRI (e.g. metal implants, claustrophobia, • Complete tomographic technique (3D) prone position) • Improved workflow: All imaging in mammo department CONS - CONS - • Sequential acquisition • Time-consuming and expensive • Kinetic information limited • Contraindications: metal implants, • Limited FOV claustrophobia, etc. • Radiation dose • Limited accessibility/availability • 2D technique • Gadolinium deposition in the brain The products/features mentioned herein are not commercially available in all 32 countries. Their future availability cannot be guaranteed. Unrestricted © Siemens Healthineers, 2023 SIEMENS Healthineers calthineers TiCEM Workflow and dose Click to add footnote 33 second line Unrestricted © Siemens Healthineers, 2023 TiCEM workflow SIEMENS Healthineers Repeat for additional views within a 10-minute window Injection of Approx. Position Acquisition of Display of iodinated 2-minute patient waiting period low- contrast agent high- low-energy and energy energy recombined image image image at the AWS 28-32 kV 49 kV Simplified workflow illustration. Workflows may vary in different countries and clinics. LE (=FFDM), HE 49kV + Titanium filter 34 The products/features mentioned herein are not commercially available in all countries. Their future availability cannot be guaranteed. Unrestricted © Siemens Healthineers, 2023 Radiation dose SIEMENS Healthineers Total TiCEM patient dose • Up to 1.5x FFDM dose, because two images are taken. Study ID: 1aaa042 • The images are taken with the grid, which means without PRIME Technology. Low-energy image High-energy image Recombined image Similar to normal FFDM 49kV with titanium filter 100% radiation dose 30-50% of FFDM dose The products/features mentioned herein are not commercially available in all 35 countries. Their future availability cannot be guaranteed. Unrestricted © Siemens Healthineers, 2023 Why a titanium filter? SIEMENS Healthineers Why does Siemens Healthineers use a titanium filter Tube yield [µGy/mAs] instead of a copper filter (like GE and Hologic)? 35,000 Answer: Titanium has a 60 percent higher tube output1 . 30,000 Advantages of the titanium filter: 25,000 • It enables to reduce the X-ray tube load. 20,000 • It enables consecutive TiCEM exams with no 15,000 interruptions due to tube overheating. 10,000 The unique titanium filter (1 mm Ti) prevents overheating, which could be a challenge for the other 5,000 vendors that are using a copper filter (0.3 mm Cu). 0 40 45 50 1 mm Ti Tube voltage [kV] 0.3 mm Cu 1 Hörnig MD, et al. (2012): Design of a contrast-enhanced dual-energy tomosynthesis system for breast cancer imaging. 36 The products/features mentioned herein are not commercially available in all countries. Their future availability cannot be guaranteed. Unrestricted © Siemens Healthineers, 2023 Why a titanium filter? SIEMENS Healthineers Competition has overheating issues, and this is stated in their user manuals! GE Hologic User manual User manual 4 Manual mode parameters The acquisition parameters have to be considered as a function of the compressed breast thickness and Caution: the breast density. Using I-View 2D Contrast increases the recovery time the machine needs before more The following tables show parameter settings for the acquisition of the Low and High energy images. In 5 most cases the breast composition should be known before the beginning of the CESM acquisition, as images are acquired. When the x-ray tube status icon appears red min a prior mammograms are usually available. If this is not the case the middle table (for 50% glandular / 50% fatty tissue) can be taken as default as the influence of the breast composition is less important for recommended wait time is shown. This wait time lets the x-ray tube temperature the CESM images compared to standard mammograms. decrease to avoid damage that can void the x-ray tube warranty. Always make sure Note: Hologic training guide For breast thickness 2 66 mm, the time between exposures should be at least 73s to avoid any that the x-ray tube status icon is green before starting an I-View 2D Contrast thermal issue (generator overheat). procedure. If the x-ray tube status icon turns red during a procedure, complete the procedure quickly using the minimum number of exposures. Note: It is necessary to observe a regular inter-exposure time (73s between exposures) and inter-patient Training guide time (5 min between patients), to avoid thermal issues with the generator and tube, and thus additional delays in the exam progress. Tube heating needs to be watched. Tube icon will flash, and give the amount of time user should wait before next exposure. 19 11:39:21 AM min 37 Unrestricted © Siemens Healthineers, 2023 SIEMENS Healthineers calthineers TiCEM Clinical TiCEM cases Click to add footnote 38 second line Unrestricted © Siemens Healthineers, 2023 Benign lesion SIEMENS Healthineers Cancer ruled out, unnecessary biopsy avoided Dense breast with density Grade C, potentially suspicious mass in both upper quadrants, BIRADS 2 Suspicion not confirmed: Study ID: 1aab988 TiCEM shows no uptake and therefore no confirmed finding. Low-energy image Recombined (Insight CEM) The products/features mentioned herein are not commercially available in all 39 countries. Their future availability cannot be guaranteed. Unrestricted © Siemens Healthineers, 2023 Malignant lesion SIEMENS Healthineers Confirmation of initial diagnosis suspected on FFDM Dense breast with irregular palpable mass, BIRADS 5 invasive ductal carcinoma Enhancement shown on TiCEM examination: Study ID: 1aab510 Invasive ductal carcinoma clearly visible due to contrast uptake. Low-energy image Recombined (Insight CEM) The products/features mentioned herein are not commercially available in all 40 countries. Their future availability cannot be guaranteed. Unrestricted © Siemens Healthineers, 2023 Malignant lesion SIEMENS Healthineers Detecting additional cancers not seen on FFDM Indication Patient with breast density Grade C was recalled after screening for lesion in the right breast. Study ID: 1aac466 Enhancement shown with TiCEM Asymmetrical mildly enhancing mass (13 mm in diameter) was seen in the contra-lateral left breast. It wasn’t seen on FFDM, but correlates with a hypoechoic nodule on ultrasound. Pathology results Biopsy results revealed an invasive ductal carcinoma Grade 2. Low-energy images Recombined images (Insight CEM) The products/features mentioned herein are not commercially available in all 41 countries. Their future availability cannot be guaranteed. Unrestricted © Siemens Healthineers, 2023 Follow-up examination after successful chemotherapy SIEMENS Healthineers Initial diagnosis concluded invasive ductal carcinoma Grade 2 in right breast, complete response after neoadjuvant chemotherapy. Study ID: 1aaa083 A clip was placed to aid identification of residual disease after therapy completion. TiCEM follow-up examination shows no contrast uptake: Low concern about residual low-volume disease after near or complete pathological response to neoadjuvant chemotherapy; clip clearly visible. Low-energy image Recombined (Insight CEM) The products/features mentioned herein are not commercially available in all 42 countries. Their future availability cannot be guaranteed. Unrestricted © Siemens Healthineers, 2023 SIEMENS Healthineers calthineers TiCEM Clinical studies with TiCEM Click to add footnote 43 second line Unrestricted © Siemens Healthineers, 2023 Initial study results on the TiCEM prototype SIEMENS Healthineers Breast Care Original Article DO: 10.1159/000478899 Published online: August 17. 2017 Study design: Feasibility study Application of BI-RADS Descriptors in Contrast-Enhanced Two radiologists read 11 cases in 2 reading sessions1 Dual-Energy Mammography: Comparison with MRI Thomas Knoglerab Peter Homolkac Mathias Hoernigd Robert Leithnerc Georg Langsa,d Martin Waitzbauera,d Katja Pinkera,b,f Sabine Leitnera,b Thomas H. Helbich a,b "Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, Vienna, Austria Division of Molecular and Gender Imaging, Medical University of Vienna, Vienna, Austria; €Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Vienna, Austria; dX-Ray Products, Healthcare, Siemens AG, Erlangen, Germany; *Computational Imaging Research Lab, Medical University of Vienna, Vienna, Austria Results Department of Radiology, Breast Imaging Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA a b beast cancer . Magnetic resonance imaging - oduction • The BI-RADS assessment was Mammography . Contrast agent anced (CE) magnetic resonance imaging (MRI) of erged as a promising imaging tool with a high Summary er detection [1, 2]. However, specificity is lim- Background: Contrast-enhanced (CE) mag increased rate of supplementary diagnostic almost identical in all cases. nance imaging (MRI) BI-RADS descriptors IRI is based on the depiction of newly formed the evaluation of contrast-enhanced dual-en. r vessels with fragmented leaky basement mem- mography (CEDEM) images of mass lesions an fred to as tumor neoangiogenesis [4-8]. Neverthe- sumed to be applicable. Patients and Methods: CE-MRI is limited to larger metropolitan areas, and One malignant case: BI-RADS 4 with suspicious mass lesions on mammography cedure is expensive and time-consuming. In addition, pa- • RADS 4 or 5) were included. CEDEM examinations were tients with metallic implants, pacemakers, allergies to gadolinium- performed using a modified prototype unit. CE-MRI was based contrast agents, or severe claustrophobic are not suitable performed using a high temporal and high spatial reso- for CE-MRI. Contrast-enhanced dual-energy mammography lution imaging protocol. 2 blinded breast radiologists (CEDEM) is an emerging new X-ray technique that is also based with TiCEM and BI-RADS 5 with evaluated all images using criteria related to contrast en- on the depiction of tumor neoangiogenesis [9]. When added to hancement intensity and morphology according to the mammography, it has the potential to increase diagnostic accuracy BI-RADS lexicon (5th edition) in 2 sessions. Histopathol- [10, 11] and can facilitate the visualization of breast lesions [11, ogy was used as the standard of reference. Results: 11 12]. Accuracy, sensitivity, specificity, lesion detection rate, and as- CE-MRI. patients with 5 benign and 6 malignant index lesions sessment of tumor size are comparable to CE-MRI of the breast were included. Enhancement characteristics were similar [13-17]. The BI-RADS lexicon provides descriptors and assess- in the malignant cases. Enhancement of the benign le- ment categories that can be used to predict the likelihood of malig- sions was moderate on CEDEM and strong on MRI. Dis- nancy for contrast-enhancing lesions on CE-MRI [18, 19]. Recent • One benign case: BI-RADS 2 with crepancies in the BI-RADS descriptors did not influence studies have used MRI imaging characteristics for the evaluation of the final BI-RADS score. Overall, the BI-RADS assess- CEDEM images [9, 10, 13, 14]; however, there is no data on the ment was almost identical in all cases. 1 malignant le- direct applicability of the MRI BI-RADS descriptors for contrast- sion was rated BI-RADS 4 with CEDEM and BI-RADS 5 enhancing lesions on CEDEM. TiCEM and BIRADS 1 with CE- with MRI, and 1 benign was rated BI-RADS 2 and BI- The purpose of this study was to evaluate the comparability of RADS 1, respectively. Conclusion: MRI BI-RADS descrip- the BI-RADS descriptors of contrast-enhancing mass lesions on C d tors of contrast-enhancing lesions can be applied for the CEDEM and MRI, and to ascertain whether this approach results LeSions CAS On CEDEM . morphologic analysis of mass lesions on CEDEM. in the same BI-RADS score. 2017 S. Karger GmbH, Freiburg MRI. Key take-away MRI BI-RADS descriptors of contrast- enhancing lesions can be applied to masses on TiCEM. 1 Knogler T, et al. (2017): Application of BI-RADS descriptors in contrast-enhanced dual-energy mammography: Comparison with MRI. 44 The products/features mentioned herein are not commercially available in all countries. Their future availability cannot be guaranteed. Unrestricted © Siemens Healthineers, 2023 Unrestricted © Siemens Healthineers, 2023 Initial study results with TiCEM using SIEMENS Healthineers MAMMOMAT Revelation Original Artide Acta Radologica The accuracy of titanium 00) 1-8 @ The Foundation Acta Radiologia Study design: Retrospective multi-center reader study1 contrast-enhanced mammography: 2020 Artide rane guidelines a retrospective multicentric study *xgepubcom/ purals-permis sions DOE 10.1 1 77/02841851 19900440 journals.sagepub.com /home/aar SISAGE 135 patients with 200 lesions (118 malignant, 82 benign) Ignacio Gonzalez-Huebra' @, Patricia Malmierca', Arlette Elizalde , Jon Etxano2, Ilse Vejborg3, Detlev Uhlenbrock and Luis Pina Three radiologists with different levels of experience Abstract Background: Recently, a new mammography system to perform contrast-enhanced mammography has become avail- Reading session in two steps: able in the market. For the high-energy acquisition, it uses a titanium filter instead of a copper one, reducing the tube load while maintaining image quality. Purpose: To retrospectively evaluate the accuracy of contrast-enhanced mammography with a titanium filter (TiCEM) in three readers with different grades of experience. 1. Low-energy (LE) image, 2. LE and recombined image Material and Methods: IRB-approved retrospective multicentric lesion by lesion study with 200 lesions, all of them initially classified as BI-RADS categories 0/3/4/5 on mar d/or ultrasound and with pathological confirmation, in 135 patients. Three readers with different level rt, resident, intermediate) blinded to the final diagnosis, retrospectively evaluated the low-ener bination of LE and recombined (subtracted) images and classified the lesions according to der I also categorized the breast density. ROC curves were performed for each reade Results: Out of the 200 lesions, 82 were ber 10 ILC, 88 IDC). The AUCs of LE versus TiCEM for were: Reader 1: 0.7 vs. 0.88, P P <0.001; and Reader 3: 0.63 vs. 0.84, P <0.001. For the three readers, the AUCs of htly superior in both dense and non-dense breasts (P <0.00 1). Comparing the AUC of LE the AUC of TiCEM for Reader 2 (resident) there were significant differences (0.7 vs. 0.83, P Results Conclusion: The accuracy of TiCEM was significant, e readers, in both dense and non-dense breasts. The accuracy of a resident reading a TiCEM study was better than the accuracy of an expert radiologist reading LE images. Keywords ur Breast, mammography, contrast-enhanced mammography Diagnostic accuracy Date received: 9 March 2019; accepted: 16 December 2019 LE image only LE + recombined image Introduction (similar to FFDM) (TiCEM) P value Mammography is the only breast imaging technique that has been shown to reduce breast cancer mortality "Department of Radiology, Clinica Universidad de Navarra, Pamplona, (1). It is usually the initial examination because it is a Navarra, Spain widely available and inexpensive technique. However, Department of Radiology, Osatek SA, Vitoria, Pais Vasco, Spain digital mammography (DM) has a variable sensitivity Breast Imaging Section, Righospitalet, Copenhagen, Denmark 4De Uhlenbrock & Partner Klinik, Dortmund, Germany in the range of 50%-85%, especially low in dense Reader 1 breasts. It is well-known that the sensitivity of DM Corresponding author: drops in dense breasts because of the overlapping Ignacio Gonzalez-Huebra, Department of Radiology, Clínica Universidad 0.70 0.88 <0.001 de Navarra, Pamplona, Navarra, Spain. tissue (2,3). This low sensitivity has induced the use Email: huebrax@gmail.com (expert) Reader 2 Key take-away (intermediate) 0.68 0.84 <0.001 The accuracy of TiCEM was significantly Reader 3 better for all the readers, with both (resident) 0.63 0.83 <0.001 dense and non-dense breasts. 1 González-Huebra I, et al. (2020): The accuracy of titanium contrast-enhanced mammography: a retrospective multicentric study. 45 The products/features mentioned herein are not commercially available in all countries. Their future availability cannot be guaranteed. Unrestricted © Siemens Healthineers, 2023 Unrestricted © Siemens Healthineers, 2023 Impact of motion correction setting on TiCEM SIEMENS Healthineers with MAMMOMAT Revelation Thieme Motion Artifact Reduction in Contrast-Enhanced Dual-Energy Mammography - A Multireader Study about the Effect of Nonrigid Study design: Reader study1 Registration as Motion Correction on Image Quality Bewegungsartefakte in der kontrastverstärkten Dual-Energy Mammografie - eine Multireader-Studie zur Wertigkeit 354 TiCEM images reconstructed with and without motion der nicht-rigiden Registrierung auf die Bildqualität Authors correction Markus Sistermanns1, Bemd Kowall2, Mathias Hornig), Karsten Beiderwellen1, Detlev Uhlenbrock1 Affiliations men mithilfe eines Bewegungskorrekturalgorithmus prozes- 1 Department of Radiology, MVZ Prof. Dr. Uhlenbrock & siert. Fünf Radiologen mit langjähriger Erfahrung in der Five radiologists evaluated images side-by-side using a Partner, Dortmund, Germany Brustkrebsdiagnostik verglichen im Side-by-side-Verfahren je 2 Center of Clinical Epidemiology, Institute for Medical ein durch den Standardalgorithmus prozessiertes CEDEM-Bild Informatics, Biometry and Epidemiology, Medical Faculty, mit dem korrelierenden, durch den Bewegungskorrektur- University Duisburg-Essen, Germany algorithmus prozessierten CEDEM-Bild. Jedes Bilderpaar Likert scale (improvement: + 1, + 2; deterioration: –1, –2). 3. Department of Diagnostic imaging, X-ray Products, X-ray anhand der folgenden 6 Kriterien verglichen: allge- Physics & Systems, Siemens Healthcare Gmbh Forch alität (1), Hautkonturschärfe (2), Bildartefaktre- Germany sionskonturschärfe (4), Lasionskontrast (5), Key words sichtbarkeit (6). Die Kriterien wurden auf el- mammography, artifacts, breast, image processi wertet (Verbesserung: +1, +2; Verschlech- received 07.09.2020 ittleren Bewertungen der Kriterien 1-5 zel- accepted 01.02.2021 nheit der mittels Bewegungskorrektur pro- published online 2021 binierten CEDEM-Bilder. Beispielsweise liegt Results sewertung der allgemeinen Bildqualität bei 0,86 Bibliography ,78-0,93). Lediglich die mittlere Bewertung von Kri- Fortschr Röntgenstr DOI 10.1055/a-1388-7712 terium 6 zeigt eine Unterlegenhelt der mittels Bewegungskor- rektur prozessierten rekombinierten CEDEM-Bilder (-0,29; ISSN 1438-9020 95%-KI -0,46 bis -0,13). 2021. Thieme. All rights reserved. Schlussfolgerung Die Anwendung einer Bewegungskorrek- Georg Thieme Verlag KG, Rüdigerstraße 14, tur in Form elner unstarren Registrierung verbessert verschie- Criteria Mean rating (95% CI) 70469 Stuttgart, Germany dene Bildqualitätskriterien der rekombinierten CEDEM-Bilder, Correspondence aber auf Kosten einer verschlechterten Lymphknotensichtbar- Markus Sistermanns keit. Abteilung für Radiologie, MVZ Prof. Dr. Uhlenbrock & Partner, Kernaussagen: Zollernstraße 40, 44379 Dortmund, Germany Die Nutzung der Bewegungskorrektur verbessert die General image quality +0.86 (0.78–0.93) Tel.: +49/2 31/96 38 60 81 90 Bildqualität. msistermanns@gmail.com Die Bewegungskorrektur könnte das Potenzial haben, die ZUSAMMENFASSUNG diagnostische Genauigkeit zu erhöhen .. Alternative Verfahren zur Bewegungsartefaktreduktion Ziel Bewegungsartefakte werden bei der contrast-enhanced sind im klinischen Alltag aktuell nicht verfügbar. dual-energy mammografieDEM) durch die technisch Contour sharpness of the skin +0.63 (0.57–0.70) bedingte Verzögerung zwischen den Low- und High-energy- ABSTRACT Aufnahmen begünstigt. In dieser Studie wurde die Wertigkeit Purpose The technically caused delay between low-energy einer Bewegungskorrektur durch unstarre Registrierung auf (LE) and high-energy (HE) acquisitions allows motion artifacts die Bildqualität der rekombinierten CEDEM-Bilder untersucht. in contrast-enhanced dual-energy mammography (CEDEM). Reduction of image artifacts +0.92 (0.84–1.00) Key take-away Contour sharpness of the lesion +0.37 (0.26–0.48) Using the motion correction setting significantly improves the image quality Contrast of the lesion +0.22 (0.11–0.32) of the recombined TiCEM images. 1 Sistermanns M, et al. (2021): Motion Artifact Reduction in Contrast-Enhanced Dual-Energy Mammography - [...]. 46 46 The products/features mentioned herein are not commercially available in all countries. Their future availability cannot be guaranteed. Unrestricted © Siemens Healthineers, 2023 Unrestricted © Siemens Healthineers, 2023 TiCEM or DBT to evaluate women recalled after SIEMENS Healthineers breast cancer screening? Original Artide Acta Radologica The accuracy of titanium 00) 1-8 @ The Foundation Acta Radiologia Study design: Prospective randomized trial1 contrast-enhanced mammography: 2020 Artide rane guidelines a retrospective multicentric study *xgepubcom/ purals-permis sions DOE 10.1 1 77/02841851 19900440 journals.sagepub.com /home/aar SISAGE 402 consecutive patients recalled after breast cancer screening Ignacio Gonzalez-Huebra' @, Patricia Malmierca', Arlette Elizalde , Jon Etxano2, Ilse Vejborg3, Detlev Uhlenbrock and Luis Pina were randomized into two groups: CEM (n=202) and DBT (n=200). Abstract Background: Recently, a new mammography system to perform contrast-enhanced mammography has become avail- All visible suspicious lesions were histopathologically verified. able in the market. For the high-energy acquisition, it uses a titanium filter instead of a copper one, reducing the tube load while maintaining image quality. Purpose: To retrospectively evaluate the accuracy of contrast-enhanced mammography with a titanium filter (TiCEM) in three readers with different grades of experience. Material and Methods: IRB-approved retrospective multicentric lesion by lesion study with 200 lesions, all of them initially classified as BI-RADS categories 0/3/4/5 on mar +/or ultrasound and with pathological confirmation, in 135 patients. Three readers with different level rt, resident, intermediate) blinded to the final diagnosis, retrospectively evaluated the low-ener bination of LE and recombined (subtracted) images and classified the lesions according to der I also categorized the breast density. ROC curves were performed for each reade Results Results: Out of the 200 lesions, 82 were ber 10 ILC, 88 IDC). The AUCs of LE versus TiCEM for were: Reader 1: 0.7 vs. 0.88, P. P <0.001; and Reader 3: 0.63 vs. 0.84. P <0.001. For the three readers, the AUCs of htly superior in both dense and non-dense breasts (P < 0.00 1). Comparing the AUC of LE the AUC of TiCEM for Reader 2 (resident) there were significant differences (0.7 vs. 0.83, P Conclusion: The accuracy of TiCEM was significant, e readers, in both dense and non-dense breasts. • The ROC curve analysis proved to be a significant advantage The accuracy of a resident reading a TiCEM study was better than the accuracy of an expert radiologist reading LE Keywords for both TiCEM and DBT over FFDM (p <0.0001). Breast, mammography, contrast-enhanced mammography Date received: 9 March 2019; accepted: 16 December 2019 • There was no significant difference between TiCEM and DBT Introduction diagnostic accuracy (p=0.23). Mammography is the only breast imaging technique that has been shown to reduce breast cancer mortality "Department of Radiology, Clinica Universidad de Navarra, Pamplona, (1). It is usually the initial examination because it is a Navarra, Spain widely available and inexpensive technique. However, Department of Radiology, Osatek SA, Vitoria, Pais Vasco, Spain digital mammography (DM) has a variable sensitivity Breast Imaging Section, Righospitalet, Copenhagen, Denmark 4De Uhlenbrock & Partner Klinik, Dortmund, Germany in the range of 50%-85%, especially low in dense breasts. It is well-known that the sensitivity of DM Corresponding author: drops in dense breasts because of the overlapping Ignacio Gonzalez-Huebra, Department of Radiology, Clínica Universidad TiCEM DBT de Navarra, Pamplona, Navarra, Spain. tissue (2,3). This low sensitivity has induced the use Email: huebrax@gmail.com Diagnostic accuracy 70% 66% Key take-away Sensitivity 97% 100% In this randomized prospective study, TiCEM and DBT show similar diagnostic Specificity 63% 60% accuracy. 1 Siminiak N, et al. (2022): Are contrast-enhanced mammography and digital breast tomosynthesis equally effective in diagnosing patients recalled from breast cancer screening? 47 The products/features mentioned herein are not commercially available in all countries. Their future availability cannot be guaranteed. Unrestricted © Siemens Healthineers, 2023 Unrestricted © Siemens Healthineers, 2023 Correlation between enhancement and cancer SIEMENS Healthineers aggressiveness on TiCEM Artide Is the Level of Contrast Enhancement on Contrast-Enhanced Mammography (CEM) Associated with the Presence and Biological Aggressiveness of Breast Cancer? Study design: cross-sectional retrospective study1 Alaa Marzogi 1,2, Pascal A. T. Baltzer 1 ,*, Panagiotis Kapetas 1, Ruxandra I. Milos 1, Maria Bernathova 1, Thomas H. Helbich 130 and Paola Clauser 1 Department of Medical Imaging, King Abdullah Medical City Specialist Hospital, Muzdalifsh Rd, Al Mashair, Makkah 24246, Saudi Arabia Department of Biomedical Imaging and Image-Guided Therapy, Division of General and Pediatric Radiology • 3 breast radiologists rated enhancement intensity from 0 (no Medical University of Vienna, 1090 Vienna, Austria Department of Biomedical Imaging and Image-Guided Therapy, Division of General and Pediatric Radiology Division of Molecular and Structural Preclinical Imaging, Medical University of Vienna, 1090 Vienna, Austria Correspondence pascal baltzer@meduniwien.sc. at enhancement) to 3 (distinct enhancement). Abstract There is limited information about whether the level of enhance ment on contrast-enhanced mammography (CEM) can be used to predict malignancy. The purpose of this study was to correlate the level of enhancement with the presence of malignancy and breast cancer (BC) aggressiveness on CEM. This IRB-approved, cross-sectional, retrospective study included consecutive patients 156 lesions (93 malignant, 63 benign) in 145 patients with examined with CEM for unclear or suspicious findings on mammography or ultrasound. Excluded • were examinations performed after biopsy or during neoadjuvant treatment for BC. Three breast radiologists who were blinded to patient data evaluated the images. The enhancement intensity was rated from 0 (no enhancement) to 3 (distinct enhancement). ROC analysis was performed. inconclusive/suspicious findings on FFDM or US were included. Sensitivity and negative likelihood ratio (LR-) were calculated after dichotomizing enhancement check for updates intensity as negative (0)" 3). A total of 156 lesions (93 malignant, 63 benign) in Citation: Marzogi, A ; Baltar, PA.Y; 145 patients (mean ay ocluded. The mean ROC curve was 0.827. Mean Kapetay P; Milos, RI; Bemathova, sensitivity was 95.49 M; Habich, TH; Claunic E la the distinct enhancem sss ve cancer presented predominantly (61.8%) with mainly observed for ductal carcinoma in situ. Level of Contrast Enhance ment of Stronger enhancen ted with cancer aggressive ness, but the absence Contrad Enhanced Mammography of enhancement sl Ispicious calcifications. (CEM) Associated with the Presence Results and Biological Aggressiveness of Keywords: breast ne s frast media; breast cancer Breast Cancer? Diagenetics 2023, 13, 754. http://doiarg/10:3390/ diagnostica130407st Academie Editar Gary J. Whitman 1. Introduction Although mammography remains the standard method for breast cancer screening, On average, readers found a 95.4% sensitivity after Received: 30 January 2023 • its sensitivity is affected by several factors, the most relevant being breast density [1]. This Rawvised: 8 February 2023 Acor pted: 14 February 2023 limitation drives the need for adjunctive breast imaging tools able to detect breast cancer Published 16 February 20123 in women with dense breasts [2,3]. Until recently, contrast-enhanced magnetic resonance imaging (MRI) was the most widespread breast imaging method, offering an accurate dichotomizing enhancement intensity as negative (0) versus visualization of breast vascularization [4]; this has changed with the development of contrast-enhanced mammography (CEM) [5]. Using dual-energy technology, CEM allows Copyright @ 2023 by the authors. the evaluation of lesion vascularization [6]. This technique requires less procedural effort Liwenice MIMPI, Buel Switzerland and is thus easier and faster to implement in the clinical workflow than MRI Breast MRI positive (1–3). This article is an open access article usually requires an additional patient visit and has a number of contraindications that do distrbaked under the ken and not apply to CEM [7,8]. Recent publications have demonstrated that the diagnostic accuracy conditions of the Carative Commons of CEM exceeds that of full-field digital mammography (FFDM), but the sensitivity and Attribution (CC BY) Barns (https:// negative predictive value are slightly inferior to those of MRI [9]. creativecommons.org/licenses/ by/ It is known from breast MRI that benign and malignant lesions can be distinguished Invasive cancer presented predominantly with distinct (61.8%) 40/1. • by their level of enhancement: due to higher vascularization, contrast medium uptake is or moderate enhancement (27.7%), while DCIS enhancement Key take-away intensity patterns were similar to those of benign lesions on Stronger enhancement was correlated TiCEM. with cancer aggressiveness, but absence • Most lesions with absent enhancement were luminal B subtype. of enhancement should not be used to downgrade suspicious calcifications. 1 Marzogi A, et al. (2023): Is the Level of Contrast Enhancement on Contrast-Enhanced Mammography (CEM) Associated with the Presence and Biological Aggressiveness of Breast Cancer? 48 The products/features mentioned herein are not commercially available in all countries. Their future availability cannot be guaranteed. Unrestricted © Siemens Healthineers, 2023 Unrestricted © Siemens Healthineers, 2023 Thank you SIEMENS Healthineers for your enthusiasm! Siemens Healthineers Siemensstr. 3 91301 Forchheim, Germany 49 Unrestricted © Siemens Healthineers, 2023