Contrast-Enhanced Spectral Mammography

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Contrast-Enhanced Spectral Mammography Illuminating Breast Cancer Detection SenoBright HD TM gehealthcare.com/senobright

Mammography is the most reliable imaging technique for breasts, but limitations can exist due to breast density. This is especially the case in dense breasts where tissues may overlap. For a final diagnosis, radiologists often need complementary imaging, such as breast MRI. However, these modalities also have limitations (access, contra-indication, waiting list, cost, etc). At GE, we have introduced SenoBright to enhance the breast care pathway and to provide an alternative diagnostic exam. We continue to lead the way, introducing the next generation of Contrast Enhanced Mammography (CESM) with SenoBright HD. Enhancing the breast care pathway 2 I SenoBright TM HD SenoBright TM HD I 3

Breast care path enhancement A simple use Accelerate your ability to make a confident diagnosis Women with dense breasts are at increased risk of breast cancer, so you cannot settle for uncertainty. You need complementary imaging solutions that deliver better visualization of breast lesions. Following an ambiguous mammogram and ultrasound, most radiologists turn to breast MRI. MRI is an excellent technology that can deliver outstanding results, however it is not always the best option due to its cost, access or contraindications. SenoBright HD is a straightforward alternative diagnostic exam that complements today s breast care pathway. Based on research and technology introduced first by GE in 2010 using contrast-enhanced spectral mammography, SenoBright HD delivers exceptionally clear images so you can give your patients a confident, accurate diagnosis faster. How does it work? Four simple steps 1 Welcome 2 Inject 3 Acquire 4 Review An intravenous iodine injection is performed on the patient in the same room as the mammogram exam. Four customary mammography views are acquired once the iodine has been injected. There is no need to change the setting or imaging equipment. The four standard mammographic views are acquired on the same mammographic system. The entire exam takes less than seven minutes and the images are available for immediate review by the radiologist. It s fast, accurate, straightforward. And it s cost-effective. 4 I SenoBright TM HD SenoBright TM HD I 5

Low Energy images How can you easily implement SenoBright HD in your clinical routine? Exceptionally clear visualization The SenoBright HD contrast agent highlights RCC LCC After inconclusive mammography and ultrasound, areas of unusual blood flow. the exam lasts less than 7 minutes. SenoBright uses multiple x-ray exposures A standard intravenous iodine injection is performed in your radiology department. to reduce background signal, effectively highlighting contrast enhanced areas. RMLO LMLO The usual 4 mammographic views are acquired on the same mammography system. Two images per view are provided. A low energy image uses standard mammographic techniques and represents tissue density. The recombined image is a contrast- enhanced image in exactly the same position. CESM Recombined images 2 MINUTES 5 MINUTES Compression Compression Compression Compression RCC LCC RMLO LMLO INJECTION Low Energy High Energy RCC LCC 6 I SenoBright TM HD RMLO LMLO

Increase your diagnostic confidence Localize known or suspicious lesions with iodine contrast Transform your patients experience HIGH SPECIFICITY High specificity: SenoBright HD provides high specificity to reduce false-positives and help prevent unnecessary exams. Reduce patient anxiety by providing a diagnosis in one appointment, one setting When a woman receives an inconclusive mammogram result, every minute waiting for definitive answers seems like an eternity. HIGH SENSITIVITY High sensitivity: SenoBright HD delivers high sensitivity for more accurate breast cancer diagnosis. By performing a SenoBright HD exam at the same time as a mammogram, in the same room, with the same equipment, you can help eliminate waiting times, lengthy exams and contraindications to breast MRI sparing your patients additional emotional, physical and financial burdens. Providing peace of mind. CLEAR & FAST Clear image quality: SenoBright HD delivers clear image quality to enhance diagnostic confidence. SenoBright HD significantly reduces acquisition time by up to 40% in large breasts, reducing motion artifacts on images, compared to the first generation of Contrast-enhanced Mammography, Two out of three patients prefer the SenoBright HD experience to a breast MRI, with faster procedure time, greater comfort, lower noise level and lower rates of anxiety 1. The new Senographe Pristina grid and enhanced algorithm also limit scattered radiation and minimize artifacts. The result: SenoBright HD delivers improved image quality and visualization of abnormalities. 8 I SenoBright TM HD SenoBright TM HD I 9

Free-up time and reduce diagnosis costs Benefit from an affordable complementary exam that reduces unnecessary exams and frees up time on your other imaging systems. SenoBright is a less expensive alternative diagnostic method. Its high specificity helps you reduce unnecessary biopsies and surgeries, while freeing up MRI time for other exams. Enhance productivity and grow your bottom line Higher clarity at optimized dose On Senographe Pristina, the Automatic Optimization of Parameters (AOP) selects the appropriate mas based on radiological density and breast thickness. SenoBright HD delivers a personalized and optimized radiation dose based on the breast glandularity. Because we are as committed to your patients wellbeing as you are. Potential reactions to contrast The risk of a severe adverse reaction to iodinated contrast medium in CESM is 0.2 0.4%, similar to that for CT contrast reaction. To address these potential reactions, the staff should undertake routine training to handle these rare but potential situations 2. Augment clinical capabilities Facilities without an MRI don t need to invest in expensive technology or refer patients outside your health system. SenoBright HD is a costeffective alternative to help you reach a confident diagnosis. Alleviate strains on budget Providers with MRI systems can reduce staffing costs and free up valuable MRI time for other procedures. Research indicates a 53% reduction in equipment costs in addition to 59% reduced staffing costs compared to breast MRI 2. 53% EQUIPMENT COSTS 59% STAFFING COSTS 10 I SenoBright TM HD SenoBright TM HD I 11

Clinical cases Invasive Ductal Carcinoma CESM Low energy images CESM images History Technique CESM Results Conclusion Patient presented for a baseline with Injection : Iodine Contrast CESM showed a large area Ultrasound biopsy was performed palpable right breast lump. Heterogeneously volume : 95 ml injected of enhancement in the lower inner and yielded multiple invasive ductal dense nodular tissue with regional at a flow rate of 3ml/sec quadrant (CESM images). carcinoma pathologies. amorphous calcifications and 4-5 discrete with pressure injector. masses. Multiples findings on ultrasound. Acquisition : 4 standard A CESM was recommended. mammographic views. 12 I SenoBright TM HD SenoBright TM HD 13

Clinical cases Extent of Disease and Neo-Adjuvant Chemotherapy Monitoring First CESM images CESM Low energy images History Patient with strong family history and very dense tissue. Presented with palpable left and breast lump, after a negative mammogram ten months prior. Left diagnostic was indeterminate. Ultrasound revealed a mass measuring 1,5 cm. The mass was solid, cystic and hypo echoic with an irregular margin mass. A bilateral CESM was performed. Technique Injection : Iodine Contrast volume : 113 ml injected at a flow rate of 3ml/sec with pressure injector. Acquisition : 4 standard mammographic views. 14 I SenoBright TM HD SenoBright TM HD 15

Clinical cases Extent of Disease and Neo-Adjuvant Chemotherapy Monitoring Second CESM post-neoadjuvent chemotherapy images First CESM Results Bilateral enhancement was noted on CESM images (First CESM images). The Ultrasound exam performed after CESM confirmed the 2 findings, corresponding to palpable and CESM abnormalities. Bilateral axilla ultrasound was also performed both were negative. Bilateral biopsies were performed and showed invasive ductal carcinoma grade 3 on palpable left side. Right incidental finding showed invasive ductal carcinoma grade 3 also. The patient was treated by chemotherapy. Second CESM Results A CESM follow-up exam was performed after 3 months post neoadjuvant chemotherapy and demonstrated an excellent response to the treatment (Second CESM images) and post biopsy clips in place (CESM Low energy images). 16 I SenoBright TM HD SenoBright TM HD 17

Clinical cases Case Solving: Negative CESM Low energy images CESM images History Technique CESM Results Conclusion Screening mammogram showed Injection : Iodine Contrast CESM showed no areas CESM confirmed a negative exam. heterogeneously dense tissue volume : 111 ml injected at of contrast enhancement This patient returned to routine screening. with new 11 mm nodule on left CC a flow rate of 3 ml/sec with (CESM images). view only. Spot compression views pressure injector. confirmed nodule and a CESM was Acquisition : 4 standard recommended. mammographic views. 18 I SenoBright TM HD SenoBright TM HD 19

SenoBright, a clinically proven technology SenoBright Installations HIGH DIAGNOSIS ACCURACY +437,000 EXAMS * +420 INSTALLATIONS WORLDWIDE +120 PUBLICATIONS ** * Estimates based on 420 sites, 5 exams/week during 4 years **Bibliography available on request 20 I SenoBright TM SenoBright TM HD I 21

GE Healthcare has been partnering with specialists in breast imaging for almost 50 years. SenoBright HD is built around the proven innovations in the GE breast care pathway all designed to give you better tools for early detection and diagnosis of breast cancer while enhancing patient wellbeing. With SenoBright HD, you gain the clarity and confidence to give your patients an accurate diagnosis faster. 22 I SenoBright HD TM SenoBright HD TM I 23

Imagination at work Product may not be available in all countries and regions. Full product technical specification is available upon request. Contact a GE Healthcare Representative for more information. Data subject to change. 2017 General Electric Company. JB52217US GEA33371 10/2017 GE, the GE Monogram, imagination at work, Seno Bright are trademarks of General Electric Company. 1 Hobbs et al., J Med Imaging Radiat Oncol. 2015 2 Patel et al., AJR Am J Roentgenol. 2017 Reproduction in any form is forbidden without prior written permission from GE. Nothing in this material should be used to diagnose or treat any disease or condition. Readers must consult a healthcare professional. gehealthcare.com/senobright