Extraordinarily powerful care

Transcription

1 Extraordinarily powerful care hologic.com breasttomo.com.au

2 Sydney Breast Clinic is a private, multidisciplinary diagnostic clinic offering one-stop comprehensive services for both women at risk of breast cancer (risk assessment) and those experiencing symptoms (diagnostic assessment). There are at least one radiologist, two companion nurses, six radiographers, two breast surgeons, two breast physicians and a cytopathologist on site every day and the clinic sees approximately 7,000 women per year, 95% of whom have mammograms. Chief radiologist, Professor Mary Rickard, was director of the first Sydney pilot mammographic screening project in 1988 and has since become an internationally recognised expert in the diagnosis of breast disease. H aving followed the clinical development of breast tomosynthesis over several years through meetings, journal publications and radiology websites, Professor Mary Rickard was keen to trial the technology at Sydney Breast Clinic, in order to see firsthand its potential clinical benefits. Having upgraded from computed radiography to digital radiography several months prior, they embraced the next advancement in the digital mammography era by installing the tomosynthesis software on the clinic s two Hologic units in January A key component of the diagnosis and screening model Tomosynthesis doesn t replace ultrasound or MRI, but it maximises the quality of our mammography service, says Professor Rickard. The clinic uses the recommended triple test approach for breast cancer diagnosis, including clinical history and breast examination, mammogram and/or ultrasound and fine needle aspiration and/or core biopsy. This approach to the investigation of a breast change or symptom has been shown to be 99.8% accurate in the diagnosis of breast cancer. Tomosynthesis is an important component of this model, as it is routinely offered to all symptomatic women for diagnostic investigation. It is also routinely offered in a screening setting, regardless of the woman s risk status or breast density. According to Professor Rickard, the additional information acquired at a screening level using this technology reduces the need for spot views at a later time. It is particularly reassuring for young high-risk women whom we see a lot of at our clinic as they can have falsely worrying breast densities and the 3D mammograms can uncover issues hidden from the 2D images. Sydney Breast Clinic uses the combo imaging mode, in which a conventional 2D image plus a tomosynthesis scan are acquired during the same compression, resulting in co-registered 2D and 3D images with both datasets available for review. Although it can take more time to interpret combo imaging, compared with 2D images only, as the radiologist must work through a series of images covering the whole breast, interpretation does get easier and less time-consuming with experience. And the advantages of combo outweigh this potential challenge, adds Professor Rickard. Our very first client who had a cancer detected by tomosynthesis was a lady in her 50s with a very strong family history of breast cancer. It was a tumour less than one centimetre in diameter which was not visible on the 2D images. She was so relieved the cancer was diagnosed at such an early stage, given the experience she has had with breast cancer in her family. Every month or so, we see a case like that. On a daily basis, we see cases in which tomosynthesis is able to eliminate uncertainty and potential concerns raised from the 2D images, continues Professor Rickard. The issue is superimposed tissue can appear as density or mass on a 2D image, but with tomosynthesis, we can scroll through the image slices and see that it is in fact normal tissue. Sometimes there is architectural disturbance in those women who have had previous breast surgery, but again we can scroll through the image slices of the scar area of concern, so that we can say with confidence that there is no cancer hiding there. Not all

3 Tomosynthesis has benefits for both sensitivity and specificity of cancer diagnosis. It is an efficient technology that improves the quality of the mammographic outcome. Its benefit is maximised by using it at both a screening and a diagnostic level. Prof. Mary Rickard, Chief Radiologist, Sydney Breast Clinic cancers recur in the scar area, but it is the most common site to be worried about, so tomosynthesis can be very reassuring for this particular subgroup of women. Professor Rickard s imaging team found the systems easy to use, timeefficient and convenient from the perspectives of the radiographer and client. Most of our clients don t realise the test is any different from the conventional 2D mammogram other than they may notice the x-ray arm sweep over the breast, the scan time is not markedly different. The positioning and compression of the breast is the same as for a conventional 2D mammogram. Radiation exposure is well within the Royal Australian and New Zealand College of Radiologists Accreditation Guidelines, says Professor Rickard. Tomosynthesis has also had a positive impact on workflow in the clinic, as it reduces the number of additional views required and to-and-fro is minimised. There is improved flow through mammography rooms and sometimes it excludes the necessity for ultrasound. Clients benefit in this regard too, as each additional view or investigation contributes to their feelings of worry and anxiety, even if we try to reassure them, adds Professor Rickard. Leading in training and education As Professor Rickard notes, tomosynthesis does require some training in interpretation but this is a simple skill to acquire for people already reading mammograms. When tomosynthesis was first introduced, all Sydney Breast Clinic radiologists participated in the Hologic workshops, in which a series of clinical cases were presented and discussed. Since then, they have had much practical experience in using the technology and have subsequently learnt to interpret the images efficiently. Likewise, their radiographers were given training in the knobology of the machines and how to use them at the workstation level. The clinic holds fortnightly multidisciplinary meetings at which they review complex or interesting cases, including those involving tomosynthesis, to ensure these experiences are shared across their knowledge pool and that teaching points are leveraged. We pride ourselves in offering a quality service at Sydney Breast Clinic and strive to make each of our tests as accurate and efficient as possible, explains Professor Rickard. Increasing awareness Sydney Breast Clinic General Manager, Linda Sebastian adds: We promote tomosynthesis as an additional quality feature for the continual improvement of our mammography service. We have reached out to GPs to ensure they are aware of our updated offering and we have also highlighted tomosynthesis information in our brochure, website and to contacts on our mailing list. The clinic hosts education sessions for referring GPs and medical specialists and also regularly conducts clinic tours and introduction sessions with their expert team, in order to build collaborative relationships. Some women specifically request to be referred here because they have heard we offer tomosynthesis. People come from all areas of town. We currently see up to 150 women per week and most of these have tomography. If our clinic numbers were to increase in the future, we expect the number of tomosynthesis scans also to increase as it is routinely recommended and very few women would refuse once they understand the benefits, said Ms Sebastian. Moving towards a future of improved cancer detection Professor Rickard says she is excitedly awaiting the final results of ongoing large international clinical trials before the tomosynthesis technology is considered for incorporation into the national screening programme in Australia. Cancer detection in a screening environment is as low as six per thousand, so we need large clinical studies to show a statistical impact of tomosynthesis in this setting. Preliminary international results of such trials do demonstrate a significant benefit, with mammography plus tomosynthesis resulting in a significantly higher cancer detection rate and enabling the detection of more invasive cancers, compared with mammography alone. The results also indicate this improvement is not restricted to high risk groups or women with dense breasts, but is uniformly distributed across all subgroups within a screening population. This is consistent with our own experience, Professor Rickard concludes.

4 Maroondah BreastScreen is responsible for the provision of mammography screening and assessment services to women living in the eastern suburbs of Melbourne. It is one of eight reading and assessment services within BreastScreen Victoria an accredited part of the national breast cancer screening program, jointly funded by state and federal governments. It provides all clinical services from the initial screening mammogram to any further procedures required to the point of diagnosis. Maroondah BreastScreen employs a multidisciplinary team of health professionals, including radiologists, radiographers, surgeons, pathologists, and nurse/counsellors, who are highly trained in the detection and assessment of the early signs of breast cancer. Images are read from multiple sites in the catchment area, including those visited by the Mobile Screening Service, and where necessary assessment is conducted for all women in their region. Annually it performs around 2,000 mammographic assessments from the screening population. The BreastScreen service forms an important part of the integrated breast service and centre of excellence in diagnosis and treatment of breast conditions located at Maroondah Hospital, Victoria. Commitment to research M aroondah BreastScreen is conducting a Government supported trial to evaluate the role of tomosynthesis in breast screen assessment and to determine whether it can replace other more traditional mammographic views and reduce the number of benign biopsies. Designated radiologist Dr Darren Lockie says: We have so far seen about six clients for whom 3D mammography has detected malignant change that was not the primary reason for assessment. A tumour was detected coincidently. This has been the case for both single focus lesions and those with multiple foci. Four of its radiologists and four of its radiographers are involved in the project. At present, the research is focussing on the diagnostic component at the assessment clinic. All women, regardless of breast density or lesion type, who require assessment for any screen-detected abnormality, are invited to participate in the trial and after As a radiologist, I find tomosynthesis helps in two ways: it is easier to perceive focal changes, and once those changes have been perceived, tomosynthesis is more helpful in characterising the changes. It increases my diagnostic certainty that there is something there and whether it is benign or malignant. Dr Darren Lockie, Designated Radiologist, Maroondah BreastScreen details are provided on informed consent, they can choose to opt in or out. For those clients who opt in to the trial, tomosynthesis is incorporated as part of their normal work-up process followed by standard focal compression views. If a client opts out, they receive standard 2D FFDM plus focal compression views. Both groups then move on to further tests, such as ultrasound or biopsy, depending on the outcome of mammographic assessment and clinical need. Dr Lockie reports that over 300 women have been recruited into the trial. Prior to the trial, we had already used tomosynthesis on approximately 100 women, so over 400 women have undergone tomosynthesis procedures at Maroondah BreastScreen to date. Approximately 90% of women who come to the clinic are opting into the trial. This is about 10 women per clinic. Depending on the outcome of the trial, it may be that tomosynthesis has a role for all women who require assessment. Dr Lockie explains all women who come to the assessment clinic receive a detailed informed consent brochure. We find many women conduct their own internet research on tomosynthesis prior to coming to the clinic, and most often, what they discover about the technology is very positive and they are happy to give informed consent to participate in the trial. Part of the research will be to conduct client questionnaires regarding their experience with tomosynthesis and comparing it with their original screening mammogram and also with focal compression views they received at assessment, Dr Lockie adds. We eagerly await the final outcomes at the end of the trial in order to evaluate client feedback. Comfort level, length of compression time, overall experience and satisfaction with the outcome are all components of the feedback questionnaire. Anecdotally, women are finding it at least the same or better than the current 2D technology.

5 Introducing the technology into clinical practice The Maroondah BreastScreen team has had experience with tomosynthesis at the associated imaging department at Maroondah Hospital since its installation in early Initially, it was used in selected women from the assessment clinic, with the tomosynthesis mammogram taking place at the hospital. In January 2012, Maroondah BreastScreen installed the 3D imaging equipment. Dr Lockie says: We went through the tendering process to select a new digital mammography machine to meet our screening, assessment and stereotactic biopsy demand, and Hologic met all requirements. The tomosynthesis package was well known from our experience with the hospital unit. And we know it has been well researched and approved through all the relevant FDA and EU processes. The design of our research project involves our radiographers using both small compression paddles and tomosynthesis for the workup for the collection of comparative data. This design has changed the radiographers workflow. However we may be able to demonstrate that using tomosynthesis for the assessment workup without needing to do coned compression views may well save time. Therefore, it s possible tomosynthesis will help us to increase the number of women we see at the assessment clinic, Dr Lockie added. There has been minimal inconvenience to Maroondah BreastScreen s clients, radiographers and radiologists. A minimal increase in interpretation time has been seen in the assessment clinic, although Dr Lockie says this will be different in a screen reading environment. From the perspective of the client, the system is well-tolerated, especially in terms of comfort. For the radiographer, the unit is user-friendly and ergonomic. And for the radiologist, the image quality is consistent and tomosynthesis increases the diagnostic accuracy and certainty compared with 2D imaging, continues Dr Lockie. Improving diagnostic confidence One area where tomosynthesis is proving most helpful is in increasing radiologist diagnostic certainty that any observed abnormalities are either benign or suspicious, Dr Lockie says. If uncertain about an area, the radiologist scrolls through the tomosynthesis reconstructions and is able to find the information needed without additional views. We are better able to categorise the appearance as benign or suspicious rather than indeterminate or equivocal, says Dr Lockie. During assessment, tomosynthesis may reduce the need for more uncomfortable focal compression views or for subsequent unnecessary procedures. Therefore, there is an increase in the number of women avoiding unnecessary benign biopsy. Dr Lockie adds: The only challenge I see is in ensuring radiologists have adequate training and experience with the technology to become confident in its application. Our radiographers underwent the applications training by Hologic and our radiologists participated in the Hologic tomo-synthesis workshops. Overall, we have received excellent support from the company. Tomosynthesis and the future of breast screening in Australia I imagine there will be a future role for tomosynthesis in both breast screening and diagnostic breast imaging, but what that exact role will be is still to be determined. From a clinical point of view, tomosynthesis has certainly demonstrated usefulness in cancer detection and characterisation and in reducing recall rates, but BreastScreen Australia, quite rightly, will not make a move until the final outcomes of larger screening trials on the use of tomosynthesis in a screening environment are known. We must watch and wait, Dr Lockie says. Once we have the final research data to demonstrate a benefit of tomosynthesis in the screening and assessment settings, the technology may possibly help us be more cost effective whilst maintaining and potentially increasing cancer detection. Collaboration between clinicians, governments and administrators is needed to determine what model will work best for Australian women and BreastScreen Australia.

6 PRP Diagnostic Imaging is a partnership of more than 50 highly trained and experienced radiologists and nuclear medicine physicians offering a comprehensive range of medical diagnostic imaging services utilising state-of-the-art technology at PRP clinics across NSW. Each PRP radiologist has direct and immediate access to this wealth of subspecialty knowledge for valuable second opinions and consultations. Dr Andrew Goy is a Partner in PRP Diagnostic Imaging and Managing Partner of PRP Gordon in Sydney, New South Wales. He was an undergraduate at Melbourne University and completed his radiology training at Royal Prince Alfred (RPA) Hospital, Sydney, and was a staff specialist at RPA. Dr Goy is actively involved in the Northern Area BreastScreen Program. An established technology Breast tomosynthesis has been in research and clinical studies for a number of years, with the first commercial breast tomosynthesis system, Selenia Dimensions, introduced in Europe by Hologic in 2008, yet it is only recently being routinely used within Australian clinical practice at certain breast imaging clinics. PRP Diagnostic Imaging is one practice that prioritises investment in cutting-edge digital equipment. It s a curious thing, Dr Goy remarks, It seems tomosynthesis is only just starting to infiltrate the breast imaging tool box, yet I heard about it way back at a Radiological Society of North America (RSNA) meeting about eight years ago. I noticed at the recent Meeting of the Breast Interest Group of the Royal Australian and New Zealand College of Radiology there was a lot of emphasis on tomosynthesis, so I am very hopeful its use in Australia will proliferate. Clear benefits for all physicians interpreting breast imaging As tomosynthesis provides 3D images of the breast, it gives radiologists a clearer view of areas that might be obscured on a 2D mammogram by dense or overlapping tissue. Essentially tomosynthesis allows us to unravel the breast, Dr Goy explains. By looking at the breast in 1mm slices, we can dissect the tissue planes that would form a composite 2D image. And we can therefore use it to find out what is making summation shadows a big challenge in breast imaging. We also have more security in our diagnoses. If we assess mammography as being normal, we feel more certain about that assessment if we have viewed tomosynthesis images. Since acquiring tomosynthesis technology, PRP radiologists are requesting fewer spot compression views instead it is possible to obtain the information by studying the tomosynthesis layers. I no longer do additional spot views. If the images appear abnormal, if tomosynthesis has unravelled an area of density or confirmed a real lesion, I will go straight to ultrasound, with the exception of calcifications, says Dr Goy. In addition, Dr Goy recognises the significant advantage of tomosynthesis for this application. It s simply a matter of specifying and viewing at the depth of the area of interest. For sites that do many localisations, I would definitely recommend tomosynthesis. It s a big plus, he says. Tomosynthesis is relevant for all physicians interpreting breast images. Our breast radiologists are respected and many work at BreastScreening programs and read thousands of cases a year and attend assessment clinics. says Dr Goy. Yet we still find tomosynthesis to be a helpful tool. For less experienced radiologists and physicians interpreting mammograms, tomosynthesis will be an even greater help.

7 Once you start to get used to what mammography looks like with tomosynthesis, it s important to start using it as the primary imaging tool. The key is not to see pathology but normality. By viewing thousands of normal breasts with tomosynthesis and recognising normality, you will immediately spot abnormality. Dr Andrew Goy, Partner, PRP Diagnostic Imaging When it comes to interpreting the tomosynthesis images, Dr Goy offers some advice for physicians new to the technology, Reading the 3D images does take some time to get used to. When first using it, it s useful to look at what you re familiar with first the 2D image and then look at the tomosynthesis images to unravel areas of density. However, once you start to get used to what mammography looks like with tomosynthesis, it s important to start using it as the primary imaging tool. The key is not to see pathology but normality. By viewing thousands of normal breasts with tomosynthesis and recognising normality, you will immediately spot abnormality. Transition to tomosynthesis: All clinical settings, all patients A year ago, when Dr Goy and his team were reviewing their options for which tomosynthesis product to install at their clinic in Gordon, it was a straightforward decision. There were two units available. The Hologic system was better, he says. Dr Goy visited Maroondah Hospital in Melbourne to observe the benefits of tomosynthesis first-hand. He also attended several Hologic workshops. Now, on the days that he works at PRP Gordon, about 12 tomosynthesis mammograms are performed daily. With PRP s commitment to patientfocused radiology, its team is always on hand to answer questions and reassure patients. Our technicians inform patients they are receiving 2D mammography plus tomosynthesis and explain the benefits of this, adds Dr Goy. The advantages of tomosynthesis are well known amongst the specialist community, but some debate still remains on how radiologists should most effectively incorporate the technology into their practices, in particular whether it is appropriate in both the screening and diagnostic environment and with which patients it should be used. According to Dr Goy, the issues of clinical setting and patient selection are clear cut. Some of our patients come from referring physicians who suspect malignancy in the breast, perhaps because of a past malignancy or a family history, or due to symptoms or indications of malignancy found upon examination of the patient. However, we also see a lot of women who elect for a variety of reasons to be screened privately and are not diagnostic cases. We use tomosynthesis plus 2D mammography on ALL patients both dense and fatty breasts, high risk and low risk. We hope tomosynthesis will improve our cancer detection rate. Our sample is too small to give us meaningful figures, but the published literature does show a significant benefit in cancer detection, and in screening programs it reduces call backs. In private situations, as at PRP, call-backs are, in effect, performed there and then and densities can be resolved quickly and efficiently with interpretation of the tomosynthesis images, explains Dr Goy. Dr Goy says he has seen several cases where the cancer was only detected with tomosynthesis and would have been missed if conventional 2D imaging was used alone. In one interesting case, the referring physician, who was a surgeon, had been very sceptical of the presence of cancer, but when we spoke to him and showed him the tomosynthesis images, he was quite impressed. The tumour was very difficult to see on the normal 2D image, but was readily seen on tomosynthesis. Every day we are able to give the all clear to women whose 2D images show little areas of density and possible architectural distortion, which can be immediately resolved with tomosynthesis, adds Dr Goy. This is one of the main strengths of the technology. Future advances Minimising radiation is vital to PRP. It is constantly researching and investing in the latest methods and technology to ensure low-dose imaging is provided to PRP patients, including the installation of radiation-reducing software to the CT scanners to protect patients and provide them with ultra low-dose imaging. Dr Goy sees this issue as a key area for research and development over the next few years. Although radiation exposure with tomosynthesis is well within the Royal Australian and New Zealand College of Radiologists accreditation guidelines, we eagerly await the next advance in tomosynthesis technology from Hologic production of a quality synthesised 2D image* from the tomosynthesis data set so that only one radiation dose is required. If this can be solved, there is no question that tomosynthesis will be the future of digital imaging in this country, said Dr Goy. *Hologic s C-View software, a lowdose 3D mammography solution, was approved by the FDA in June 2013.

8 Imaging Associates Mitcham is an independent diagnostic imaging practice owned and operated by a group of dedicated radiologists. Located at Mitcham Private Hospital, it opened in May 2012 and offers a same day reporting service and state-of-the-art innovative equipment. Dr Andrew Lawrence is Chairman of Imaging Associates and the founding Chairman of Imaging Independently. A major advance: the path of no return Dr Lawrence has just over three years experience with tomosynthesis, having first used the technology at Maroondah Hospital. I would find it incredibly difficult to go back to traditional imaging, he says. Tomosynthesis is a major advance in mammography, which is still the cornerstone of diagnosis and will remain that way for a long time. The 3D capability allows us to detect more subtle lesions specifically architectural distortions not visible on conventional 2D digital mammography. We can view breast tissue detail in a way never before possible. Instead of having to interpret the complex nature of the breast in one flat image, we can examine the tissue one layer at a time. This means intricate details are no longer concealed by the tissue above and below, but are more clearly visible. Tomosynthesis is helping the cause for earlier detection of breast cancer by its increased accuracy compared to 2D mammography and its potential to reduce callbacks for further investigation, Dr Lawrence adds. Addressing a key challenge Mammography itself is a challenging area, and according to Dr Lawrence, the main challenge for the 3D technology relates to radiation exposure. Although very low X-ray energy is used, a tomosynthesis mammogram is usually performed together with a traditional mammogram, meaning patients receive slightly more radiation. This to some extent will be off set by the fact that tomosynthesis often precludes the need for additional spot views. Imaging Associates Mitcham has piloted an early version of Hologic s C-View imaging software, which generates 2D images from data acquired during a breast tomosynthesis exam and eliminates the need for an additional 2D exposure as part of the 3D exam. Although the software-generated 2D images weren t as appealing as normal 2D images, they were more than adequate for use within the clinic. I have seen images from the more recent C-View software and it looks much more promising. This is also great news for patients as it means less time under compression, resulting in greater comfort and a lower radiation dose, says Dr Lawrence. Effective implementation into clinical practice At Imaging Associates Mitcham, around 6-10 women undergo 3D mammograms each day and the numbers are growing. We take the attitude that all of our patients should have tomosynthesis, says Dr Lawrence. I believe this has significantly improved our rates of cancer detection. We have had many cases in which the tomosynthesis technology detected something that wasn t visible with the 2D technology probably up to 50 cases. It s astounding.

9 The development of the competitor product is not nearly as sophisticated as the Hologic tomosynthesis system, so when it came to deciding which unit to choose, it was a no brainer. Dr Andrew Lawrence, Radiologist, Imaging Associates Mitcham, Victoria We have also had many patients who were given the all-clear from their 2D screening mammogram, but went on to develop symptoms and were subsequently diagnosed with cancer just a few months later. The timeframe is such that it s hard to believe the tumour developed since screening, adds Dr Lawrence. Imaging Associates Mitcham also uses tomosynthesis in combination with other diagnostic tests. We still do a lot of ultrasounds, says Dr Lawrence. There are cases in which we won t detect something on tomosynthesis that we do on ultrasound they are complementary tests. Dr Lawrence says they have recently expanded their innovative technology offering by adding Hologic s new Affirm Tomosynthesis Breast Biopsy Guidance System to their facility. Positive feedback from patients, radiologists and referring physicians Dr Lawrence reports very positive feedback from women who have undergone breast tomosynthesis exams at the clinic. When we explain tomosynthesis to patients, we tell them the machine is similar to a conventional mammogram, but instead of a static tube, the x-ray arm moves in an arc taking a series of images at various angles, and that the scan takes just a few seconds. Patients are usually very interested in new technological advancements and we have had no problems with anyone not wanting to have a 3D mammogram. As for our radiologists, we often comment that when we scroll through tomosynthesis images, it is like the clouds have parted and all is now clear. It really is a revelation moment. We don t have to make as many uncertain judgments after viewing the images and we can be more definite when calling something benign or suspicious. For this reason, tomosynthesis has significantly reduced the number of category 3 results, indicating an abnormality in the breast that is probably benign, but which we believe needs to be monitored, continued Dr Lawrence. Workflow at Imaging Associates Mitcham is similar with tomosynthesis as it was when only conventional mammography was used. It takes more time to read the images as there are more data to process mentally, but not an unreasonable amount of time and, with practice and experience, it s possible to become quicker and more efficient at interpretation, Dr Lawrence says. The new facility and state-of-the-art technology, including tomosynthesis, has helped Imaging Associates Mitcham fulfil the high standards its radiologists set themselves. Dr Lawrence says their referring clinicians are confident in the service their patients are receiving. In particular, referring surgeons are very excited about the technology and are incredibly loyal to our service. They are happy to recommend tomosynthesis to any of their patients. Continued learning and collaborative education: A high priority The team at Imaging Associates Mitcham underwent training on the use of tomosynthesis and also works with outside clinicians to drive educational opportunities. Dr Lawrence participated in the FDA training program on tomosynthesis a few years ago. It was an 8-hour session with radiologists from Massachusetts General Hospital, during which we discussed around 150 cases, says Dr Lawrence. The radiologists at Imaging Associates Mitcham also regularly showcase and review interesting cases internally to aid continued learning. In addition, the clinic conducts educational initiatives to promote the use of tomosynthesis. We visit local GP practices and present cases in which tomosynthesis made a real difference. We also assist with group learning sessions or CME-focused activities and run meetings with other breast radiologists and exchange ideas, adds Dr Lawrence.

10 Maroondah Hospital is a community hospital in the outskirts of Melbourne offering a comprehensive imaging service. Medicare bulk-billing means patients are not charged for their imaging procedure. Staff includes radiologists, radiographers, sonographers and specialist nursing care. It is also a recognised training centre for radiographers. Maroondah Hospital was Melbourne s first hospital and Australia s second to offer tomosynthesis technology. A success story Having used tomosynthesis on an estimated 6,000 patients (about a day) since it was installed in December 2010, the team at Maroondah Hospital is hailing the technology as a real success for the facility. Dr Vivek Ramachandran, Director of Medical Imaging at Maroondah Hospital says, The most significant benefit is that we are detecting more cancers than we did in the past. We have seen a 30% increase in the cancer detection rate in our group. Dense breasts were always difficult to image using 2D mammography as cancers can be easily concealed, even at 100x magnification, says Dr Ramachandran. It s worrying when things get missed. Sometimes we would see a patient with a lesion that was probably there when she had a 2D mammogram two years earlier, but it was just not visible at the time. Detecting these additional cancers is not only great for the patient and the community, but it s also good news for the hospital as it builds on the excellent reputation of our multidisciplinary team of experts. Another advantage of the technology is that it is time-saving it almost eliminates the need for localised spot views to reach a diagnosis because we can use the tomosynthesis slices to clarify, Dr Ramachandran added. The image quality is incredible. We are clearly seeing more than we could before many cancers apparent on tomosynthesis slices are not seen on 2D views, said Stephanie Paul, Designated Radiographer for Mammography and Supervisor of the Breast Imaging Department. Tomosynthesis enables us to scroll through individual slices of the breast where there is tissue summation. We can then look thoroughly through the area. Every single day, it helps us immensely. The whole process is much more streamlined, from examination through to diagnosis. Plus, the Hologic 3D platform is very user friendly, so that s another big tick from a technologist s point of view, says Stephanie. All patients seen for breast diagnosis at Maroondah Hospital receive tomosynthesis imaging as well as 2D mammography. Tomosynthesis has incorporated into our diagnostic practice extremely well and complements our other imaging modalities, such as ultrasound, added Stephanie. A major advance in breast imaging According to Dr Ramachandran, tomosynthesis is a huge step forward in breast imaging: It s different to all other advances made in mammography in the last two decades. Previous developments focused on improving the image quality to try and pick up greater detail. Ultrasound and MRI had their own role, but we could never be 100% sure when giving the all clear. MRI is also of course costly and not easily available. There was a huge vacuum in imaging modalities and tomosynthesis has now filled that need. There is nothing else on the market that can achieve what tomosynthesis can achieve, adds Dr Ramachandran. Glynn Ward, Associate Director of Operations, Medical Imaging says, When we were evaluating tomosynthesis products, Hologic s technology seemed particularly leading edge. Hologic has a serious focus on women s health, which appealed as it very much fits with our values. Our decision was reinforced from what we saw at the Hologic training workshops in 2010.

11 Tomosynthesis has been a real success at Maroondah Hospital we feel the inclusion of tomosynthesis provides the most complete and comprehensive diagnostic workup. Glynn Ward, Associate Director of Operations, Medical Imaging, Maroondah Hospital Ongoing advances and refinements Dr Ramachandran says any challenges or unmet needs that have been identified since the roll out of tomosynthesis are being addressed. It s positive to see Hologic listening to the needs of the medical community all products on the market should be regularly reviewed and refined in response to user feedback, and this is what Hologic is doing. For example, there was some concern over the slightly higher radiation dose as a result of combo imaging, but this has been overcome through the development of C-view software. In my view, the greatest challenge lies in biopsying those lesions that are only picked up on tomosynthesis. In these cases, biopsy is not possible and the patient has to undergo surgery resulting in greater discomfort and anxiety, says Dr Ramachandran. Hologic has now addressed this emergent need identified by its tomosynthesis users and has developed tomosynthesis biopsy technology to help radiologists locate and accurately target regions of interest only visible - or better visualised - in tomosynthesis images. The tomosynthesis biopsy option also has the advantages of faster lesion targeting, reduced patient procedure time and radiation exposure. 1 It would be an even greater advantage if Hologic was to add a prone table tomosynthesis biopsy technology to their future pipeline, as this is the optimal position for biopsy, Dr Ramchandran adds. Spreading the word The team at Maroondah Hospital initially had to educate referring clinicians about tomosynthesis. It was such a unique concept, Dr Ramachadran explains. However, once they saw a couple of cases and the benefits it can offer, there was no turning back. Now they re the ones pushing for it. We also receive tomosynthesis referrals from hospitals, private practices, and from radiologists who are not able to diagnose with certainty using 2D mammography. Our workload has therefore increased and waiting times have risen slightly, however now more breast imaging centres around the country are installing tomosynthesis, the number of these referrals is levelling off again, says Dr Ramachadran. Stephanie adds that tomosynthesis is becoming more well known amongst patients who are empowering themselves primarily through Google with information on advanced technologies available to them. The team at Maroondah Hospital highly recommends any clinics considering up scaling their equipment to visit a clinic using tomosynthesis. If you look at some cases and compare 3D with 2D images, you can clearly see how tomosynthesis can be used and the benefits it offers you and your patients. Don t worry if it initially seems more time consuming or complicated; it actually makes things much easier, says Dr Ramachandran. Many people come to see our tomosynthesis system and we have a number of cases we like to showcase, Stephanie adds. In addition Hologic s in-depth applications training, held over 4 days at the hospital, taught us how to use the machines to a very high standard. Defining criteria for tomosynthesis in a screening setting The imaging service at Maroondah Hospital is a diagnostic practice only, and mammography screening and assessment services are undertaken next door at Maroondah BreastScreen. Dr Ramachandran says tomosynthesis should definitely have a role within the screening setting. It comes down to the time the radiologist spends on each mammogram the reading of tomosynthesis images would require an extra few minutes on each case, which is significant. If there are set criteria established to identify which patients may require 3D versus 2D only, we can overcome this hurdle. And for those patients that would benefit from tomosynthesis in a screening setting, the advantages could be life-saving, added Dr Ramachandran. 1. Data on file with Hologic, Inc.

12 Mater Imaging is a private comprehensive diagnostic imaging practice located in the Mater Hospital, North Sydney. Mater Imaging has a large out-patient referral base and performs over 5,200 mammograms annually. These are primarily diagnostic and surveillance mammograms in symptomatic and high-risk patients. Four Breast Radiologists perform mammograms, ultrasound, fine needle aspiration biopsy, as well as core, stereo and MRI biopsies, surgical localisations and MRI procedures. The radiologists form part of the Mater Breast Multi-Disciplinary team, who meet weekly to discuss diagnoses and tailor treatment plans to individual patients. Multiple benefits for the multidisciplinary team Breast Radiologist Dr Merran McKessar says that she and her multidisciplinary team are converts to tomosynthesis technology. They are highly experienced in its use, having performed over 5,200 3D mammograms in the past 12 months alone. Recent media attention on the use of breast tomosynthesis has seen our waiting list grow, explains Dr McKessar. More women are seeking the added reassurance that 3D mammography provides and returning to the Mater for their breast imaging. The team at Mater Imaging heard about tomosynthesis as an R&D concept when they were reviewing their digital mammography technology as early as Tomosynthesis was emerging as a very exciting choice, says Dr McKessar. As a tertiary referral diagnostic breast imaging centre, we saw the benefits of incorporating tomosynthesis into our protocol, including its potential to increase cancer detection, decrease the number of workup images required, reduce recalls for extra views and provide more information to the multidisciplinary team for targeted diagnosis and treatment. We saw the advantage of this for improving mammographic workflow in a busy department and this has indeed played out in our clinical experience over the past 12 months. Overall, the technology has been extremely beneficial and we have certainly detected cancers on tomosynthesis that are not visible, or only visible in retrospect, on 2D mammograms. Tomosynthesis enables us to better differentiate tissue overlap versus a real lesion on the mammogram, as well as better define the margin characteristics of true lesions. This has reduced our need for extra mammographic views significantly. We are also able to better localise the depth and true position of lesions within the breast, especially for smaller and subtle lesions. This enables better targeting of ultrasound to the suspicious area and enhanced ability to then proceed to biopsy under ultrasound or stereotactic guidance. We see a large number of patients requiring post-operative assessment and treatment, and tomosynthesis is very useful in the evaluation of the tissue distortion surrounding surgical scars. For calcifications, even though the 3D images do not enhance morphological analysis, the enhanced assessment of distribution has been extremely helpful in evaluating significance and need for further investigation. Our increased confidence in assessing mammograms as normal, or warranting further investigation, has been invaluable. It is particularly reassuring when ultrasound is not performed.

13 As a tertiary referral diagnostic breast imaging centre, we saw the benefits of incorporating tomosynthesis into our protocol...we saw the advantage for improving mammographic workflow in a busy department and this has indeed played out in our clinical experience over the past 12 months. Dr Merran McKessar, Breast Radiologist, Mater Imaging On the technical side, our mammographers like the digital technology workflow, intuitive operator interface with in-room monitor to review the image and the speed of acquisition and reconstruction. These features have led to an increased interest in training in mammography in our department and increased our patient throughput. Our multi-disciplinary team of surgeons and treating clinicians have also become convinced of the benefits of improved cancer detection by tomosynthesis we now receive referrals from our clinicians specifically for tomographic imaging when previous conventional imaging has been unhelpful or ambiguous, Dr McKessar says. Advantages far outweigh any challenges When asked if they had experienced any challenges with tomosynthesis technology, Dr McKessar noted that there is a learning curve in reviewing the 3D images on the workstation, which increases the reporting time initially, but explained that this does reduce somewhat with experience. The disadvantage of increased time to review images is outweighed by the benefits of increased cancer detection, and increased confidence of assessment, she added. We did have a few integration issues with PACS, so it is important to tie in with the PACS vendor upfront to ensure their product supports the 2D and 3D mammographic digital formats. There is also a question of the increased radiation exposure from the tomosynthesis sweep. Dr McKessar says: We put this into perspective in our diagnostic setting, as the potential benefit outweighs the negligible risk. We are pleased this has now been addressed with Hologic s C-View synthesised image software and look forward to incorporating this in the near future. From the patient perspective, our surveys on patients who have annual mammograms here and have experienced CR mammography technology in the past demonstrate that the additional compression time and positioning technique required for the tomo sweep is well-tolerated and not an issue. Our mammographers explain the benefits of 3D technology so that patients anxiety is reduced. Tomosynthesis complements range of leading edge breast-imaging modalities The Hologic 3D mammography unit at Mater Imaging was installed in November 2011 and the combo 2D and 3D tomosynthesis mode was incorporated into routine clinical practice for the breast diagnostic work up of all women seen at the clinic. All Mater Imaging radiologists attended the Hologic tomosynthesis workshop and had applications specialist support on site for one week to train the trainer. According to Dr McKessar, the installation process went smoothly: It was installed in two stages as the Affirm biopsy guidance system was not immediately available; however this delay enabled us to become familiar with the unit before attempting biopsies a few months later. At the time we were investigating our options for digital mammography, Hologic had the best technology available with integrated 2D and 3D combo mode and stereo with a roadmap to the C-View synthesised image software, says Dr McKessar. This was well aligned to Mater Imaging's philosophy and reputation for investing in leading-edge technology across all modalities and complemented our other advanced breast imaging offerings, including high-resolution breast ultrasound, breast MRI and multi -modality biopsy procedures. Due to its benefits, tomosynthesis has rapidly become an integral and essential part of multidisciplinary breast assessment at Mater Imaging, added Dr McKessar.

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