So, I'm going to be discussing the BI-RADS mammography lexicon update. Okay, so I wanted to let you know that Dr. Mimi Newell is our fearless leader, and she's the BI-RADS committee chair. And she's put our group together, along with myself, Jessica, who's doing ultrasound, Wendy, who's doing MRI, and Peter Eby that's doing audit. So all the comments in the slides that you're going to see in this presentation are the property of the ACR. And all the proposed changes are all in preliminary status, so I do caution you into reviewing this material with us, but we're still in the process of significant changes and editing that could occur, so I don't want you to take everything that we say as the final word. So the update overview, we've had a lot of preliminary comments that were made initially, and each subcommittee has had significant and specific updates that were in the process of editing, and we expect that we'll release this product the end of 2023. So the update overview, every section, the mammography, the ultrasound, the MRI, every section has been reviewed. We've looked at the current evidence, expert consensus, expert opinion, and the review process initially was each subcommittee, like the mammography subcommittee, had a group that got together and worked on it. That took about a year. And then now the subchairs have been getting together on a regular basis and reviewing the content from each section. And then it's going to go to the full committee, and after that, an additional group of experts will be convened to review this. So it has still a process to go through. And our goal has been to optimize, really, the ease of search if you're looking for something within the atlas, so you don't have to read an entire section to get to it. And so we try to make any search patterns easier, and also reviewing the atlas for clarity and updating it, and highlighting any new content throughout. We've transitioned towards structured clinical indications that are modality neutral, so I think this is very significant. So basically, when you're looking, whether it's the mammal section or the MRI section or the ultrasound section, you will find similar modality neutral indications, such as if you are screening asymptomatic, that will be a major indication in the category, the diagnostic category or workup, diagnostic current breast cancer, and then we'll have the optional subcategories, and the indications will be elevated risk, and then you may want to give the relevant history, if there's a gene mutation or what the estimated cancer risk may be, if the patient has dense breasts, and that may be the optional subcategory under screening, completed treatment for breast cancer, and so forth. The diagnostic workup will also have clinical findings as a subcategory, the imaging findings, if it's a follow-up by RETS-3, if it's a follow-up after a benign biopsy, if it's an implant assessment. And then on the diagnostic end, such as current breast cancer, it may be extent of disease prior to initiation of therapy, it may be response during or after neoadjuvant chemotherapy, and then additional information and relevant history can be added, such as location and size of the cancer on the prior imaging, and so you see, we want to make not only modality neutral, but the indications, and that we're transitioning towards making this much more comprehensive and easier to identify things within the way we report. So given the fact that these indications will be modality neutral, that will make it easy for RISC vendors and PACS vendors to really create templates that, for structured reporting, that will make it easier for us radiologists, and also for anyone that's doing clinical research, to be able to pull different things out of our reporting. And the billing and coding, our reimbursement, that will become more transparent and easier for our staff. Now the method of detection declaration is also being added for breast cancer, so that will help us with significant data collections and research and recommendations and guidelines for our subspecialty. This has been a tremendous amount of work by the Screening and Emerging Technologies Committee of the American College of Radiology Breast Commission for the method of detection, and that all goes to Peter Eby and his group, and to be included in regional and national cancer registries. So if you're looking at how we're going to do this reporting, let's say, an example may be that it's a diagnostic examination, and then there's a finding, and the finding may be nipple discharge, and the diagnostic examination may be the mammogram. So as I said before, this really should help us pull out of our reporting important findings and help us with our local medical outcomes within our practice, also national benchmarks. If we have a diagnostic patient that's a current breast cancer, we may want to find out response to treatment, so the final reporting will have appropriate assessment category, which may be a B4 if there's a new finding, or a B6, known cancer. If it's a BI-RADS 3, then we'll give it, either it'll make it a BI-RADS 2 by the time we're done, or maybe this is suspicious and not a 3, and move it to 4. That'll make it easy to pull this out of our reports. So you can see the examples I have there. So much more detail-oriented, more accurate data collection. We want to be accurate in what we're retrieving from our reporting and making it easier for ourselves to be able to identify things. So the vendors may have tools to support this type of searches and, or language that will make it easier. So for my mammography subcommittee, I'm the chair, and I've had the pleasure to work for the last two years with Sally Friedwald, Lars Grimm, Steve Poplak, and Janice Sung. We worked very closely together the first year, and then when we went to the sub-chairs, we've had sometimes monthly meetings to review things that are happening at the sub-chair level. So the lexicon for the mammography section has been updated and expanded with examples that are predominantly digital mammography, but also including digital breast tomosynthesis throughout and synthetic mammography images. So that has been a significant change in updating all the images throughout the mammography part of the atlas. The screen film images have been removed, and the captions, as previously, uppercase is the most dominant finding, what we're trying to showcase, but there are also other descriptors, so those additional descriptors will be there in lowercase letters. So we may be describing the shape of the mass, and that's the dominant finding, but also discussing margin and density, and those will be also there. We try to include pathology as often as we could have the pathology available, and then also the management, we realize, is based on the most suspicious feature. The guidance chapter actually was introduced in the fourth edition, and that was in response to a lot of questions from the members about terminology, auditing, management. So now the guidance chapter actually is there to help with the management of different scenarios that may not be typical or a bit off the beaten path, and so we want to answer questions that members have in the clinical setting to improve consistency amongst breast imaging practices. So this chapter has been updated completely to incorporate FAQs, and particularly include digital breast tomosynthesis adoption. So what we've done with digital breast tomosynthesis is that we've defined what screening and diagnostic examinations are, and we've included tomo in this, and also the benefit of tomosynthesis for lower recall rate and higher cancer detection. We've added text that tomosynthesis allows better visualization of a lesion's margins, and improves us in localizing a lesion within the breast. And even when that lesion is seen only on one view. So this is very significant, and that's a change within the lexicon. So including that, there may be conspicuity of a lesion and localization on tomosynthesis that may eliminate the need for doing additional mammographic views all the time. We still may do it on occasion, but we don't have to do it every time. For breast density in the fifth edition in 2013, we transitioned from percentage of dense tissue that we see on the image to an assessment that the overlying tissue may obscure and hide a cancer. So this classification moves on in the sixth edition and continues. So if you see that there's any region on the mammogram, on the image you're looking at, that it's dense, so potentially we may not be able to see a breast cancer, then the assessment of that densest region is how you're going to interpret the mammogram. So the categories, we all know them, for breast density have been simplified a little bit from the prior descriptors, just to make it a little easier for us. So A is almost entirely fatty, B, scattered tissue, C, heterogeneity dense, and D, extremely dense. Now if you have the breasts that may fall into different breast density categories, the right is different than the left. The greater density of the two is assigned for the mammogram. And we want to assign breast density clearly on every examination when the patient comes in, because we know weight changes, fluctuation, hormonal changes may, you know, so we want to assign the breast density, and obviously we want to be consistent. We also added significant language in how breast density is important, because the mammographic accuracy and also breast cancer risk. So the impact predominantly is because of the masking effect, because we may indense fibroglandular tissue, we may hide something that we need to find, and perhaps that may be more significant than the inherent risk. But similar to us getting older, a mutation genetically, family history of breast cancer, and also a reproductive history, having dense breasts, we know there's some inherent risk there for developing breast cancer. We've added language to discuss how do you compare the different breast densities, and what is that ratio for risk. And so it's compared to women with scattered fibroglandular tissue, which is, you know, most of the population that we end up viewing. And we added odds ratios, comparison with fatty, for heterogeneity dense, and also for extremely dense. Now onto calcifications. So typically the benign calcifications, we've had the term popcorn-like, and we removed that term, and we replaced it by coarse. So coarse calcifications, we all know, we think about an involuting fibroadenoma, so, you know, when we think of this, they may call it less, they may become a single very large calcification. So an involuting fibroadenoma may be associated with the mass or the calcification. So now popcorn-like is removed, and now we have coarse. So there may be some overlap in this case, when we look at the typically benign descriptor that's coarse, with the suspicious descriptor that's coarse heterogeneous. So typically we'll see the coarse calcifications are larger, and that may help us define it clearer. Punctate calcifications, which have been a subset of round calcifications, when they're less than 0.5 millimeters in size, has been removed, given how impractical it is to measure that less than 0.5 millimeters to call them that. So now they're under the round calcification descriptor. Layering is our new term for the previously called milk of calcium. And so layering calcifications can be crescent-shaped, semi-lunar, corvillinear, and we may see them obviously on a 90-degree lateral, medial-lateral view, the best, or on the medial-lateral oblique view. And on the cranial-caudal view, they may look smudgy, and more difficult, round, and more difficult to identify. As for a solitary dilated duct, in the fifth edition it was endorsed that tissue diagnosis is recommended if a solitary dilated duct is seen, unless there's a benign etiology that's demonstrated. So we reviewed the literature. It does confirm that having a solitary dilated duct on a mammogram is pretty rare. And when it's not associated with any suspicious imaging features, such as a mass, architectural distortion, or associated calcifications, it is benign. So in patients that have no symptoms, asymptomatic individuals is a low likelihood of malignancy when you have a solitary dilated duct, and that can be considered benign. However, if you have symptoms, if the patient is symptomatic, or if there's imaging features that look suspect, then obviously we have to do additional imaging, and then we need a tissue diagnosis. And that's it for my update. My name is Jessica Leung. I'm a breast radiologist from MD Anderson Cancer Center in Houston. And like the rest of the committee members, I have the honor and privilege of working within BI-RADS for this edition. I am the subcommittee chair for ultrasound, and this is going to be my topic. So I want to start out with this, which is a slide that it takes a village. We already talked about the organization, how there's an overall committee, the subcommittees. Some of us may recognize this phrase as Hillary Clinton's book in the 1990s. It's interesting, it's actually from a North African proverb I learned about how coming together to take care of families and children. So on that note, the recognition to the subcommittee members of ultrasound, and just going around in a counterclockwise alphabetically, Dr. Baker, Hooley, Dr. Loving, and Dr. Rappellier, it's been really fun and an excellent journey that is continuing. So work in progress. I know that this is something that we want to know what's going to be in it. As Tula already said, that this is going to be very much continuing to evolve with likely or possibly, probably significant changes to come. So just to say these are work in progress that's not quite ready to be discussed, but we are thinking about an ultrasound subcommittee, some of these ideas. Tissue composition, okay. Currently within BI-RADS, we have tissue pattern as a discussion under tissue composition, but thinking of introducing the additional element of fibroglandular content. Some of you may know that as glandular tissue composition, there has been literature about in terms of a descriptor, how it affects ultrasound findings, and perhaps even risk, how much of a risk factors can be determined through that component of ultrasound. Discussion on emerging technologies, and you know there are quite a few on the ultrasound front, some of which are FDA approved. How much, you know, if or how much or how that should be discussed, that is a work in progress. And then finally, we are thinking of a kind of special language, if you will, that speaks to the layperson, particularly as, at least in the United States, that patients are given increasing access, and even encouraged, if you will, to directly review their reports, which may include the images, as well as what we say in terms of our dictations. Okay, so this is another famous cover, which is for the New Yorker in 1976. It shows, of course, those of you Manhattanites in here, not just New York City, but actually Manhattan, and Chicago, we're right here, okay. My new hometown or new home state of Texas, maybe not so new, is down here, okay. And of course, the rest of the world being out there. So this is just a minute to show you the location, location, location. And someone who grew up in San Francisco like me, you know, it's always about location, right? And I bring this up to talk about how we are giving recognition to the fact that the environment matters, the milieu, if you will, of our cancer genesis, the stromal elements. And on that note, we are proposing to introduce a new element in the associated features section of the ultrasound subsection. We're thinking of calling it an echogenic rind, and this will be defined as a thick band of echogenic tissue surrounding all or part of a breast mass. It will disrupt the texture of a normal tissue around the mass, and likely represents the desmoplastic reaction or peritumoral edema that some cancers can exert on its environment, the milieu. Now this is distinct and opposite, actually, from what's called the echogenic pseudocapsule. So just to stress, this is the echogenic pseudocapsule, and this is a fibroadenoma. And an echogenic pseudocapsule, in contrast to the echogenic rind, is usually uniformly thin, and usually the shape that is associated with this associated feature would be oval, so suggestive of a benign process, such as a fibroadenoma. In contrast, the echogenic rind is less sharply demarcated, thicker, more variable in thickness, and that can be associated with a mass of any shape, not just oval. So here's one nice demonstration of an echogenic rind. The two arrows point to the rind part, if you will, that's brighter, and of course we recognize the shape as being irregular with antiparallel orientation, and this pathology was an invasive ductal carcinoma. Now, one important question is, how are you gonna measure it, in terms of reporting sizes to our clinicians? And we decided that the echogenic part will be included in the mass, because studies have shown that that correlates best with the pathology size and histology of what's tumor. And the current literature shows that this finding, this associated feature, has a high positive predictive value for cancer. And if you see this, you should biopsy it, unless the lesion is proven to be benign in some fashion. Because you've had a previous biopsy, perhaps been stable for many, many years, but a notable exception of the echogenic rind being associated with a definitively benign histology would be fat necrosis. Now, of course, as we know, fat necrosis is a big mimicker, and often we'll still need to biopsy it. But here's one nice case of a mass with an echogenic rind that we do not need to biopsy, because it has a nice correlation and mammography for this palpable lump being here on the right side of a leucine center. That's fat density, and that, of course, is classic mammographically for fat necrosis. Okay, so the next kind of change of view, what we're thinking about coming down the row, is kind of what something looks like to you, something that hits you like a thing, something with infinite three-dimensionality, and something that's more blobby, if you will. So what's shown on the left, these shapes are meant to be suggestive of something really more of a thing that stands out. And this is meant to show you the blue and the green figures here, something more blobby. And just to make a disclaimer, blob will not be a Bi-Rad's term. It's pretty much agreed upon. So given the current advances in ultrasound equipment capabilities and knowledge of breast ultrasound, there is increasing awareness and identification of abnormalities at ultrasound that do not rise to the criteria of a mass. And we're proposing to call that non-mass, non-mass something, okay, that has to be TBD to be determined, maybe non-mass lesion, non-mass finding, those are the potential candidates. So this will be a new category of sonographic finding, like a mass is a sonographic category. This will lock the three-dimensionality, the oomph, you know, the presence of a mass. And it will be identifiable in at least two planes, but maybe primarily visualized in one plane only, kind of like your non-mass enhancement at MR, kind of like your asymmetry at mammography. It will lock a definable shape and margin for assessment, and if malignant, histology is more likely to be in situ versus invasive cancer. Ethogenicity, these are terms being proposed to describe them, hypoechoic, isoechoic, hyperechoic, and mixed. Distribution, this will be an important component, like non-mass enhancement at MRI. And the terms being proposed are regional, focal, linear, and segmental. Like MRI, non-mass enhancement, linear, and segmental will carry with it a higher probability of malignancy. Now, importantly, unlike a mass, shape and margin will not be applicable, because kind of by definition, the non-mass shape margin not so characterizable, and likely will include also orientation, and that will be parallel, anti-parallel. Imaging variables that are associated will be significant in terms of characterizing such a category of lesion. And the ones that are suggestive of malignancy include the echogenic rind, architectural distortion, posterior shadowing, hypervascularity, ductal extension, or abnormal ductal changes, and calcifications. Again, very much like what you see with masses at ultrasound. And some studies have shown that the presence of some small cysts may suggest benign, like fibrocystic change. There will also be clinical variables, and this literature has shown that those can be predictive of malignancy. Of course, your palpable lump, nipple discharge. Those are the classic. So kind of what you already know about breast imaging, if you will. And of course, correlation with other imaging modalities. Studies have shown that distortion or asymmetry in mammography associated with this kind of ultrasound finding increases the chance of cancer. And along with abnormal enhancement at either contrast-enhanced mammal or MRI. There's actually literature on this subject. So two cases. Case number one. These are meant to be photographic enlargements of segmental pleomorphic calcifications. This patient presented with a palpable lump. You can see that in the triangular markers here, which are the BB markers. And on the left is your lateral medial. On the right is your CC. And the yellow is meant to show you the posterior extent of those segmentally arrayed calcifications. And the red is meant to show you the anterior margin. So segmental. And this is the ultrasound correlate. The red arrow here marks the nipple. And you can see kind of the extents being marked with the yellow arrows. This is not quite a mass, if you will, but definitely a finding. And it correlates with what we saw at calcifications at mammography. And palpable. Clinically important, that's palpable, as denoted here. And there are associated features at imaging associated with this category of lesion. The red here marks the echogenic line component, increases the chance of cancer. The yellow arrow here is meant to show you posterior acoustic and shadowing. Just some examples. And additional associated imaging features. These echogenic foci of calcifications. And on the right-hand side, the Doppler, showing you hypervascularity as one of the associated imaging features. And at biopsy, this was the case of ductal carcinoma in situ, DCIS. Case number two. And this is a case that started out with an imaging finding, ever, ever so subtle distortion that was seen on tomosynthesis in the middle here. And then the synthetic view. But and significantly on the left here, on your contrast-enhanced mammal, where the yellow arrow's marking, there's a subtle bit of enhancement that's associated with that subtle distortion at the other forms of imaging. And ultrasound shows something like this. Identifiable in two planes, but really seen well in one, primarily in one plane. Couldn't quite put a pulse on it in terms of the shape and margin. And on pathology, biopsy, this was a complex sclerosing lesion, radial scar, as the histology. Okay, so last topic, you know, we're going to talk about is lymph nodes. Of course, important because we know that most breast cancer metastasized by the lymphatic versus the hematogenous spread and definite and very multiple good studies showing that survival, of course, is correlated with nodal involvement. And this is data from the United States, the SEER Tumor Registry, Surveillance Epidemiology and Results. Even though there is, of course, screening mammography at the United States that we all strongly advocate for that's available, notice that at time of diagnosis, the extent of disease in 29% during this time period in the SEER Tumor Registry, it's already, it's not insubstantial. So 29%, nearly a third, will have regional lymph nodes at the time of diagnosis, even though we have a screening mammography program available. Just to show you that lymph nodes matter in terms of what we do quite a bit. So within BI-RADS, we're proposing to expand the discussion on lymph nodes and give more emphasis to location, okay? And that location being the intramammary node, axillary nodes, we're gonna talk about levels one, two, and three, make distinctions. And then the internal mammary node, which is meant to be shown here in the upper right-hand corner, along with this, which is the supraclavicular node, okay? So these, in yellow, are the additions beyond the current addition, if you will, the internal mammary node, supraclavicular node, and the axilla being broken down into the three surgical levels of one, two, and three. And a lot of this will be based on the cortical hilar relationship, morphologically assessing, at least at ultrasound. So here's the axillary node that demonstrates the compressed hilum. And of course, we know that all this matters because location, location, location, right? Location's what we're talking about. And location's demonstrated here anatomically. And here's the pectoralis minor muscle, which is the landmark that will help distinguish between the surgical levels one, two, and three. And all that matters because, in terms of the TNM staging, the N part of TNM, of course, is nodes, and the location matters, not just the number. Just for example, N1 disease is the ipsilateral level one or two, as opposed to N3A is the level three axillary node. And then N3C is ipsilateral supraclavicular node. So it's not a yes, no. It's not even just a number, but location, location, location. We know that this is the histology of a lymph node. And I just showed you the ultrasound correlate on the right, which, in this case, is a normal intramammary node, so showing you the hypocoic cortex, echogenic hilum, and of course, the afferent and afferent arteries and veins going in at Doppler. So in terms of cortical hilum relationship, it's going to be sort of a little bit of a progression of how abnormal, you know, going from the most benign looking to the most suspicious looking. Across here, first row, and then the second row. Most suspicious being completely replaced. No more echogenic hilum. Just all hypocoic cortex. Lots and lots of tumor, if you will, and that kind of gradations as you go through from a thin imperceptible cortex to a little bit thicker, focally thicker, and then hilum still seen, but really displaced, and then really just no hilum visible. And just to show, just for fun, let's see if this will work, a quick video on the sort of progression, if you will, at ultrasound. So remember, this is the pectoralis minor muscle. Internal mammary, supraclavicular, the different axillary levels, one, two, and three. And let's say that here's a tumor here in the lower medial breast, and let's just pretend that these are little tumor cells going into these, being in nodal deposits. Just ignore the top here, but in terms of just focusing about the morphology, that the cortical hilum relationship is being distorted as we have more and bigger and bigger evidence and involvement to this being completely replaced, okay? And we can see that on ultrasound. And why is that? Why does that matter? It matters because we can do things at ultrasound. It's accessible, you can reach it, and what is shown here is an internal mammary node between two ribs. I have shown in the yellow this hypoacoid cortex, this echogenic hilum. This is an internal mammary node that we see well at ultrasound. And this particular case had an ipsilateral cancer, and the size of this was a little more prominent. We biopsied this. Does this turn out to contain metastatic adenocarcinoma? So in this particular case, morphologically, at ultrasound, not sure, but biopsy showed that this was involved, and that affected the staging, right? At our institution, that also affects the management, but if nothing else, in everybody's institution, this affects the staging, the TNM staging. And of course, with ultrasound, we can do wonderful things. There's the ribs, and what I'm showing here is a very abnormal node that's completely replaced, and what's that wonderful thing? That wonderful thing, of course, is the real-time ultrasound-guided biopsy for tissue diagnosis, as manifested in this echogenic line that is the biopsy needle. Once again, giving us the diagnosis of metastatic involvement of this internal mammary node. So on that note, thank you very much. Now we will move on to the last of the modalities for us to MRI. And we will talk about some of the major significant and interesting updates to breast MRI. A reminder, these proposed changes are preliminary at this time. As you know, in BI-RADS, we have different levels of organization and categorization, so I'm going to approach this thinking about the changes to the different sections within breast MRI, and we're going to start with the clinical information and comparisons section, where the major update is the introduction that you've already heard a bit about from Dr. DeStunis of structured clinical indications. So what do we mean by this? Again, these are new cross-modality structured clinical indications for the reasons that we're performing our imaging tests, in this case, breast MRI. And we are encouraging people to report and use these major clinical indications categories, and when possible, specific subcategories. So for example, a major clinical indication of asymptomatic screening could include a description of the reason for screening, such as dense breast screening, and when possible, the relevant clinical history. And there are many benefits to this across modalities, which Dr. DeStunis has mentioned, provides much greater clarity for the reason that you're doing an examination for your patients and your providers and your partners, as well as allowing separate audits by these different indications, which have very different performance outcomes. And certainly that's important for us in breast MRI, where in the United States, we have only one code for breast MRI. There's no separate screening versus diagnostic MRI code. Now let's move into updates to the acquisition parameters, very important for us as a very technologic area, and these revised and expanded descriptions reflecting the continued progress of how we perform breast MRI and how we interpret breast MRI. So the acquisition parameter section has been revised and expanded. It includes the description of the standard full protocol contrast-enhanced breast MRI with at least two post-contrast series, but we also do describe abbreviated contrast-enhanced breast MRI, shorter, typically less than 10 minutes with at least one post-contrast series. And in addition, we talk briefly about these newer, faster hybrid techniques, which some are employing, which include very high temporal early series, sometimes called ultra-fast imaging. And because of faster sequences where you may acquire images very early, before the 60 to 120 seconds after contrast is administered, we're actually changing the name of what was initial phase enhancement to peak phase enhancement because there may be initial imaging before that 60 to 120 seconds. We know the term peak itself is not ideal as well because cancers can often peak before this as well, but again, just reflecting, there may be imaging that is performed more early on. We also talk about diffusion-weighted imaging as a complement to contrast-enhanced imaging for further characterization of findings seen with DCE, also being researched as part of non-contrast screening protocols. At this time, we are not introducing BI-RADS guidelines for how to report DWI, but we do reference the very nice USOBI International Consensus Statement, which does provide some structure for reporting DWI. Moving on now to the lexicon itself, this is, of course, how we describe the things that we see in the breast. We have updates in particular to the focus. The addition of T2 signal intensity, it is a scripter for masses, and then a separate lymph node section, which Dr. Leung has nicely prefaced. So first of all, in the lexicon, I want everyone to get used to the fact that the term focus is anticipated to be removed from the lexicon, and this is because, for many reasons, and in general, these tiny dots of enhancement are not clinically significant. They are typically part of background or other benign enhancement of the breast, and so we really want people to stop thinking about and focusing on foci. And in addition, with modern breast MRI techniques, we really should be able to characterize small findings that are less than or equal to five millimeters in size as a small mass that meets criteria for a mass, where you can say it has this shape and these margins, or if it does not, cannot be characterized in that fashion, it should be described as focal non-mass enhancement. So we really can and should be able to do that with modern breast MRI techniques. We also observe heterogeneous use of the term focus in practices in the literature. And importantly, and this is true for all of our areas, where we can continue to build upon our guidance and improve the lexicon, we really need future research, in this case focused on the predictive morphologic and kinetic features of small masses and non-mass enhancement, ideally in multi-site prospective studies. The next change to the lexicon is the introduction of T2 signal intensity as a descriptor for masses. We know that T2 signal intensity can be important when we're thinking about multi-parametric imaging. We know that both benign findings in the breast and malignant findings in the breast can be T2 hyper intense, or be bright on bright fluid sequences. But we also know that if a lesion, a mass in particular, a finding has other particular features, that T2 signal intensity is predictive of benignity. And in particular, a T2 hyper intense mass that is also oval and circumscribed and has homogeneous internal enhancement or dark internal septations has a very low probability of malignancy of less than or equal to 2%. So we are inculcating this use of T2 signal intensity as should be considered for such masses as it does predict benignity. T2 signal intensity should be described as hyper intense or not hyper intense and assessed subjectively at this time and categorized as hyper intense if the signal is as uniformly bright throughout and as bright as a normal appearing lymph node. And then as Dr. Leung nicely prefaced, we are introducing lymph nodes in much more detail and across modalities as a separate section. So for instance, for breast MRI now, you probably know that right now, lymphadenopathy is an associated feature, but that really underplays the importance of lymph nodes and the complexity of lymph nodes. So across modalities, lymph nodes will now be a separate section. And for that modality, we'll include the lymph nodes that are typically seen with that modality and they're gonna vary a little bit from obviously mammography and ultrasound and breast MRI. For breast MRI, what we will see will be intramammary, axillary and internal mammary nodes typically and we should categorize them as normal appearing or abnormal appearing. We are providing guidance for what the evidence currently tells us about what constitutes abnormal appearing lymph nodes on breast MRI. And at this time, abnormal appearing is subjectively asymmetric in morphologic features compared to ipsilateral or contralateral lymph nodes, particularly when the lymph node is ipsilateral to a current or prior breast cancer. So what do we mean by subjectively asymmetric? Well, subjectively asymmetric in terms of the cortex, the cortical thickening, but importantly, there is no quantitative threshold for breast MRI for the cortical thickening. If you take away just one thing from this, please do not use the three millimeters that you may use on ultrasound for cortical thickness for breast MRI. It is not applicable, it has not been validated. And this is the appearance of many normal lymph nodes. In addition, subjectively asymmetric can mean asymmetric rounding or absence of the hyla. But again, this should not be the sole criteria because the absence of the hyla or hyla not being visible is the appearance of many small normal lymph nodes on breast MRI. But here are some examples of what are abnormal appearing axillary lymph nodes. Again, these are subjectively asymmetric in morphology compared to the contralateral axilla. Both of these are ipsilateral to current left breast cancers. So in the left image, you can see cortical thickening, which is asymmetric compared to the right. And on the right image, you can see effacement of the hylum, which is asymmetric compared to the right contralateral axilla. And then as Jessica mentioned, we are emphasizing the importance of describing the axillary lymph node levels that are involved. This provides important anatomic staging information, important for prognosis and management. And on breast MRI, we often get a really good look at certainly levels one and two and often level three as well. And these are, as Jessica mentioned, relative to their positions, relative to the pectoralis minor muscle. And then we'll also describe internal mammary lymph nodes on breast MRI. Importantly, normal lymph nodes are frequently seen on breast MRI. So the fact that an internal mammary lymph node is seen on breast MRI does not make it abnormal or suspicious. What we are describing as abnormal appearing, again, is subjectively asymmetric in size compared to ipsilateral or contralateral lymph nodes, particularly when ipsilateral or contralateral, with ipsilateral recurrent or prior breast cancer. Data, again, for size thresholds remain very limited. We know from the literature that normal nodes can be seen, measuring up to nine to 10 millimeters in size. There's a very small study that we discussed showing that a size greater than or equal to five millimeters was the most predictive. But again, we have limited data for quantitative thresholds. But here's an example of an abnormal appearing left internal mammary lymph node that is ipsilateral to a current left breast cancer. And often the T2 sequence gives you a nice initial sort of heads up to look more closely at that lymph node. So pay attention to your T2 sequences. And then finally, let's talk about the reporting system itself. So this is our assessment and recommendations section. We have updates to categories three, categories four, and categories six in particular. So for category three, we know that we would love greater clarity on category three use for breast MRI. And we did review extensively the published literature. We know, however, that the data remain limited compared to what we have for mammography and ultrasound for what constitutes appropriate lesion types to place in Byrod's assessment category three. That remains the case now, even though we're 10 years since the last publication of our atlas. Because most of the studies still have been single site, retrospective with heterogeneous patient populations and clinical indications. We know from the literature though that category three can be employed with malignancy rates of less than or equal to 2% achieved, which is our threshold. We are stating a desirable goal for frequency of use in practice is less than or equal to 5% of examinations should be placed in Byrod's assessment category three. Urging caution on non-baseline examinations. There are some data indicating that frequencies of malignancy are higher for things assessed as category three if the breast MRI is not the baseline examination. And finally, if you do elect to use category three in extensive disease, which is not prohibited, typically though would warrant a discordant recommendation. So instead of short interval follow-up, which is a concordant recommendation for category three, the discordant recommendation for tissue sampling because at extent of disease, typically it's important to establish the diagnosis of additional findings. However, we do feel that there's sufficient data and expert opinion supporting the addition of, or the specification of a mass that is oval circumscribed and has homogeneous internal enhancement or dark internal septations and is T2 hyper intense and not new or increasing as a finding that is appropriate to go in category three. The use for other findings remains based on individual and practice experience and again, caution is urged because we don't have data to support these additional findings. And really important that you audit your breast MRI category three practice. We'll talk a little bit about the audit and outcome monitoring at the end of my talk for Dr. Eby. And this is going to be true across modalities, but again, you want to audit your practice, determine if your frequency of use is falling into the recommended benchmarks and your frequency of outcomes is falling into that less than or equal to 2% for malignancy. And if you are interested in more about lesions and breast MRI, there's a very nice review article in the September, October, the most recent journal of breast imaging, which I've referenced here. Moving on to category four, we're introducing the subdivisions of four A through C as encouraged as they have been for mammography and ultrasound. We have data showing that with breast MRI, we can also stratify lesions into these subcategories and achieve outcomes or likelihoods of malignancy that fall within the thresholds or cut points that we've established for mammography and ultrasound. And we know that use of these subcategories has potential benefits, including for more meaningful practice audit for RADPATH correlation and for setting patient and provider expectations. And then finally, let's talk about category six. We are trying to provide greater clarity here as to what is category six and what is above and beyond that and should be given a different assessment than category six. So we know overall and as has been the definition that category six is to be used for findings that are the known biopsy proven malignancy prior to definitive surgical removal. We do have some new definitions and guidance for reporting in particular additional ipsilateral findings. So what is reasonable to be lumped with and encompassed by BI-RADS category six. So in general, findings that are contiguous or diffuse typically same morphology to the biopsy proven malignancy for which you have a very high certainty of malignancy. Or alternatively, we're introducing a specific entity of the additional close finding, which is a finding that is within one to two centimeters of the known malignancy that increases the extent by less than one to two centimeters and you do not believe would significantly change management. This can be reasonably encompassed into that BI-RADS six definition and categorization. Important to fully describe the additional finding or findings and the relationships to the primary breast cancer. We are stating that the term satellite should be avoided because again, it doesn't have a definition and it can create confusion across different interpreters. And then what about things that don't fall into those categories, that you don't have a high certainty that they're malignancy or they're not within one to two centimeters of the biopsy proven malignancy. So now we provide greater clarity to some definitions for what count is above and beyond that. So in general, findings that do not fall into those categories that I just described and are one to two centimeters from the known cancer and or increase the extent by one to two centimeters and or would significantly change clinical management, particularly when different morphology, those findings are not category six. Those categories would be assessment four or five based on their MRI appearance. So the example I'm showing here, the patient has a biopsy proven malignancy, which is a mass, which is in the posterior breast shown in the middle image as well. But you can see there's seven centimeters of non-mass enhancement extending anteriorly from that. That is not bi-rod six, that would be category four or five. And then finally, as I said, I'm privileged to present a little bit of the work that Dr. Eby and his subcommittee have done. I'll tell you in just a moment where you can hear more about this. But again, tremendous thanks to our other member of the band, Dr. Eby and his band members, Drs. Bennett, Cohen, Plecha, and Sickles, who work on the audit and outcomes monitoring section, which is, as you know, as important, perhaps more important than our modality sections. So first and foremost, there's a new name. This has been called follow-up and outcome monitoring. It's simplified now to audit and outcomes monitoring, but with the same mission to provide a universal recipe for practices and individuals to evaluate, adjust and improve performance for patients. There are updates across many of the existing sections or components of audits and outcomes monitoring, including, of course, updated benchmarks for mammography, ultrasound, and breast MRI. And the benchmarks are wonderfully detailed. They include benchmarks for the particular way you might be performing mammography, for example, so DBT-specific benchmarks, or the way you might be performing breast MRI, such as abbreviated breast MRI benchmarks. So these are going to be incredibly helpful and impactful. Also, updates to the FAQs, the guidance section, what not to audit, and the modality-neutral indications for screening and diagnostic examinations. Some changes include, in particular, the changes to the high-risk definition and set of entities. So overall, the data dictionary lives within the audit and outcomes monitoring section, but the category of high-risk is going to have a new name, because, as you know, the term high-risk is pretty problematic. First of all, what do we mean by risk? We mean upgrade potential, but that can be confusing, because there are other risks, such as the risk of a subsequent breast cancer implied by a particular finding. And then the term high itself is challenging. What do we mean by high? And in fact, most of these entities are more likely to not upgrade than to do so. So the new name is Benign with Upgrade Potential, BWOP. And in addition, a couple of the existing entities that are now being moved from what was high-risk into the benign list of pathology codes. And if you wanna hear more about these BWOPs, I encourage you to attend the session tomorrow morning with Dr. E.B. Sattar and Sharma. And then finally, multiple new additions, and I'll touch on one in particular, which I mentioned previously, which is the audit of BI-RADS 3. This is going to be part of the basic clinical audit, which is required. It's a new addition to the basic clinically relevant audit. It is important, and this is obviously fully described in the updated section, to count only the initial BI-RADS 3 assessments. This will provide very important feedback with respect to utilization rates and outcomes, positive predictive values, and encourage the additional collection and publication of data for areas where we need it more, including ultrasound and breast MRI. And here's just an example. You won't take in all the detail, obviously, but of the beautiful flowchart that is present for how BI-RADS 3 can be audited. And again, Dr. E.B. reminds us that auditing improves individual performance in patient care. Auditing supports data collection and publication to update benchmarks and standards, and we really appreciate your comments and feedback. And I thank you very much for your attention.

BI-RADS

mammography

lexicon update

Dr. Mimi Newell

ultrasound

MRI

clinical indications

descriptors

audit and outcomes