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Breast Density: Implications, Controversies, and the Role of Ultrasound

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- Mammography is less effective in detecting malignancy in women with dense breast parenchyma.

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BACKGROUND• Mammography detects over 98% of cancers in women with fatty breasts but only about 48% of cancers in women with so    called dense breast tissue. 

• A study in 2004 demonstrated a 4-6 fold increased risk of breast cancer in women with 75% breast density. • In 2007 a study in JAMA showed breast cancer risk is increased by a factor of 5 in women with dense breasts.

This combination of factors makes the diagnosis of breast cancer more difficult in women with dense breast.

-Women with dense breasts are at an increased risk of having breast cancer.

An ACRIN study (6666) demonstrated that ultrasound detected an additional 4.2 cancers per 1000 in women who have dense breasts. These were women who had high risk and family history of breast cancer or other risk factors. A study in 2004 also found that, out of most of these cancers, 90% of them were very low stage. Either 0 or 1, meaning that they were very small and were node negative. Density and Increased Risk There have been a lot of studies that have shown that breast density is associated with increased risk of breast cancer. John Wolfe was the first one to notice this correlation. He published a paper in the Journal of Cancer in 1976 where he compared the incidents of breast cancer in various classifications of his densities.  He found that the highest incidents were seen in the most dense category. (Figure 1) - Wolfe JN. Risk for breast cancer development determined by mammographic parenchymal pattern. Cancer. 1976;37(5):2486–2492. - Wolfe JN. Breast patterns as an index of risk for developing breast cancer. Am J Roentgenol. 1976;126(6):1130–1137. 

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Dr. Norman F. Boyd, who is well known for his extensive work in the field of breast density, published this paper in the New England Journal of Medicine in 2007. He looked at matched pairs, over 1,100, of dense and fatty tissues to see if there is any association and he found significant association with an overall odds ratio 4.7 (Figure 2) - Boyd NF, Guo H, Martin LJ, et al. Mammographic density and the risk and detection of breast cancer. N Engl J Med. 2007;356(3):227–236.

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Another paper published in 2006 by Valerie A. McCormack, who did a large meta-analysis, in which they looked at 42 studies from the literature. That included more than 14,000 cases of breast cancers from 226,000 non-cases. (Figure 3) In their analysis they found that percent mammography density was consistently associated with an increased risk of breast cancer. That association was stronger for the general population, and was not affected by age, menopausal status or ethnicity. In their analysis they concluded that the increased risk could not be explained by the “masking” effect of cancer by the dense tissue. 

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Histology of ‘Density’ Histologically the lobules and their stroma make up most of the density seen on a mammogram. True ducts make up little of the radiographic density - Page DL, Winfield AC. The dense mammogram. AJR Am J Roentgenol 1986; 147:487–489 The increased breast density can be seen with increased stromal collagen which is sometimes seen with stromal fibrosis or with increase epithelial tissue which is sometimes seem with epithelial hyperplasia.

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Density Variation When looking at mammograms, breast imagers not only see a lot of variation in the amount of glandular density but also the distribution of the glandular density.

What Is "Breast Density"?

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Densities vary among the population but even in the same individual the density changes in different points in time.  For example, during the menstrual cycle density is in the highest luteal phase and falls in post menstrual period.  Density also changes with age, young women have dense mammograms and the density starts falling in the perimenopausal period and keeps falling in the postmenopausal period. Weight gain and weight lost can change the density as well. Rapid weight lost can significantly increase the breast density in a mammogram. Similarly, hormone intake, pregnancy and lactation can also increase the density seen in a mammogram.  Genetics also played an important role in determining what kind of density an individual is going to have. Percent Mammographic Density When assessing breast density, the term mammography density is frequently used. Percent mammography density means a "percentage of the total breast area that is occupied by radiologically dense tissue"

Mammographic Methods for Density Assessment  There are different methods used to assess breast density.   Qualitative Methods (subjective)- Visual estimation Quantification Methods- Planimetry – manually drawn density - Computer assisted interactive thresholding - Computer segmentation - Spectral mammography - Tissue equivalent phantom within the mammogram - Special Mammography software “SMF technology” Many of the Quantification Methods methods are FDA approved for clinical use. However large validation studies are still need to determine their efficacy in working clinical practice.   Qualitative MethodsDr. John Wolfe was the  first one, in the early 1970’s, to classify the mammographic pattern into four densities.   Wolfe Classification- N1   Mostly fatty  - P1v  Prominent duct pattern - minimal - P2 Prominent duct pattern – moderate to severe - DY Extremely prominent duct pattern (DY-splasia)

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Problems with Wolfe Classification The major problem with the Wolfe classification is that it has a large Inter and Intra observer variability. Wolfe Classification- Inter-observer agreement of 52%–97%  - Intra-observer agreement of 69%–97% The case control and cohort studies subsequently showed that the results were inconsistent and the risk association was not as strong as originally shown by Dr. Wolfe.   - Oza AM, Boyd NF. Mammographic parenchymal patterns: a marker of breast cancer risk. Epidemiol Rev 1993; 15: 196–208- Saftlas AF, Szklo M. Mammographic parenchymal patterns and breast cancer risk. Epidemiol Rev 1987; 9:146–174 Qualitative Methods In 1993, the American College of Radiology issued their first BIRADS (Breast Imaging Reporting and Data System) classification about breast density.   BIRADS Classification- Category 1 (Predominantly fatty) - Category 2 (Scattered fibroglandular densities) - Category 3 (Heterogeneously dense) - Category 4 (Extremely dense)

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ACR - BIRADS BIRADS takes into account the percentage of the glandular density present on a mammogram but it is assess visually by a radiologist.   - Almost entirely fatty replaced <25% fibroglandular (ACR category 1) - Scattered fibroglandular densities 25%-50% fibroglandular (ACR category 2) - Heterogeneously dense 50%-75% fibroglandular (ACR category 3) - Extremely dense >75% fibroglandular (ACR category 4)

Problems With Density Evaluation Methods Inconsistency in Methods Used Visual Assessment Wide variation in literature for categories (4 – 20 cat) Wolfe classification (4 categories) Tabar classification (5 categories) Boyd classification (6 categories) BIRADS classification (4 categories) Efforts started in early 80’s to find a method that is reliably consistent. Problems with BIRADS Density Evaluation BIRADS has its own issues as well. Many studies have shown that overall inter-observer agreement is very modest. ACR published their first density measurement criteria of BI-RADS in 1993 - Overall inter-observer agreement: 0.42 – 0.59 - Berg WA et al. Breast Imaging Reporting and Data System: Inter- and intraobserver variability in feature analysis and final assessment. AJR Am J Roentgenol 2000; 174:1769–1777- Kerlikowski K et al. Variability and accuracy in mammographic interpretation using the American College of Radiology Breast Imaging Reporting and Data System. J Natl Cancer Inst 1998; 90:1801–1809- Spayne M et al. Reproducibility of BI-RADS Breast Density Measures Among Community Radiologists: A Prospective Cohort Study. The breast Journal. 2012;18:326-333

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We have problems in assigning density, and there has been a lot of documentation about Intra-observer, Inter-observer, and other technical issues.

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Problems with Visual Density Assessment What is the inaccurate risk in assessment by visual density method?  The problem is it’s a 3D volume of the breast, which is projected onto a 2D image, and these images do not incorporate the breast thickness for their assessment.  The beam quality is not taken into account and sometimes image contrast and position of variation can also change the appearance of the density on mammogram which can be different from one year to another. Some of the data in the literature is done on film screen while the more recent data is on digital. There is not a lot of prospective studies to show us that the assessment pattern is similar on film screen and digital mammograms.   Density Assessment is Not a Perfect Science

INTER-Observer:  Inter-observer variability suggests that a density reading by various MDs will vary depending on many factors.

A recent study demonstrated only 61% agreement between radiologists.

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INTRA-Observer: Intra-observer variability suggests that a density reading by the same MD may vary depending on when the mammogram was read. From one year to the next we have seen the same image from the same patient may look dense one year but not dense the next year. (Figure 4) There can be 20% variability between the same radiologist and the same images. We need to find a way of making this less subjective and more objective.

There are now computer programs being developed that would hopefully take the subjective nature out of the equation. These programs are now only just being made available to radiologist, but they should be a very exciting addition to the field of density of the breast. Also making it much easier for radiologist to interpret more objectively what the density of the breast tissue is.

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There are two commonly used volume based software. Volpara and Quantra software. These work on raw data and incorporate information from CC and envelope both views. It also takes into account the thickness of the breasts so they can accurate access the volumes. However in clinical practice we have seen that the values of percent densities seen by these software are much less than what’s access by the BIRADS categories.

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Volume Based• Volpara software• Quantra software - Works on raw data - Incorporate information from 2 views - Takes into account breast thickness / volume - Not as affected by changes in the beam quality - % Values << BIRADS

Quantitative Methods Area Based• Cumulus software
 - Planimetry - Hand drawing - Digitization of film screen - Interactive thresholding - Computer segmentation There are many quantitative methods that have been used in the literature and some of the initial software used area base measurements. Cumulus was the first one in the market that used the planimetry. Their initial software used hand drawings on the films or digitization of film screens. Later software came which used interactive thresholding and computer segmentation for their analysis. 

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A paper came out where it tried to use automated ultrasound for the assessment of density and found good correlation with MRI. (Figure 6)

Spectral MammographySpectral mammography is another method relatively new that uses dual energy acquisition and photon counting technique for accessing breast density. Density Estimation on Other Modalities Efforts have been made to estimate breast density by other modalities such as:
 - Ultrasound - Breast magnetic resonance imaging (MRI) - Tomosynthesis MRI, which is volume based, is meant to be more accurate accessing the volume density; however because its a very expensive modality it cannot be justified even for its accuracy. (Figure 5)

- Density can also be assessed on ultrasound - Automated US showed good correlation with MRI (R = 0.9) 
- Moon W et al. Comparative study of density analysis using automated whole breast ultrasound and MRI. Medical Physics. 2011;(38):382-389

What Can We For Patients With Dense Breasts? Offer them additional screening test such as - Ultrasound - Breast MRI - Tomosynthesis Additional Screening Tests: Ultrasound Screening  ACRIN 6666 trial (Berg. Et al.)By adding US to mammography: - Cancer found by mammography alone = 7.6 / 1000; - By adding US = 11.8 / 1000; - Additional cancer detection by US = 4.2 / 1000; -Berg WA, Blume J, Cormack J, et al. Combined Screening With Ultrasound and Mammography vs Mammography Alone in Women at Elevated Risk of Breast Cancer. JAMA. 2008;299(18):2151-2163 Ultrasound screening was a large part of the ACRIN 6666 trial, lead by Dr. Wendie Berg. The data was published in 2008, showed that by adding ultrasound to mammography they found approximately 4 per 1,000 additional cancer in this trial.   Additional Screening Tests: MRI Screening  ACRIN 6666 trial (Berg et al.)- Supplemental yield of adding single MRI screening to mammography and US = 14.7 /1000 - Sixty-eight screening MRI examinations are needed to find 1 additional cancer in negative mammography and ultrasound. -Berg WA, Zhang Z, Lehrer D, et al. Detection of breast cancer with addition of annual screening ultrasound or a single screening MRI to mammography in women with elevated breast cancer risk. JAMA. 2012;307:1394–1404

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There was a component in the ACRIN 6666 trial where they used single MRI screening in addition to mammography and ultrasound and they found 14.7 cancers per 1,000 women. However they did mention that approximately 68 screening MRIs were needed to find 1 additional cancer in the setting of negative mammogram and ultrasound.   Additional Screening Tests: Tomosynthesis - Skaane et al. (> 12,000 examinations)  -  Thirty-one percent increase in the cancer detection rate with addition of tomosynthesis to mammography. - Philpotts et al. - Recall rates decreased by 40% by adding tomosynthesis. -Skaane P, Gullien R, Eben EB, et al. Reading time of FFDM and tomosynthesis in a population-based screening program. Radiological Society of North America annual meeting. Chicago, IL, 2011.-Philpotts, L, Raghu, M, Durand, M, et al. Yale University School of Medicine. Initial experience with digital breast tomosynthesis in screening mammography. Presented May 3, 2012 at American Roentgen Ray Society Annual Meeting. Efforts have also been made to utilize Tomosynthesis as in additional screening test.  Studies have shown significant increased cancer detection by adding Tomosynthesis and decreased recall rates by adding Tomosynthesis to mammography.

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Breast-Specific Gamma Imaging • Radiation dose is an issue  - Recent protocols have reduced radiations dose but radiation dose, but the radiation dose may need to further come down. • Addition of gamma imaging to mammography in dense breasts  - Increased cancer detection 7.5 / 1000 women screened (95% confidence interval: 3.6, 15.4).  - Rhodes DJ, Hruska CB, Phillips SW, et al. Dedicated dual-head gamma imaging for breast cancer screening in women with mammographically dense breasts. Radiology. 2011 Jan;258(1):106–118.  Gamma Imaging has been performed by some but the radiation dose is still an issue and it needs to come down if this modality is to be used for screening purposes.  There was one study and they showed significant increase in cancer detection using this modality. Problems in the Density Literature • Inconsistencies of the methods employed for measuring density • Inherent issues with breast density reporting  - 3D volume projected over 2D (area based assessment) - Density variations due to position and technique - Interobserver and intraobserver variability - Possible variation between film screen and digital mammogram • Volume based modern / quantitative methods - No direct prospective studies available to show the association

Screening Breast Ultrasound in Clinical Practice In Connecticut legislation has allowed and mandated a procedure called breast ultrasound bilateral in women who have dense breasts tissue. Why In Connecticut? This has become such an important issue particularly in Connecticut because breast cancer, which is the most common female malignancy and the second leading cause of death of women in the United States, has the 2nd highest incidence of breast cancer and ranks 16th in the nation for breast cancer mortality. Which puts it above the national average. Connecticut General Statute Sections 38a - 503 and 38a-530 
Sleeper Legislation! In 2005, Connecticut passed its very first legislation regarding breast density and breast ultrasound. They required insurance companies to provide coverage for comprehensive ultrasound screening of an entire breast or breasts if a mammogram demonstrates heterogeneous or extremely dense breast tissue based on the BIRADS (Breast Imaging Reporting and Data System) established by the American College of Radiology (ACR). This applies to the two most densest types of breast tissue (over 50% to 75% and greater then 75%).  Connecticut was the first state in the nation and up to now only one other state has such legislation.

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Public Act 09-41 -Signed into Law by then Governor Rell May 2009 In 2009, Connecticut then became the first state to mandate communication of breast density to their patients, and this too was based on the American College of Radiology's Breast Imaging Reporting and Data System (BIRADS) coding system.  Effective Date: October 1, 2009 The Radiological Society of Connecticut’s Response When the legislation was proposed in 2008 the radiologists of the state felt that this might be premature. We were concerned that we were not really ready to have such a legislation passed and that this mandate was going to be very difficult for us to accommodate and may raise problem with our patients and our referring physicians. We testified that we were concerned that there were many potential "false positives" and on how we were going to implement this legislation. We didn't know whether it would actuality improve mortality by finding these small cancers and if we we were actually going to be able to find small cancers. We attempted to insert verbiage that mandated all sites performing these ultrasounds were ACR accredited, but that was not included in the final wording of the bill. Once the ACRIN study was published, in the spring of 2008, we felt that we must go along with this legislation and so we accepted as it was written.

Audio Description by Dr Weingert

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Concerns• Office  • Technical Issues • Referring Medical MD Issues • Patient There were various aspects that had to be taken into account once this law was passed that radiologist had to put into effect into their offices in order to provide this information to patients and then follow through in an appropriate matter. There were concerns regarding our own offices. We had technical issues in terms of how to actually perform these tests. There were concerns regarding on how our referring physicians would accept this situation and how they would react to it and to their patients. We also had concerns regarding our own patients and their concerns and fears, and how they would respond to having this new test included in their routine mammography testing.  Office Concerns: Scheduling Billing Issues Although the state mandates that insurance companies allow for these ultrasounds to be performed, there is no true screening code. There is a: - CPT Code for Breast Ultrasound – 76645 - ICD-9 Code Inconclusive Mammogram due to Dense Breast - 793.82 - Other Screening Breast Exam - V76.19

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Paperwork The paper work also needed to be revised. We needed new letters that we would include to our patients and to our referring physicians that included the verbiage of statue. We also were mandated, in some ways, to help make it easier for our referring physicians. Therefore we came up with a new requisition order that included a "Reflex to Ultrasound if Dense". This allows the referring physicians, at the time of the patient screening mammogram, to check a box that whether the patient did or did not have a dense breast, that it didn't matter that they had already ordered the ultrasound and it allowed for flexibility and ease for both the patient and the radiologist involved. Technical Issues Study performed by sonographer or radiologist
 - Are the technologist adequately trained to perform this test? - Handheld versus Automated? Right now most of these studies are perform by hand held screening probes, which is the same way when we do any kind of ultrasound of the breasts. There has been a lot of research lately regarding automated breast ultrasounds. Although we don' have that much data yet this may actually facilitate our ability to do these tests.  Documentation- What images are obtained and stored?   - 12,3,6,9 o’clock or more? Because these test are done as hand held images we need to decide what documentation we need to provide. In my practice we film images at the 12 o'clock, 3 o'clock, 6 o'clock, 9 o'clock and right under the aralia. We also image the axilla. Other practices may chose to do more or less imaging. The important thing is that there are comparable images available when the patient comes back for her follow up ultrasound in a year or two.

How many can be performed in a day?-Sonographer fatigue It is also important that the technologist is not allowed to get to tired doing this test. It's extremely stressful because they are the first line of approach when these patients are having this post screening ultrasound performed. There is a significant amount of both physical and mental fatigue that the technologist might have because they are actually the first person looking at the ultrasound that they relay to the radiologist what findings they have and then whether or not we need to go in and review these cases personally. In my practice we allow our technologist to do only between 6 and 8 a day, obviously they are also doing a lot of other ultrasounds during the coarse of the day, so we break up this highly repeating study with other imaging that they are doing.  Protocols for documentation  - Significant findings versus “ditzels” (false positives) We also needed protocols for documentation. We knew that there was going to be a lot of false positive that could happen. Little, what I like to call, "ditzels" that we see in the breasts. Tiny benign solid lesions that really don't mean very much. Because the technologist is the one doing the study we needed to become able to reinsure them whether or not they need to document every one of those little solid or cystic masses. Problems in assigning density: - Intraobserver discrepancy; - Interobserver discrepancy; - Technical problems.

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Referring Physician Concerns  Initially our referring physicians were quite skeptical and they were worried about the recalls, unnecessary biopsies, costs and their own fears of litigation.  As patient demand increased this fear was slightly decreased. “Reflex to Ultrasound if Dense”  We also made it easier by coming up with the ultrasound requisitions that allow radiologist to not be bothered so often in their offices, so they could order this study the same time as the mammogram. We established protocols for scheduling, the ultrasound, that also made it easier for their offices when we would call for their orders. We would document that the mammogram was either "negative" or "dense" and then bring the patient back on our own. One issue was still a problem; when we recalled the patient for additional views, because we found something on the mammogram. This was not technically a negative mammogram but what we do is to bring the patient back for their additional views and then at the same time, if the patient has dense tissue, we do the bilateral breast ultrasound. Therefore eliminating the need, for the patient, to come back a third time for additional imaging. All this relieves the referring physician of a lot of involvement, concerns and risks.  - How often does this screening breast ultrasound need to be performed?  - Should we do it the same time as the mammogram or should we break it up with in six-month intervals? 
 We have found that doing it every year is actually quite beneficial.

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Patient Concerns The patient issues have been less complicated. Initially they were skeptical and but then asked for the test themselves as more information became available.  They were relieved if it was negative and accepted having to have a biopsy performed if we found an abnormality. If we found a small cancer they were relieved because this was not a cancer that we would have found as quickly had we not done this test. There other concerns were about reimbursement issues. 

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DATA COLLECTION PROJECT: YEAR ONE* and TWO** Since Connecticut was a rather small state it would be better to gather data from clinical practices from around the state and look at what happen to their data and what kind of findings they had. This would be the largest amount of data ever collected on this topic. 
 Purpose:To determine if screening breast ultrasound in women with mammographically normal but dense breasts is useful for the detection of breast cancer Objectives- To determine positive predicted value (PPV), negative predicted value (NPV),    sensitivity and specificity of screening breast ultrasound - Estimate cost, ideal screening population, benefits, and risks

 *Weigert, Jean and Steenbergen, Sarah.  The Connecticut Experiment: The role of Ultrasound in the screening of Women with Dense Breast. Breast Journal. 2012; 18.6;517-522.
**Steenbergen, Sarah and Weigert, Jean presented ARRS Washington D.C. April 2013 We requested data from practices around the state both clinical and academic and had positive responses from 6 large practices with a total of 9 offices. We documented the number of screening mammograms, the number of screening ultrasounds, and looked at what their BIRAD designations were and how many biopsies were performed.
 In patients with cancer we requested additional information regarding: - Stage/lymph node status; - Size and type of tumor; - Age of the patient; - Risk status of patient.

Results: Year 1

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Analysis: Year 1 
The statistical analysis indicated: 
- Positive Predicted Value (PPV) - 6.7%
    28/418 - Negative Predicted Value - 99.9%
           7450/7451 - Sensitivity - 96.6%     28/29 - Specificity - 94.9%     7450/7852 We found an additional 3.2 cancers per 1,000 patients. In a screening population we find between 4 to 6 additional cancer per 1,000 on mammograms. This almost doubles the amount of cancers that we were finding in the first year. Only 30% of patients, who fulfill the criteria, came in for their screening breast ultrasound in the first year. We anticipated that in subsequent years we would have more patients coming back and the cancers would be smaller in size and there would be fewer false positives. There was only one patient who had positive lymph nodes in this whole patient positive population. We were finding very early low-grade cancers.

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Analysis: Year 2 
 The statistical analysis indicated: 
- PPV: 9% - NPV: 100%  - Sensitivity: 100% (not all followed)
 - Specificity: 96%  We found 3.8 cancers per 1,000. This included high-risk lesions, papillomas and atipias. We included those because those are patients that required excisional biopsies. 45% of women now fulfill the requirement for coming in, up from 30%. This was a combination of prevalent and incident cancers and none node positive.

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Yale University Study* Year 1 - 900 ultrasounds - 3.2 cancers /1000 Year 2 - 415 patients returned for a subsequent ultrasound - 4.3 cancers/1000** 
All their cancers were small and node negative.  *Hooley RJ, Greenberg KL, Stackhouse RM, et al. Screening US in Patients with  Mammographically Dense Breasts: Initial experience with Connecticut Public Act 09-41 Radiology, 2012:265(1):59-69. ** Presented RSNA 2012 What have we learned? We are finding cancers before they can be found on mammography. They are small, they are node-negative, and as time progressives we are finding more cancers. This isn't just a statistical apparition in the sense that these patients never had an ultrasound before. These are patients who are returning for additional ultrasounds and we are finding new cancers. This is very important and quite surprising.

State Initiatives So where are we nowwith legislation? In June 2011, Texas passed a law that stated they had to tell patients their breast density. California and New York also passed legislation in January 2013. There’s legislation pending in:
Pennsylvania, Ohio, Maine, Massachusetts, Maryland, New Jersey, Michigan, Illinois, Indiana, Iowa, North Carolina, South Carolina, Georgia, Florida, Alabama, Tennessee, Utah, Nevada, and Oregon. Washington and Delaware are interested in the legislation. By the time you hear this lecture many more of these state will have already have passed their legislation.

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Additional Activity • There is a federal bill that has been introduced by Congresswoman Rosa Delauro of Connecticut. She has endorsed a bill that the entire nation would have to pass this concept of giving patients their breast density. No one knows at what point this bill might be passed but it is something that she is pretty passion about. • The Mammography Quailty Standards Act (MQSA) is addressing the issue of adding language regarding breast density to the plain language reports that are now sent to all patients. • New Connecticut legislation covering MRI In July 2011 an additional legislation was passed in Connecticut mandating MRI imaging be paid for if patients qualify under this density requirement.  Public Acts No. 11-171 and 11-67     “Comprehensive ultrasound screening of an entire breast or breasts if a mammogram demonstrates heterogeneous or dense breast tissue based on BIRAD established by the ACR or if a woman is believed to be at increased risk for breast cancer due to family history of breast cancer, positive genetic testing or other indications as determined by a woman’s physician or advanced practice nurse and magnetic resonance imaging in accordance with guidelines established by the American Cancer Society or the American College of Radiology”

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The patients who have fatty reports may get a false sense of security. Some experts think that significance of density as a risk factor is still debatable or controversial. There is not enough data to support that high density confers sufficient risk to warrant additional screening. A dense report in some patients may cause undue anxiety that may demand supplemental screening. Reimbursement issues for supplemental screening.

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But the controversy is not over… Experts are still debating on the pros and cons of this legislation, and whether these laws are even necessary or possibly harmful for the patients. (Figure 7) - Irshad   Concerns for These Laws  The ACR has stated its position as well and the ACR statement can be seen on the their website. It is a detailed statement and the concerns they have raised are due to the fact that the assessment of the breast density is not reproducible. 

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THE FUTURE? Automated technology so that the technologist is not the one performing this test as a first line. That there is a simple automated procedure in which the technologist actually might be performing the test but isn't really doing as much work to do the test. There are now several different companies that have been developing this technology and that is something we will be seeing a lot of in the near future. Computer derived breast density this is now available and will make it much easier for us to be less subjective into defining which patients have dense breast tissue. Having a screening breast ultrasound code so that we can truly be able to submit this as a separate diagnostic code to our insurance carriers. The concept of screening breast ultrasound as an accreditation through the American College of Radiology or other organizations like the American Institute of Ultrasound in Medicine. Accreditation and documentation through the federal Mammography Quality Standards Act (MQSA). Data Tracking; it is clear that in the first two studies, that were performed in Connecticut and at Yale, that we were finding smaller cancers and over time fewer false positives, fewer false and unnecessary biopsies. Also to be able to track mortality statistics over time. It makes sense that if we find small node negative cancers that these patients will have improve mortality. 

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