by Keith Loria

Note: This report originally appeared in the July 2008 edition of DOTmed Business News. A list of registered users that provide sales & service can be found at the end.

Mammography appears to be on the radar screen of every imaging modality today. While the traditional mammogram has helped lower breast cancer deaths by as much as 30 percent over the last two decades, as many as one in five cancers, nevertheless, are still overlooked. That is why all the other major imaging modalities are aggressively being assessed - both for their diagnostic and therapy-management capabilities.

"I think an important message is that we've really evolved tremendously from the old mammography that really started only 25 years ago. Today we're using a whole compendium of different modalities that allow us to improve the detection of breast cancers and find them earlier and manage patients better," says Dr. Ellen De Paredes, chair of the ACR Breast Imaging Communication Committee. "A lot of these other modalities are really aimed at trying to help manage the treatment and decide what's the best surgery for patients. Is breast conservation the best thing, or are there other diseases, which means some other surgery would be better? We've really advanced a lot in the field of breast imaging, which I think is an exciting thing and it's helped educate the public."




According to Jim McGinty, President of Digitec Medical, a sales and service organization focusing on breast imaging equipment, there are a lot of exciting things going on in breast imaging in the first decade of the 21st century. "There is breast MRI and three dimensional imaging methods coming out with
enhanced imaging," he says. "They all hope to improve image quality and reduce patient dose. Then there are improvements in CAD where a computer looks at images and suggests where doctors should look."

Every modality - from film and digital mammo, to MRI, CT, ultrasound, and nuclear medicine - has its advocates. Ask five different radiologists which is best, and you're likely to get five different opinions as to where imaging is headed in the future.

"There is going to be a shakeup in breast imaging, and the reason you have 5 to 6 modalities to choose from is that no one has any real, conclusive data that any one is a better screening tool than the others," says Dr. Bruce Schroeder, Director of Breast Imaging at Eastern Radiologists, Inc. "No one really knows which one is best or whether you need more than one."

Digital vs. analog - the cost/benefit debate continues

For women who are 40 or older, a mammogram is recommended at least once a year - but for most women, it's not necessarily that important whether it is an analog or digital image.

Until eight years ago, all mammograms were done with film. Then in 2000, GE pioneered digital mammography with the introduction of the first full field digital mammography unit, and the digital industry has exploded. Manufacturers such as Hologic and Siemens joined GE in creating a strong marketplace for digital mammo.

"Almost the entire industry has gone digital because it offers a lot of efficiency," says Pat Hall, Director Product Communication and Professional Relations for Hologic, a leading OEM of digital mammography equipment. "What makes digital better is that you can see things much more clearly and more quickly. It also significantly reduces the recall rate in mammography. That's a major advantage. Anytime a woman doesn't have to go through the anxiety of thinking something is wrong, that's a major advancement."




As with film mammography, optimal positioning and compression are critical in identifying a suspicious lesion. Unlike an analog image, with digital mammograms the technologist is looking at the image within seconds. "They can see if the
woman moved during imaging, or if the breast tissue was properly positioned, or whether they got the entire breast or not - with film it takes a few minutes," Hall says. "It's a much faster process, so there are patient advantages, doctor advantage, and workflow advantages. You don't have chemicals, you don't have film, and you don't have film storage to worry about."

On the other hand, you have a more expensive piece of equipment - digital imaging is about three times as expensive as analog units - and you'll also need a PACS system in place to store and transmit the images.

"I think cost is an issue for many hospitals and many facilities because they have existing film equipment in good condition and it's fine to use. But when it becomes time to replace that equipment, I think most people will move towards digital," De Paredes says. "I do think digital is the wave of the future."

Last year, 92 percent of mammography systems (of the 1,776 units) sold in the United States were digital, and it appears most people are convinced this is the way to go.

According to Karen Schmitt, Director of the Columbia University Breast Cancer Screening Partnership, the convenience far outweighs the cost. "Two radiologists could be looking at the same film at the same time from two different places on the planet. That's really helpful, especially if you are going for a second opinion or you are in a rural area," Schmitt says. "Plus, there aren't a lot of large storage costs because you are storing everything on disk."

The American College of Radiology Imaging Network (ACRIN) in 2005 released the results of one of the largest breast cancer screening studies ever performed, and it is referred to by most experts when discussing the differences between film and digital mammograms. "Digital was shown to be superior to film mammography in some subsets of women," says De Paredes. "In my own practice I use digital exclusively. I think it's the future of mammography as most of general radiology has become."

The primary finding of the study was that, for the entire population of women studied (49,528 women), digital and film mammography had very similar screening accuracy.

Where digital was deemed significantly better (28% better) was in women under 50, those with dense breasts, and those pre- or perimenopausal (defined as women who had a last menstrual period within 12 months of their mammograms).




"There are just a few new analog systems being placed today," McGinty says. "For women under 50 with dense breasts, it has been found that digital is probably a better way to go because of its ability to differentiate the different shapes and structures in the dense tissue. Once you get above that, it's a wash and it doesn't make a whole lot of difference."

The MRI option

MRI can be used along with mammograms for screening women who have a high risk of developing breast cancer, or it can be used to better examine suspicious areas found by mammograms. MRI is also used for women who have been diagnosed with breast cancer to better determine the actual size of the cancer and to look for any other cancers in the breast.

"I believe the breast MRI is really used once you establish there is a problem and you need to see the extent of that problem," says Peggy Pust, Director of Imaging Services at Monongalia General Hospital. "Certain cancers will occur in the other breast. Many times the doctors won't do the surgery until they are fully aware of all the cancer that is there."

Recent studies conducted by the National Cancer Institute (NCI) found that MRI was not only more effective than mammography, but also better than ultrasound or other clinical breast exams in finding breast cancer in women who had the screening.

The study showed that MRIs were accurate in detecting breast cancer in 83 percent of the 54 women who participated. The MRI returned a false positive in 17 percent of its diagnoses.

"You inject a contrast agent, and as it's going through the body, there's increased vascularity and the uptake of the solution is greater if a tumor is present. That shows up as a hotspot on an MRI, so you can make a more definitive diagnosis by looking at that," says Hall. "You certainly would not think about doing an MRI for every single situation. It's very expensive and not all that pleasant a procedure, and not required to do a basic screening. It's typically used as a second-step diagnostic tool. If you find something on the mammogram that looks suspicious, this gives you new avenues to explore it."

MRI has shown usefulness as a next-step imaging modality for difficult- to-diagnose cases, as well. Much like X-ray mammography, breast MRI relies on anatomical or structural information, but provides much more detailed images. It is limited, however, by its highly variable specificity, which can range from below 37% to 97%. Combined with its high sensitivity, MRI produces a high false positive rate. It also is sometimes difficult to schedule, and may require multiple days to complete.

The major disadvantage of breast MRI is the cost, which is about 15 times that of a basic mammogram. The entire exam could run anywhere from $1,000 to $1,500.

"If money was no object and time was no object, I guess MRI would be the answer," Schroeder says. "If you had an unlimited number of scanners and slots and people to read it, but that's not going to happen, it's not practical."

Ultrasound has its own niche

Ultrasound has become a valuable tool to use with mammography because it is widely available and less expensive than other options. The use of ultrasound instead of mammograms, however, is not recommended.

"The current standard way [ultrasound is used] is generally after, or in conjuncture with, mammography. The accepted path for a woman is: first, she is screened with traditional mammography. Some of these women have abnormalities on their mammograms that can be further defined by ultrasound, so they go on to have an ultrasound." says Dr. Beverly Hashimoto, a radiologist at Virginia Mason Seattle Main Clinic. "The only exception to that is when a patient has something that can be felt, a lump, and they are very young, some of those patients will go to ultrasound early. But even women who have lumps who are over 40 will have both mammogram and ultrasound."

Usually, breast ultrasound is used to target a specific area of concern found on the mammogram. Using ultrasound, physicians are able to determine that many areas of concern are due to normal tissue (such as fat lobules) or benign cysts. For most women 30 years of age and older, a mammogram will be used together with ultrasound. For women under age 30, ultrasound alone is often sufficient to determine whether an area of concern needs a biopsy or not.

"Basically when you see something on a mammogram, an ultrasound can clarify it," Hashimoto says. "An ultrasound can show a lot of different things. It can distinguish fluid from solids and define solid objects much better."




In some cases, ultrasound is not able to determine whether a mass is cancerous, and a biopsy will be recommended. Many calcifications seen on a mammogram cannot be seen with ultrasound. Some early breast cancers only show up as calcifications on mammography.

Ultrasounds also take longer to do. Many breast radiologists do the ultrasound
imaging themselves (instead of using a technologist) so it takes more
physician time.

"When we target a specific area it doesn't take all that long, but if we need to scan the entirety of both breasts, it can take quite a while, especially with larger breasts," Schroeder says. "I can easily read 5-10 mammograms in the time it takes to read one ultrasound. It's time consuming and you get a ton of false positives. I don't think that will be the answer."

Clinical trials are now looking at the benefits and risks of adding breast ultrasound screening to mammogram screening for women with dense breasts who are at a higher risk of breast cancer.

"There was research that came out [in early June of this year] indicating that women at higher risk - especially younger women who tend to have denser breast tissue - would benefit from mammography coupled with ultrasound screening. The study indicated that there was a three-times higher breast cancer detection rate when both tests were used, meaning that something that wasn't seen on the mammogram was seen on the ultrasound," Schmitt says. "There was a higher capture. That is not policy, but it was a huge study so it will have some impact on how screening will be done for higher risk women."

Along with the higher cancer detection comes a lower specificity. "When we recommend biopsy for an abnormality seen on a mammogram we find cancer in around 20-25 percent of women," says Schroeder. "When we biopsy something seen in an ultrasound we find cancer less than 10 percent of the time."

When you talk about high risk women, you are talking mainly about women who have first degree or multiple second degree family members with breast cancer. The other high risk category is the prior existence of breast cancer in one breast.

CT is making a strong case for itself

There are some who believe that using CT is the best modality when it comes to breast imaging for diagnostic purposes, and there are plenty of studies going on today that are trying to prove this theory.

A breast CT scanner takes images of virtual "slices" of the breast-about 300 images per breast. Computers then assemble these images into highly detailed, three-dimensional pictures that provide a more unobstructed view of breast tissues than can be seen on mammography.

Schroeder has invested in CT because he believes it takes a good modality and makes it better. "I'm looking at this and saying, X-rays work now, so a better X-ray seems to be the most logical next step," he says. He admits, however, he has no way of knowing how popular CT mammo will become. "A breast CT with a contrast agent will provide at least as much information as MRI, if not more - but that's not definitively known yet, because it has not yet been fully studied."




De Paredes says there is some new research using high resolution CT that is promising, and that breast cancer screening using new CT imaging devices may be more accurate than standard mammograms, and much less painful.

Among those studies is the 2006 research of The Cone Beam Breast Computed Tomography scanner, which takes 360-degree views of breast anatomy, with no need to compress the breast between cold glass plates. It is a new kind of test to
screen for breast cancer. "We have one case in which a cancer shows up phenomenally well using this new imaging system, whereas when you look at the same lesion on a mammogram, it is hard to detect," said study leader Dr. Avice O'Connell, Director of Women's Imaging at the Highland Breast Imaging Center, on release of the study.

Their new scan produces three-dimensional pictures, which are better at showing whether a spot on the X-ray is benign or malignant, the researchers at the University of Rochester in New York said. It can also provide pictures of tissue
around the ribs and outer breast toward the armpit, where 50 percent of cancers are found, the researchers told a Radiological Society of North America meeting in Chicago.

PET/PEM has a role both before and during treatment

According to Jacqueline Brunetti, M.D., Associate Professor of Clinical Radiology, Columbia University, PET imaging is a clear advance in the approach to staging and monitoring breast cancer. Positron imaging offers better accuracy than conventional imaging in the identification of metastatic disease both in the initial staging of breast cancer and in follow-up.

In the future, further refinements in scanner technology and new radiopharmaceuticals will likely result in better identification of smaller lesions. Dedicated breast PET/CT or PET/Mammography units show promise in improved detection in primary breast cancer, while also providing a method for image guided biopsy.

Also known as PEM (Positron Emission Mammography), De Paredes says that it's a technology somewhat similar to an MRI in that it's used in a cancer patient to look at the extent of a tumor, but it hasn't been studied by any means to the degree that MRI has.

PEM is believed to be of great value in the preoperative identification of non-invasive breast cancer called Ductal Carcinoma In Situ (DCIS), which is often difficult to quantify with mammography and MRI. PEM has been reported to have a 91% sensitivity for DCIS which far exceeds all other imaging modalities.

Another recent nuclear modality which has proven useful as a second step, if the initial mammogram is inconclusive, is Breast-Specific Gamma Imaging (BSGI). A small amount of the radiotracer Technicium Tc 99m, is delivered to a patient.
Due to the higher metabolic activity of cancerous cells, those cells absorb a greater amount of the tracing agent and are revealed as "hot spots." BSGI captures the cellular functioning of the breast tissue, and is particularly useful for patients with dense breasts.

CAD - the radiologist shortage is giving it a boost

Over the past two decades, computeraided detection and diagnosis (CAD) has been developed to help radiologists detect suspicious changes on mammograms, and this has really taken off with the growth of digital mammography.

"CAD is a hot topic," says Hall. "It's the one reimbursable by most insurance
companies. With a shortage of radiologists and most sites wanting two readings, if you don't have enough doctors, the computer can help you look."

Computers can help doctors identify abnormal areas on a mammogram by acting as a second set of "eyes." For traditional mammograms, the film is fed into a machine, which converts the image into a digital signal that is then analyzed by the computer. Alternatively, the technology can be applied to an image captured with digital mammography. The computer then displays the image on a video screen, with markers pointing to areas that the radiologist should check closely.

A recent study, published in the April 2008 American Journal of Roentgenology, confirms that CAD is useful in screening mammography. The study compares a single reading with CAD to double readings of screening mammography studies.
After considering more than 200,000 mammograms, researchers concluded that CAD, compared to double readings, results in lower recall rates, which was the point of contention. CAD enhances the performance of a single reader with only a small
increase in recall rate. A previous New England Journal of Medicine study suggested that increased CAD false positives were evidence of inaccuracy, leading some insurers to consider dropping CAD reimbursement at least temporarily.

The study finds that, compared with a double reading, single-read CAD resulted in a slight increase in sensitivity at a lower recall rate. Double reading increased sensitivity as well as recall rate when compared to a single reading. (The North Carolina radiology group that conducted the study had switched from double reading to a single reading with CAD.)

The larger volume of film-based CAD studies in the newer research may suggest it supersedes the NEJM study. To read more about the AJR study as originally reported in DOTmed Online News, visit dotmed.com/dm5468.

Mobile mammography

Of the 1700-plus systems sold last year in the U.S., Hall says that less than 50 were for mobile units, but that doesn't stop Hologic from offering a digital system designed for mobile transportation units, which help hospitals and facilities that maybe don't have the money or the need for a system full-time.

The mobile digital mammography van operated by Woman's Hospital in Baton Rouge, LA, for instance, performed 5,000 mammograms using Hologic's technology.

In years past, the crew would drive a small van to a remote site, take the analog equipment out of the van, and set it up in the building that would host the screening. With digital, there's no such portability.

Michael Dobbins, President of Mobile Conversions, Inc., which supplies four different mobile vans throughout the U.S. to universities and breast screening centers, saw the need to switch to digital two years ago, despite the challenges the mobile units faced.

"Digital is what is popular now and better diagnostic readings can be made by the doctors. Digital mammography equipment has much more stringent requirements than analog when it goes mobile," Dobbins says. "It has to be environmentally
maintained. The generator has to operate as you go down the road, air conditioning has to operate as you go down the road... more sensitive shock and vibration issues have to be figured out."

Their mobile mammography equipment visits more than 6,000 locations each year. "We're inspired by what we do," Dobbins says. "We are doing the public some good."

DMS Imaging, in partnership with rural hospitals throughout northeast North Dakota and Northwest Minnesota, is bringing full-field digital mammography to women across the region as well.

"The mission of DMS Imaging is to make a difference in the lives of our patients. We believe all people, no matter where you live, deserve access to cutting-edge health services," says Paul Wilson, CEO of DMS Health Group, the parent company of DMS Imaging. "This gives rural facilities the ability to provide its patients with the highest quality care, without having to invest in the purchase of capital equipment. They likely don't have the patient load to justify having the service available every day, but having the service one or two days a week means their patients don't have to travel to a facility that has the technology available. It's a win-win for the patient and the facility."

Money matters

On top of the different clinical capabilities of all this imaging equipment, the capital costs have to be taken into account. For instance, a new MRI will run around $2 million, a breast CT is $700,000, and a mammography system runs $100,000 for analog to around $300,000 for digital.

When it comes to Medicare reimbursements, the numbers look roughly like this: an analog mammogram is around $85, digital mammogram is $125, CAD is $15-$20, ultrasound is less than $100, and MRI is around $1,000.

The refurbished market

Since digital mammography is three times as expensive as film, there are a lot of hospitals and facilities that are looking to refurbished equipment to update their existing equipment. The same can be said for all imaging modalities.

"The refurbished market is good for us," McGinty says. "People are looking for a lower cost entry point in digital and certainly the refurbished market is a way to do it. We probably get 50-60 percent of what the OEM got upfront. In the case of Digitec, you get a 12 month warranty with the system."

Christopher Cone, CEO of Echoserve, a field service company and repair depot for ultrasound equipment and probes, as well as mammography equipment, says he sees a high demand for refurbished digital mammo equipment. "It's difficult to
find equipment on the aftermarket," he says. "I would guess that the vast majority of refurbished mammo equipment sold is still conventional analog."

Krista Kotrla of Block Imaging International, Inc. says the company has seen their mammography sales increase dramatically in 2008. "A large part of our Women's Health business in mammography is done overseas, or in Latin America where the demand for analog is still very high," she says. "Domestically the demand from end users has been digital and that is where the focus has shifted."

The overseas market

Many countries outside of the U.S. are also switching to digital mammography, but some are taking a while to get there. South America and Latin America, for instance, are still using analog.

"The Netherlands and the Scandinavian countries were early adapters [of digital]," Hall says. "If you start looking at other countries in Europe, say at France, Germany, and the UK, because of the way their healthcare systems are set up, they have just gotten approval for buying digital for the whole country. But it will be a multi-year process before digital mammography is dominant in any of those places."

McGinty says that in some countries, like Japan, they are going to computed radiography (CR), which is a step between analog and digital. "It's not as high quality as DR, but it's very good, and we find a lot of people using CR as an entry point."

The future of mammography

In addition to the modalities already discussed, there are some other things that could be making some noise in breast diagnostics in the next 5-10 years.

"I think in terms of imaging the breast, the thing that is coming on the horizon is tomosynthesis, which potentially could become a significant screening tool," De Paredes says. "It's a form of mammography based off of digital mammography."

Digital tomosynthesis takes multiple X-ray pictures of each breast from many angles. The breast is positioned the same way it is in a conventional mammogram, but only a little pressure is applied-just enough to keep the breast in a stable position during the procedure. The X-ray tube moves in an arc around the breast while 11 images are taken during a seven-second examination. Then the information is sent to a computer, where it is assembled to produce clear, highly focused three-dimensional images throughout the breast.

According to Schroeder, this is very similar to breast CT. "Both use X-ray to create a three-dimensional set of slices of the breast tissue. They are very similar in theory but each may have pros and cons versus the other," he says. "Tomosynthesis is more similar to a conventional mammogram so the transition could be easier to integrate into current centers. However, tomosynthesis may have some challenges to overcome since it uses only a portion of the three dimensional information available to CT scanners. Both modalities will need to be developed with attention to limiting radiation doses."

"GE has done much of the pioneering work in making digital mammography the new standard and is a leader in the race to bring tomosynthesis to market," Schroeder says. "Even as digital mammography is ultimately replaced by a new tool, whatever that may be, it was a necessary step in the evolution of breast cancer screening."

"I think tomosynthesis has a lot of potential," De Parades says. "There are a number of facilities testing it, but it is not FDA approved yet, so it's still in the investigational stage."

Researchers believe that this new breast imaging technique will make breast cancers easier to see in dense breast tissue, and will make breast screening more comfortable.

"What all these improvements in imaging really do is to refine image," Schmitt says, "but once you see something, you're already in trouble. In the ideal future, the goal will be to find it without imaging. What you want to do is find it before it turns into cancer. Whether that can be done through blood testing or some other type of testing, I don't know. What you want to do is predict and interdict the cancer, to stop it before it starts, because once you can image it, it's too late."

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DOTmed Registered Mammography Equipment Sales and Service Companies
Names in boldface are Premium Listings.

Domestic
Christopher Cone, Echoserve, CO
Christine Holland, Parker Medical, Inc., CT
David Denholtz, Integrity Medical Systems, Inc., FL
DOTmed Certified
Dennis Giuzio, Mobile Radiology, Inc., FL
Bob Serros, Amber Diagnostics, Inc., FL
James McGinty, Digitec, Inc., GA
Lars Malmberg, Control Research, Inc., IL
Davyn McGuire, Med Exchange International, Inc., MA
DOTmed Certified
Krista Kotrla, Block Imaging International, Inc., MI
Mark Samii, DMS Health Group, ND
Robert Manetta, Nationwide Imaging Services, Inc., NJ
DOTmed Certified/100
Joseph Jenkins, International Imaging Ltd., NV
Marc Todd, Longevity, LLC, NY
DOTmed Certified
Sal Aidone, Deccaid Services Inc., NY
DOTmed Certified
Mudi Ramesh, Anamika Medical, NY
DOTmed Certified
Leon Gugel, Metropolis International, NY
DOTmed Certified/100
John Kollegger, Bay Shore Medical, LLC, NY
DOTmed 100
Abe Sokol, Absolute Medical Equipment, NY
DOTmed Certified/100
Michael Dobbins, Mobile Conversions, Inc., OH
Jim Monro, RSTI Training Center, OH
DOTmed Certified/100
Tim Austin, Austin's X-Ray Service, OH
William Hengemuhle, IMCO LTD. INC., SC
Jason Botko, A+ Medical Company, Inc., SC
DOTmed Certified/100
Chris Hogan, MEPS Inc., TN

International
David Lapenat, ANDA Medical, Canada
DOTmed Certified
Gautam Sehgal, Ads diagnostic limited, India
DOTmed 100
Cem Tombak, BBTEK Ltd., Turkey

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