The movement toward enhanced breast screening for women with dense breast tissue is gaining momentum. Today's blog is meant to help these women advocate for a specific supplemental
screening option: automated breast ultrasound. We'll focus on the somo-v ABUS system from U-Systems. I'll use a Q&A format.
First, how does Automated Breast Ultrasound (ABUS) differ from regular ultrasound?
Both
use sound waves to detect abnormal structures in the breast that
could be tumors. With plain vanilla ultrasound (hand-held ultrasound, or HHUS)
either a radiologist or a highly-trained technician called a
sonographer moves a kind of wand ("transducer") over the surface of the
breast. Think of the wand like a flashlight. As the she moves the wand,
she looks at the image on a monitor in real-time, trying to see possible
tumors. Images can also be captured for later viewing. With ABUS are
that a much larger transducer is configured over the breast (it
isn't manually moved over the breast), automatically taking different
ultrasound images from different angles. These are then processed by a
computer to construct a 3-D image.
What are the main advantages of ABUS?
First,
the 3-D image gives a more complete picture of the entire breast than
HHUS. Second, the images can be compared from year to year, or between
visits, so any changes in the breast are easier to detect. Finally, the method doesn't require a diagnostic medical sonographer to perform. The imaging is automated, similar to mammography. So you don;t have to worry about whether or not the technician might be less experienced. Most ultrasound sonographers are trained and accredited. But their level of experience can also matter with HHUS.
What systems are out there?
The main system on the market is called (and this is a mouthful...) the somo-v INSIGHT Automated Breast Ultrasound (ABUS) system.
It was developed by U-Systems, a Silicon Valley company that
pioneered the field. A similar competing system called the ACUSON S2000 Automated Breast Volume Scanner (ABVS) is marketed by the large German company Seimens AG.
Can Automated Breast Ultrasound be used for screening?
The simple answer is "Yes, and it increasingly is." But realize that breast ultrasound, automated or not, is usually
performed as a diagnostic procedure to further characterize a suspicious
mammogram or MRI result. It's also commonly used to help surgeons guide needles when they perform biopsies. Ultrasound is not traditionally used for screening to assess women with
no suspicion of disease. However, given the growing concerns about mammography and women with dense breast tissue, ultrasound
is increasingly used as a second, supplemental screening
method for that subgroup of women. Generally, screening methods need to be
more automated and require less technical skill than diagnostic methods,
simply because more tests have to be performed more rapidly. This is part of the appeal of the ABUS system. But read on...
Is ABUS approved as a screening method in the US?
No. It's approved for diagnosis, but not for screening. That doesn't keep physicians from using it as a screening method. It does keep U-Systems from marketing it for screening. U-systems is conducting a very large study (20,000 women with dense breasts) in the United States to gain approval for screening. The study is looking at whether screening with mammography plus ABUS outperforms mammography alone. Here we're talking about traditional 2-D mammography and not 3-D mammography (tomosynthesis). Enrollment continues, but the company already feels the data are strong and so they submitted an application to the FDA in April 2011. They added to the data a few weeks ago. The FDA could decide any day now.
Is ABUS approved as a screening method outside the US?
Yes, in Canada and in Europe. It was approved as a screening method by the Canadian regulatory agency Health Canada just last month (Aug 2011). Here's the announcement. It was granted European Union marketing approval a year ago (Sept 2010). Here's some info on that.
Is there a way I can see how it works?
The somo-v system was recently featured on Dr. Oz. Their site has three videos of that episode, which is all about supplemental breast screening. Watch all three if you have time. If you just want to see the somo-v system, just watch part 2. Once you get there, you'll see the links to parts 1 and 3. Sorry but they're going to subject you to some commercials...
How much does it cost?
That depends on the facility providing the service, but typically about $250-300.
Will it be covered by insurance?
That also depends on the judgment and policy of the facility you use, but often it's reimbursed.
How can I find a doctor that performs ABUS in my area?
First, you might check to see if you can get access through U-Systems' clinical study. Data from the trial have already been submitted, but they might still be recruiting. Outside of the clinical trial, it might take you a lot of time to call breast centers on your own. I'd probably just call the company (1-866-364-6777). Legally, remember, they can't talk about the system for screening. So just ask where there's a system installed in your area and hold the screening questions for the facility. Let's just call it "don't ask, don't tell!"
Where can I find more information?
Go to the somo-v Automated Breast Ultrasound page on the LATESTBreastCancer.com website. There we list web links to high-quality news articles and medical journal abstracts about every new medical option.
Showing posts with label u-systems. Show all posts
Showing posts with label u-systems. Show all posts
Wednesday, September 28, 2011
Help for Women with Dense Breasts: U-Systems' somo-v Automated Breast Ultrasound (ABUS)
Friday, September 23, 2011
Dense Breast Tissue: Supplemental Screening Methods
For women who know they have dense breast tissue, we wanted to quickly list the screening methods that are currently used to supplement standard 2-D mammography. By clicking any link below you can quickly see the most recent news and medical journal articles on each. To learn more by accessing complete lists of news and journal article links going back 2-3 years, go to LATESTBreastCancer.com and then find that screening method's page.
Breast ultrasound (US)
Ultrasound uses sound waves rather than x-rays (like mammography) to identify structures in the breast that could be tumors. Most ultrasound devices are hand-held. On our breast ultrasound page you'll find every recent news article and medical journal abstract on the use of breast ultrasound for the detection of tumors in dense breast tissue. Advantages of US are that it's relatively inexpensive (usually a few hundred dollars), widely available and doesn't cause discomfort. Hand-held ultrasound, though, requires a skilled practitioner and it will result in more false positives than mammography.
Automated breast ultrasound (ABUS)
The main advantage of automated compared to hand-held ultrasound is that enables a less labor intensive, operator-dependent workflow. The main (only?) system being marketed in the United States is the somo-v INSIGHT by U-Systems (Sunnyvale, CA). It has regulatory clearance as an adjunct to mammography and is seeing more use, particularly in Connecticut and Texas, states that recently passed dense breast tissue laws and that therefore are seeing increased demand for ultrasound screening.
3-D Mammography
Also called breast tomosynthesis and stereo digital mammography (SDM). The only FDA-approved system on the market in the United States is the Selenia Dimensions System by Hologic, Inc. (Bedford, MA). It was approved in February of this year and is becoming more available. In 3-D mammography, an x-ray imager moves around the breast, taking 15 images from different angles (standard mammography takes two images). These 15 images are then assembled using software to create the 3-D depiction. Imaging from different angles decreases the odds that a tumor will be completely hidden by dense breast tissue. I recommend the August 14th news story from the Boston Globe. The link is on LATESTBreastCancer.com's 3-D Mammography page. All links are conveniently listed in reverse chronological order.
Breast MRI
Along with breast ultrasound, breast MRI is the most commonly mentioned supplemental screening method for women with dense breast tissue. MRI uses a strong magnetic field to excite nuclear particles in breast tissue. A contrast agent chemical (gadolinium-DPA) is first injected into the bloodstream. This agent helps visualize areas containing blood vessel networks, which are suggestive of a tumor. MRI is highly sensitive but does generate a high rate of false positives. It is also very expensive ($2000-6000). The most recent news articles and medical journal articles on breast MRI can be found on our Breast MRI page. Among those are articles that discuss its use as a supplemental screening method for women at high risk, including women with dense breast tissue.
Molecular breast imaging (MBI) systems
Molecular breast imaging is "functional" imaging. It looks at metabolic activity in the breast tissue. This makes is complementary to "anatomical" imaging methods like mammography and ultrasound that look at tissue structures. MBI methods include BSGI (Breast-specific gamma imaging) and PEM (Positron emission mammography). Both generate fewer false-positives than breast MRI and so results in fewer unnecessary biopsies. They are also less expensive than MRI. BSGI and PEM are based on the same principle but use different radioactive tracer molecules and imaging systems. In both, the tracer is absorbed by cells throughout the body. Cancer cells, due to their increased rate of metabolic activity, absorb a greater amount than healthy cells and so appear as dark "hot spots" on the image. The major problem with MBI is that it results in greater exposure to radioactivity.
Breast ultrasound (US)
Ultrasound uses sound waves rather than x-rays (like mammography) to identify structures in the breast that could be tumors. Most ultrasound devices are hand-held. On our breast ultrasound page you'll find every recent news article and medical journal abstract on the use of breast ultrasound for the detection of tumors in dense breast tissue. Advantages of US are that it's relatively inexpensive (usually a few hundred dollars), widely available and doesn't cause discomfort. Hand-held ultrasound, though, requires a skilled practitioner and it will result in more false positives than mammography.
Automated breast ultrasound (ABUS)
The main advantage of automated compared to hand-held ultrasound is that enables a less labor intensive, operator-dependent workflow. The main (only?) system being marketed in the United States is the somo-v INSIGHT by U-Systems (Sunnyvale, CA). It has regulatory clearance as an adjunct to mammography and is seeing more use, particularly in Connecticut and Texas, states that recently passed dense breast tissue laws and that therefore are seeing increased demand for ultrasound screening.
3-D Mammography
Also called breast tomosynthesis and stereo digital mammography (SDM). The only FDA-approved system on the market in the United States is the Selenia Dimensions System by Hologic, Inc. (Bedford, MA). It was approved in February of this year and is becoming more available. In 3-D mammography, an x-ray imager moves around the breast, taking 15 images from different angles (standard mammography takes two images). These 15 images are then assembled using software to create the 3-D depiction. Imaging from different angles decreases the odds that a tumor will be completely hidden by dense breast tissue. I recommend the August 14th news story from the Boston Globe. The link is on LATESTBreastCancer.com's 3-D Mammography page. All links are conveniently listed in reverse chronological order.
Breast MRI
Along with breast ultrasound, breast MRI is the most commonly mentioned supplemental screening method for women with dense breast tissue. MRI uses a strong magnetic field to excite nuclear particles in breast tissue. A contrast agent chemical (gadolinium-DPA) is first injected into the bloodstream. This agent helps visualize areas containing blood vessel networks, which are suggestive of a tumor. MRI is highly sensitive but does generate a high rate of false positives. It is also very expensive ($2000-6000). The most recent news articles and medical journal articles on breast MRI can be found on our Breast MRI page. Among those are articles that discuss its use as a supplemental screening method for women at high risk, including women with dense breast tissue.
Molecular breast imaging (MBI) systems
Molecular breast imaging is "functional" imaging. It looks at metabolic activity in the breast tissue. This makes is complementary to "anatomical" imaging methods like mammography and ultrasound that look at tissue structures. MBI methods include BSGI (Breast-specific gamma imaging) and PEM (Positron emission mammography). Both generate fewer false-positives than breast MRI and so results in fewer unnecessary biopsies. They are also less expensive than MRI. BSGI and PEM are based on the same principle but use different radioactive tracer molecules and imaging systems. In both, the tracer is absorbed by cells throughout the body. Cancer cells, due to their increased rate of metabolic activity, absorb a greater amount than healthy cells and so appear as dark "hot spots" on the image. The major problem with MBI is that it results in greater exposure to radioactivity.
Labels:
3-d mammography,
abus,
breast tomosynthesis,
breast-specific gamma imaging,
bsgi,
dense breasts,
hologic,
mri,
pem,
positron emission mammography,
screening,
selenia dimensions,
somo-v,
u-systems
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