• What is the SOMO•INSIGHT Breast Cancer Screening Study?
  
• What is the Clinical Problem?
  
• What is Breast Density and what does it mean?
  
• What is somo•v Automated Breast Ultrasound?
  
• Questions & Answers
  

What is the SOMO•INSIGHT Breast Cancer Screening Study?

SOMO•INSIGHT is a multi-center nationwide clinical research study sponsored by U-Systems, Inc. to evaluate if the somo•v™ Automated Breast Ultrasound (ABUS) done together with a routine screening mammogram (x-ray) is more accurate in detecting breast cancer in women with dense breast tissue than having a routine screening mammogram alone. The fully automated ultrasound technology, which is used in the clinical research study is cost effective and patient friendly. The somo•VIEWer™ software creates 3D-reconstructed images of the breast tissue for the radiologist to review.

You can help!
Be a part of a groundbreaking clinical research study that may help women get more thorough breast cancer screenings. The SOMO•INSIGHT study will help determine if using a 3D ultrasound imaging technology in combination with a mammogram could improve the accuracy of routine screenings for women with dense breast tissue. Breast cancer awareness has come a long way in the past few years, and the need for yearly screening is a message that's thankfully spreading to save lives.

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What is the Clinical Problem?

In 2009, an estimated 192,370 new cases of invasive breast cancer will be diagnosed in women in the United States, as well as an estimated 62,280 additional cases of in situ breast cancer. In 2009 about 41,000 will die from this devastating disease, secondary only to lung and bronchus cancer in frequency and cancer deaths in women. ¹ Survival rates in women with breast cancer are much higher when the cancer is detected at an early stage and this is why routine screening mammograms are recommended by the American Cancer Society for women 40 years of age and older.^1,2

Screening mammography has long been the mainstay in detecting non-palpable breast cancer while it is the most curable. However, while the accuracy of mammography is high in fatty breasts, breast density is a major limitation to the sensitivity of mammographic screening, prompting researchers to look for alternative methods to improve detection in these women. Breast density is a strong independent risk factor for the development of breast cancer. In several studies, women with the highest levels of breast density were found to have a 4- to 6-fold increased risk of breast cancer compared with women with the lowest density classification .³

Breast density has also been shown to increase a women's lifetime risk for developing breast cancer. About 40% of women have some dense breast tissue, and visualization of cancers in dense breast tissue with mammography is sometimes limited.^1,3,4,5 The result is missed cancers or the discovery of later-stage cancers in women which may require more aggressive treatment options.²  A more thorough screening approach may be needed for these women and the SOMO•INSIGHT clinical research study is exploring a possible solution. 

According to a peer reviewed study by Boyd et al published in the New England Journal of Medicine, "Women with dense tissue in 75% or more of the breast have a risk of breast cancer four to six times as great as the risk among women with little or no dense tissue."³ While mammography remains the gold standard for breast cancer screening, clinical studies have shown improved early detection of breast cancer when ultrasound is used as an adjunct to mammography for women with dense breast tissue.

Citation 1: American Cancer Society. Breast Cancer Facts & Figures 2007-2010
Citation 2: Duffy SW, Tabár L, et al. Cancer. 2002;458-469
Citation 3: Boyd, et al. New England Journal of Medicine 2007;356:227-36M
Citation 4: Stone, et al. Cancer Epidemiology, Biomarkers & Prevention. 2006;612-617
Citation 5: Kolb, et al. Radiology. 1998;191-199

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What is Breast Density and what does it mean?

Breast density is a way to describe the types of tissue that make up the breast. The breast is made up of glandular or ductal tissue, fibrous connective tissue and fatty tissue.  The amount of each of these tissues varies in women. Women who have more fibrous connective and glandular tissue than fatty tissue have more breast density

Mammogram of BIRADS III Heterogeneously Dense Breasts

A woman's breast density can change through life due to age, hormones and menopause.
Regardless of size or shape, dense breasts have a substantially higher risk of breast cancer than women whose breasts are classified as "fatty". Breast density can make breast cancer difficult for a radiologist to see on a mammogram.  

Breast Density: How do you know?
Only your doctor can determine your individual breast density from a mammogram.

What's your BIRADS?
Breast density is classified using the BIRADS (American College of Radiology Breast Imaging Reporting and Data System) scoring method. This method describes four different categories:

BIRADS I - Entirely fat
BIRADS II - Scattered fibroglandular densities
BIRADS III - Heterogeneously dense
BIRADS IV - Extremely dense

Ask your doctor; every woman should know her BIRADS breast density class.

Using U-Systems software, the radiologist can look through hundreds of breast tissue image "slices" virtually peeling back the layers of dense tissue to visualize cancers, which may have been hidden by that tissue on the mammogram.

A single Coronal slice from an ABUS exam.The nipple is marked in yellow.

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What is somo•v Automated Breast Ultrasound?

The somo•v Automated Breast Ultrasound System (ABUS) is an ultrasound breast imaging technology that is less affected by a woman's breast density - providing a clearer and more INSIGHTful image. Unlike mammography, which uses radiation, ABUS uses sound waves to create 3D images of the breast tissue. The ABUS ultrasound device is FDA cleared for use by doctors in combination with mammography to diagnose breast lesions, and is most commonly used when a woman has known breast abnormality or symptom. ABUS is currently under evaluation to see if it can be used in combination with mammography to screen asymptomatic women with dense breasts.

The ABUS Screening Experience

From the moment you lie down on the padded exam table, you'll realize that receiving a  ABUS screening is completely unlike a mammogram experience. A layer of lightly scented ultrasound lotion is applied, which helps to make the 3D picture of your breast. To ensure the best image quality, the sheer membrane of the somo•v is firmly positioned on your breast. The technologist presses a button to begin the scanning process, which lasts about 60 seconds.  

Most women report the procedure to be comfortable, but some women with very sensitive breast tissue have described the procedure to be uncomfortable.  Always inform the technologist of your comfort level during the scanning process.  The technologist will take three scans of each breast: the front, outer and inner sides.

The somo•v exam takes less than 15 minutes from the time you walk in the room, providing your doctor with a state-of-the-art 3D ultrasound of the inside of your breasts regardless of your breast density class. 

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Questions & Answers

What does it mean to have 'dense breasts'?
Breast density is a way to describe the types of tissue that make up the breast. The breast is made up of glandular tissue, fibrous connective tissue and fatty tissue. The amount of each of these tissues varies from one woman to another. Women who have more fibrous connective and glandular tissue than fatty tissue have more breast density. Regardless of size or shape, dense breasts have a substantially higher risk of breast cancer than women whose breasts are classified as 'fatty'.

How do I know if I have 'dense breasts'?
This information can only be obtained from your doctor. From a screening mammogram your doctor can determine your individual breast density. Ask your doctor; every woman should know her breast density class.

What is the somo•v ABUS (Automated Breast Ultrasound System)?
The somo•v ABUS is an ultrasound breast imaging technology that is less affected by a woman's breast density - providing a clearer and more INSIGHTful image using sound waves to create 3D pictures of the breast tissue. The ultrasound device is FDA cleared for use by doctors in combination with mammography. This device is under evaluation for the purpose of screening women with dense breasts in combination with mammography. Eligible participants who are enrolled in this study will receive an ABUS exam at no cost to them or their insurance.

Why should I have ABUS performed?
Breast cancer is one of the most commonly found cancers in American women. Breast density can make breast cancer difficult for a radiologist to see on a mammogram. Research has shown that women who have dense breast tissue may have an increased risk of developing breast cancer in their lifetime than women who do not have dense breast tissue.

What will happen during the clinical study?
You will continue to have all the routine standard care that is recommended by the study doctor. If you agree to volunteer and you meet the eligibility requirements, you will need to complete a patient questionnaire and sign a Consent Form. You will have a 3D Automated Breast Ultrasound (ABUS) exam on both of your breasts, if your mammogram shows that you have dense breasts. The somo•v ABUS procedure requires an additional 15 minutes of your time. The physician will review the ABUS images, and may recommend follow-up treatment or evaluation procedures to evaluate areas seen on the ABUS images.

How long will I be in the clinical study?
Your participation is for 1 year. This includes the initial somo•v ABUS procedure and an appointment in twelve months for your next screening mammogram. In order for the study doctors to gather data on the accuracy of mammography and ABUS, they will need to have the results from your current mammogram and ABUS as well as the results of your next screening mammogram 12 months later.

Are there any benefits to me for participating in the clinical study?
There is no guarantee that you will receive any direct benefit from being in this clinical study. There is a potential that the 3D ABUS may visualize a breast lesion not seen on mammogram or physical examination alone, especially if you have dense breasts. Studies have shown that early detection of breast cancer may lead to more effective treatment.¹ If you meet the requirements and sign the Consent Form, ABUS will be performed at no extra cost to you or your insurance.

Are there any risks to me for participating in the clinical study?
Once the physician reviews the ABUS images, he/she may recommend follow-up treatment or evaluation procedures to evaluate the lesions seen on the ABUS images. This may require an additional appointment, diagnostic ultrasound, or other procedures to evaluate the lesion identified.

Citation 1: Duffy SW; Tabár L, et al. Cancer. 2002;458-469

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