Medical Device Daily

A new clinical study will examine whether full-field mammography along with U-Systems' (San Jose, California) somo•v Automated Breast Ultrasound can improve breast cancer detection when compared to mammography alone in women with dense breasts.

Along with U-Systems Rachel Brem, MD, professor of Radiology, Director, Breast Imaging and Interventional Center, The George Washington University Medical Faculty Associates (Washington) will hold the trial. The company reported that the first patients have already been admitted.

Typically, screening mammography – which is called the standard for breast cancer detection – is limited in detecting breast cancer in women with dense breasts. These women often have a higher risk of breast cancer.

Dense breasts are defined as those with a large proportion of ductal and connective tissue. Regardless of size or shape, dense breasts have a substantially higher risk of developing breast cancer than women whose breasts are classified on a mammogram as "fatty." A woman's breast density can change through life due to age, hormones and menopause.

According to the company, what isn't as widely known is the additional risk women with dense breast tissue have for breast cancer – up to 5-6 times greater than women without dense breast tissue. About 40% of women in the U.S. have some amount of dense breast tissue, and – despite the proven benefits of mammograph – visualization of cancers in dense breast tissue with mammography is limited. The result is missed cancers or the discovery of later-stage cancers in women with dense breast tissue.

The mission of the SOMO INSIGHT clinical trial is to significantly impact the survival rate of women with dense breast cells whose cancer is not visible with mammography 40% of the time. U-Systems is prepping SOMO INSIGHT to determine if having 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 company said that a new approach is needed to improve breast cancer detection for women who undergo mammography with heavy breast density.

"Our objective is to get more than 20,000 women enrolled," Kathy Quiroz, RN, RDMS, Director of Clinical Programs at U-Systems, told Medical Device Daily.

She said that ultimately the company was seeking to have nine different sites and the study would be conducted throughout the next two years.

ABUS is a breast imaging technology that is less affected by a woman's breast density – providing a clearer and more insightful image of a breast with dense tissue.

"Trying to use a mammogram to detect breast cancer in a dense breast ... is like trying to look for a white cloud in a sky full of white clouds," Quiroz said speaking of the difference between the two procedures.

Unlike mammography, which uses radiation, ABUS uses sound waves to create pictures of the internal breast tissue. ABUS was FDA approved back in 2005 for use by doctors and sonographers in the diagnostic setting, when a woman has a known breast abnormality or symptom – but there is not a screening indication for the device to determine if the patient has an abnormality.

When it comes to the actual procedure of screening with the device, there are no plates that compress, no awkward positioning, and, of course, no radiation, the company said.

The technologist applies a layer of lightly scented lotion to the breast, which helps to make the 3-D picture of the inside of it. The sheer membrane of the somo•v ultrasound scanner is carefully positioned on the breast, and the technologist presses a button to begin the scanning process, which lasts about 60 seconds. The technologist will take three scans of each breast: the front side, outer side and inner side. The somo•v exam normally takes less than 15 minutes from the time a patient walks in the room.

Brem, principal investigator for the SOMO INSIGHT clinical study said, "The initiation of the SOMO INSIGHT clinical study is an important step forward in instituting new approaches for the improved early detection of breast cancer. This is especially exciting as the somo•v Automated Breast Ultrasound is a quick test that uses no radiation and has the potential to significantly improve breast cancer detection. This study allows us to bring cutting edge technology to our patients. It is an honor to be leading this study."

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