FDA approves new technology tool for breast cancer screening

Dec 6 2009

The FDA has approved new technology that now allows radiologists to detect breast cancer sooner and faster. The SonoCine Automated Whole-breast Ultrasound Method and is being offered by only one facility in Arizona - Arizona Breastnet, in Scottsdale. This unique technology is designed specifically as a breast cancer screening tool to enhance yearly mammography screening. Until now, ultrasound has only been used for diagnostic purposes - not for screening for breast cancer.

A new study, published in European Radiology, found that adding the SonoCine automated whole-breast ultrasound exam to the annual mammogram doubled the number of cancers found in a group representing approximately 40% of all women seeking annual mammograms. This contrasts with previous studies which have examined the use of additional tests only on women with significantly elevated risks of developing breast cancer.

Local radiologist, Belinda Barclay-White, MD, is the first physician to offer this technology in Arizona, and has already experienced its powerful capabilities.

According to Dr. Barclay-White, "87% of all breast cancers are found in women who have none of the traditional risk factors, such as family history. There have been many studies done on women with the BRAC1 and BRAC2 breast cancer gene and other risk factors, but not much is being done for relatively normal women for whom the mammogram does not always provide a complete picture."

In women with dense breasts, mammograms are more difficult to interpret because it can be difficult to 'see through' the dense tissue, which appears white on the mammogram. Cancerous lumps also appear white, so they become invisible and difficult to differentiate. The SonoCine Method can detect small cancers because the dense breast tissue appears white while cancerous tissue appears dark. It also takes an ultrasound video of an entire patient's breast exam, instead of just single pictures, so it can be stopped, can be magnified and the radiologist can even go back and forth to be sure nothing is missed.

"It is not a replacement for screening mammography, but an additional exam for women with dense breasts and for some women with breast implants," explains Dr. Barclay-White. "There are relatively few radiologists trained to offer screening ultrasound as part of the breast screening process, even though the advantages are many. It is less expensive than MRI, there are no contrast injections, no radio nuclide injections, no radiation and no breast compression. In experienced hands, we do not have the high false positive biopsy rates we see with MRI. When cancers are found with ultrasound, they are significantly smaller than when they are eventually visible on mammograms, making treatment outcomes very positive."

Since acquiring SonoCine, Breastnet has found two breast cancers. One was not visible on the mammogram or on a recent MRI and was not present on an ultrasound 15 months prior. Barclay-White performed a screening SonoCine UltraSound on the patient and found a 5mm invasive non-palpable ductal carcinoma. "Early detection really does save lives and to find this type of cancer at such a small size is significant when we are talking about patient outcomes," according to Barclay-White.

Patients at Arizona Breastnet, who are candidates for SonoCine UltraSound, are happily adding this screening tool to their yearly mammogram program for added peace of mind, even though it is not covered by insurance. All women should be made aware that it is now available and should check to see if they are candidates for the exam. The cost is $300.