Norris Center clinical trial helps detect early breast cancer

The USC Norris Comprehensive Cancer Center is taking steps to improve the detection of breast cancer in women through a new clinical trial.

Mary Yamashita is the chief researcher for the clinical trial, which uses ultrasound technology to screen women for breast cancer. Her office is the only site in Southern California for the nationwide clinical trial that uses SoftVue, a 3-D ultrasound system. It is also the first of eight health centers across the United States to test it.

SoftVue takes a comprehensive 3-D image that allows doctors to view four different cross sections for women with dense breast tissue. The trial has a goal of testing 10,000 women, and the results will be submitted to the Food and Drug Administration to approve SoftVue as a supplemental screening indication for breast cancer, according to Yamashita.

Beginning at age 40, women will typically undergo annual mammograms that help detect cancerous lumps. However, mammograms can only read so much, and doctors performing the procedure on women with dense breast tissue have a harder time identifying cancers.

There are no telling markers as to why some women have denser breast tissues than others, Yamashita said. Over 40 percent of adult women have dense breast tissue, with the phenomena occurring more often in younger women.

“When we say dense breast tissue, we’re not talking about how dense the breast feels, but it’s about how it appears on a mammogram,” Yamashita said. “So, if you have dense breast tissue, then that means on a mammogram, your breast looks white. If you have more fatty tissue, then on the mammogram, the breast looks dark. Breast cancer appears white.”

Yamashita identifies this as the crux of the problem facing current technology.

Doctors with patients that have dense breast tissues have a harder time identifying cancer because of the current imaging results. Thus, it is even more difficult to detect breast cancers among these patients.

The clinical trial has been a long time coming for Yamashita, who began working with breast cancer and ultrasound devices nearly 10 years ago when USC was involved in a multi-center ultrasound study.

“When we did that study, we discovered that with ultrasound, when we added it to mammography, we were able to find additional cancers that were not seen on [the] mammogram,” Yamashita said.

The details of Yamashita’s previous study at USC was the preface to the current ultrasound technology trial she is developing at the Norris Comprehensive Cancer Center.

The new ultrasound technology allows for four different cross sections to be viewed. SoftVue provides the standard black and white reflection image, as well as a color transmission image, a sound speed image and stiffness fusion image.

All four images combined create a stronger indicator of whether someone has breast cancer when they also have dense breast tissue. According to Yamashita, cancerous masses have a very specific makeup and are more easily identified once all four images are combined in order to identify masses.

“Different companies have tried to come up with an automated ultrasound system so that you’re not relying on the person scanning,” Yamashita said. “It is more efficient, more accurate but there really is no tool out there right now that is completely automated.”

SoftVue, she said, is different, as it is completely automated and does not need a secondary person there to hold the breast while the transducer creates the image. In addition, it takes only about two to four minutes to take images, as opposed to 20 to 30 minutes for a handheld ultrasound.

Yamashita’s clinical trial, if proven successful, will allow women with dense breast tissue to have a more accurate reading that will hopefully allow for earlier and better detection of cancerous lumps.