Novel ultrasound device may better detect cancers among women with dense breast tissue

Mary W. Yamashita

A clinical trial is underway to assess the effectiveness of a novel breast ultrasound device for asymptomatic women with dense breast tissue.

SoftVue (Delphinus Medical Technologies) is the first 3-D, whole-breast ultrasound system designed to help physicians distinguish normal breast tissue from cancerous tissue.

“More than 40% of U.S. women have dense breasts and, [although] mammography is the best screening tool for women today, we have known for years that breast cancers are much more difficult to see on the mammogram in women with dense breasts,” Mary W. Yamashita, MD, assistant professor of clinical radiology at Keck School of Medicine of USC, said in a press release. “Our hope is that this technology will enable us to detect cancers much sooner in women with dense breast tissue so that we can provide better outcomes for women with cancer, and peace of mind for women with a normal study.”

HemOnc Today spoke with Yamashita about how SoftVue works, the challenges of breast cancer screening for women with dense breasts, and how this device may overcome those challenges.

 

Question: Can you describe the SoftVue device and how it works?

Answer: SoftVue is a 3-D, fully automated, whole-breast ultrasound system developed to provide detailed images of the breast. It uses the same soundwaves that we use to look at infants in pregnant women. The device scans the breast while the patient lies on a soft, padded table with her breasts in a warm-water bath. A large transducer ring automatically scans the entire breast in a single path, moving from front to back. Each scan takes 2 minutes to 4 minutes per breast. Unlike the mammogram, there is no radiation exposure or compression with the SoftVue device.

 

Q: How will the trial be conducted?

A: The goal of the study is to enroll 10,000 asymptomatic women across the United States with dense breast tissue who are due for their annual screening mammograms. These women will receive both 2-D digital mammogram, 3-D digital breast tomosynthesis and SoftVue exam so we can compare the performance of these different modalities for detecting breast cancer. Ultimately, the information gathered from this clinical trial will determine if additional cancers can be found with SoftVue that cannot be found with mammogram alone. We hope to complete this trial within 1 year.

 

Q: Can you describe the challenges associated with breast cancer screening for women with dense breasts?

A: Cancers are not easily seen on mammograms of women with dense breast tissue. Dense breasts have nothing to do with the size, weight or feel of the breast. Instead, dense breast tissue is a description of how a breast appears on mammogram. Breasts are comprised of both fat and glandular tissue. On a mammogram, fat appears black and glandular tissue appears white. Dense breasts have more glandular tissue, so the background appears white on mammogram. The problem is that cancers also are white on mammogram, so it is more difficult to see a white cancer on a white background, so dense breasts may hide cancers on mammogram. In 2013, California passed a density notification law that requires radiologists to inform patients when their mammograms show dense breasts. These letters inform women with dense breasts that their mammograms may not detect all breast cancers, and they may be at increased risk for developing breast cancer. They are encouraged to talk to their physicians for more information about their risks and additional screening options. To date, 30 states have adopted some form of the breast density notification law.

 

Q: How may SoftVue help overcome these screening challenges?

A: Studies have shown that, in dense breasts, ultrasound can detect tumors that are not seen on mammogram. However, handheld ultrasound primarily is used for diagnostic purposes to evaluate a specific part of the breast. For example, if a woman comes in with a lump or pain, we use handheld ultrasound to evaluate that specific area. Handheld ultrasound is not routinely used as a tool to screen the entire breast. More importantly, the accuracy of handheld ultrasound is largely dependent on the skill of the person performing the ultrasound. In many clinics, a technologist — not a physician — performs the scan. SoftVue is a completely automated ultrasound system that looks at the entire breast. We do not have to rely on a person to recognize the abnormalities and capture the images.

 

Q: Are there other devices on the market or in clinical trials that are comparable to SoftVue ?

A: I am not aware of any similar devices on the market or in clinical trials. SoftVue is the first 3-D, fully automated whole-breast ultrasound system. With traditional handheld ultrasound, there is limited information about the masses found in the breast, and many women undergo unnecessary biopsies for benign masses. On the other hand, SoftVue gives distinctive tissue characterization — reflection, sound speed, attenuation and stiffness — that may potentially help us to characterize masses found in breasts so that we may better differentiate benign findings, such as cysts and fibroadenomas, from cancers. With this technology, we hope to be able to find small cancers not seen on mammograms while avoiding many unnecessary biopsies.

 

Q: Is there anything else that you would like to mention ?

A: The University of Southern California Norris Comprehensive Cancer Center is the national principal site for this clinical trial, and we are thrilled to be leading this study. I also feel fortunate to have been chosen as the national principle investigator. In addition to the University of Southern California, the other clinical trial sites include Mount Sinai Medical Center in Miami, Beaumont Hospital in Dearborn, Mich., SouthCoast Health Imaging in Savannah, Ga., St. Elizabeth Hospital in Appleton, Wisc., Weinstein Imaging in Pittsburgh, and The University of North Carolina at Chapel Hill. We will have to wait on the results of 10,000 women with dense breasts, but I am eager to see if SoftVue will help us find more cancers than mammogram alone. If this is the case, we will be able to offer SoftVue to all women with dense breasts as an adjunctive screening study to mammography for early detection of breast cancer.

Asymptomatic women with dense breasts who are due for their screening mammogram can enroll in this study. More information about SoftVue and the clinical trial is available at www.discoversoftvue.com.

 

For more information:

Mary W. Yamashita, MD, can be reached at Keck School of Medicine of USC, Radiology, NOR 1441 Eastlake Ave. G360, Health Sciences Campus, Los Angeles, CA 90033-0804; email: mary.yamashita@med.usc.edu.

 

Disclosure: Yamashita reports no relevant financial disclosures.

Mary W. Yamashita

A clinical trial is underway to assess the effectiveness of a novel breast ultrasound device for asymptomatic women with dense breast tissue.

SoftVue (Delphinus Medical Technologies) is the first 3-D, whole-breast ultrasound system designed to help physicians distinguish normal breast tissue from cancerous tissue.

“More than 40% of U.S. women have dense breasts and, [although] mammography is the best screening tool for women today, we have known for years that breast cancers are much more difficult to see on the mammogram in women with dense breasts,” Mary W. Yamashita, MD, assistant professor of clinical radiology at Keck School of Medicine of USC, said in a press release. “Our hope is that this technology will enable us to detect cancers much sooner in women with dense breast tissue so that we can provide better outcomes for women with cancer, and peace of mind for women with a normal study.”

HemOnc Today spoke with Yamashita about how SoftVue works, the challenges of breast cancer screening for women with dense breasts, and how this device may overcome those challenges.

 

Question: Can you describe the SoftVue device and how it works?

Answer: SoftVue is a 3-D, fully automated, whole-breast ultrasound system developed to provide detailed images of the breast. It uses the same soundwaves that we use to look at infants in pregnant women. The device scans the breast while the patient lies on a soft, padded table with her breasts in a warm-water bath. A large transducer ring automatically scans the entire breast in a single path, moving from front to back. Each scan takes 2 minutes to 4 minutes per breast. Unlike the mammogram, there is no radiation exposure or compression with the SoftVue device.

 

Q: How will the trial be conducted?

A: The goal of the study is to enroll 10,000 asymptomatic women across the United States with dense breast tissue who are due for their annual screening mammograms. These women will receive both 2-D digital mammogram, 3-D digital breast tomosynthesis and SoftVue exam so we can compare the performance of these different modalities for detecting breast cancer. Ultimately, the information gathered from this clinical trial will determine if additional cancers can be found with SoftVue that cannot be found with mammogram alone. We hope to complete this trial within 1 year.

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Q: Can you describe the challenges associated with breast cancer screening for women with dense breasts?

A: Cancers are not easily seen on mammograms of women with dense breast tissue. Dense breasts have nothing to do with the size, weight or feel of the breast. Instead, dense breast tissue is a description of how a breast appears on mammogram. Breasts are comprised of both fat and glandular tissue. On a mammogram, fat appears black and glandular tissue appears white. Dense breasts have more glandular tissue, so the background appears white on mammogram. The problem is that cancers also are white on mammogram, so it is more difficult to see a white cancer on a white background, so dense breasts may hide cancers on mammogram. In 2013, California passed a density notification law that requires radiologists to inform patients when their mammograms show dense breasts. These letters inform women with dense breasts that their mammograms may not detect all breast cancers, and they may be at increased risk for developing breast cancer. They are encouraged to talk to their physicians for more information about their risks and additional screening options. To date, 30 states have adopted some form of the breast density notification law.

 

Q: How may SoftVue help overcome these screening challenges?

A: Studies have shown that, in dense breasts, ultrasound can detect tumors that are not seen on mammogram. However, handheld ultrasound primarily is used for diagnostic purposes to evaluate a specific part of the breast. For example, if a woman comes in with a lump or pain, we use handheld ultrasound to evaluate that specific area. Handheld ultrasound is not routinely used as a tool to screen the entire breast. More importantly, the accuracy of handheld ultrasound is largely dependent on the skill of the person performing the ultrasound. In many clinics, a technologist — not a physician — performs the scan. SoftVue is a completely automated ultrasound system that looks at the entire breast. We do not have to rely on a person to recognize the abnormalities and capture the images.

 

Q: Are there other devices on the market or in clinical trials that are comparable to SoftVue ?

A: I am not aware of any similar devices on the market or in clinical trials. SoftVue is the first 3-D, fully automated whole-breast ultrasound system. With traditional handheld ultrasound, there is limited information about the masses found in the breast, and many women undergo unnecessary biopsies for benign masses. On the other hand, SoftVue gives distinctive tissue characterization — reflection, sound speed, attenuation and stiffness — that may potentially help us to characterize masses found in breasts so that we may better differentiate benign findings, such as cysts and fibroadenomas, from cancers. With this technology, we hope to be able to find small cancers not seen on mammograms while avoiding many unnecessary biopsies.

PAGE BREAK

 

Q: Is there anything else that you would like to mention ?

A: The University of Southern California Norris Comprehensive Cancer Center is the national principal site for this clinical trial, and we are thrilled to be leading this study. I also feel fortunate to have been chosen as the national principle investigator. In addition to the University of Southern California, the other clinical trial sites include Mount Sinai Medical Center in Miami, Beaumont Hospital in Dearborn, Mich., SouthCoast Health Imaging in Savannah, Ga., St. Elizabeth Hospital in Appleton, Wisc., Weinstein Imaging in Pittsburgh, and The University of North Carolina at Chapel Hill. We will have to wait on the results of 10,000 women with dense breasts, but I am eager to see if SoftVue will help us find more cancers than mammogram alone. If this is the case, we will be able to offer SoftVue to all women with dense breasts as an adjunctive screening study to mammography for early detection of breast cancer.

Asymptomatic women with dense breasts who are due for their screening mammogram can enroll in this study. More information about SoftVue and the clinical trial is available at www.discoversoftvue.com.

 

For more information:

Mary W. Yamashita, MD, can be reached at Keck School of Medicine of USC, Radiology, NOR 1441 Eastlake Ave. G360, Health Sciences Campus, Los Angeles, CA 90033-0804; email: mary.yamashita@med.usc.edu.

 

Disclosure: Yamashita reports no relevant financial disclosures.