Questions & Answers

  • Q: What does it mean to have ‘dense breasts’?
  • A: 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’.
  • Q: How do I know if I have ‘dense breasts’?
  • A: 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.
  • Q: What is the somo•v ABUS (Automated Breast Ultrasound System)?
  • A: 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.
  • Q: Why should I have ABUS performed?
  • A: 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.
  • Q: What will happen during the clinical study?
  • A: 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.
  • Q: How long will I be in the clinical study?
  • A: 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.
  • Q: Are there any benefits to me for participating in the clinical study?
  • A: 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.
  • Q: Are there any risks to me for participating in the clinical study?
  • A: 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.