Published literature has shown improved early detection of breast cancer when ultrasound is used in addition to mammography. If the SOMO•INSIGHT Clinical Study further demostrates that success, it will be a major benefit in breast cancer screening.

Mary Kay Peterson, MD
Radiologist
Radiology Regional Center
Fort Myers, FL

INSIGHT | Through Participation

There are 11 clinical sites in the US currently recruiting volunteers. You could make a difference in the lives of all women who are screened for breast cancer!

STUDY SUMMARY

This is a study to determine if having a somo•v™ Automated Breast Ultrasound System (ABUS) exam, together with your routine screening mammogram is more sensitive to detecting breast cancer than having a routine screening mammogram without ABUS, if you have dense breast tissue. Potential study volunteers will be recruited at participating breast centers from the group of women who are scheduled to undergo routine screening mammography and who have no breast symptoms or concerns.

A woman's breast density is known to interfere with the early detection of breast cancers because breast density can make breast cancer difficult for a radiologist to see on a screening mammogram. ABUS is a breast imaging technology which is less affected by a woman's breast density, and is currently FDA cleared for use by doctors and sonographers as an adjunct to mammography. ABUS is most commonly used in the diagnostic setting, when a woman has a known breast abnormality or symptom.

The purpose of this study is to determine if ABUS could be a clinically beneficial part of routine breast screening in women who do not have any known abnormalities or symptoms, but do have dense breast tissue which could impact the accuracy of their yearly mammograms. Unlike mammography, ABUS does not use radiation. ABUS uses sound waves at a safe frequency to create detailed three-dimensional pictures of the internal breast tissue. Ultrasound has been shown to find cancer not visible with mammography in women with dense breasts.¹²³ This study will determine if ABUS can help detect small cancers hidden in dense tissue.

About 50,000 women will be considered nationwide for participation in this study. Of these women, only those who have > 50% dense breast tissue will be invited to participate. Volunteers, who provide informed consent and also meet additional inclusion criteria will join the study if they are able to receive an ABUS exam within seven days of their routine screening mammogram at the same clinical site which performed their mammogram. More than 20,000 women will be enrolled nationwide. The results of the mammogram and ABUS screening will be recorded and followed for up to one year. Study participation will be finished at the completion of the next annual routine mammogram, one year after enrollment. If a patient is diagnosed with breast cancer during the 12 month study, participation is completed at the time of diagnosis.

Citation 1: Berg, et al, JAMA 2008; 299(18): 2151-2163
Citation 2: Crystal, et al, AJR 2003; 181: 177-182
Citation 3: Kolb, et al, Radiology 1998; 207(1): 191-199

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WHAT ARE THE STUDY PARTICIPATION REQUIREMENTS?

To participate in this study, you must have a routine screening mammogram at one of our participating study sites and based on that mammogram your breast density must be determined to be > 50% by a study doctor (radiologist).

Volunteers who decide to participate in this study must also agree to the following:

To read the entire consent form, ask for help from a study coordinator or doctor if you do not understand or have questions about the study procedures or requirements, as well as sign the consent form in the presence of a designated study staff member.
To have an Automated Breast Ultrasound (ABUS), if your screening mammogram shows you have dense breast tissue, you meet the other study requirements, you agree to participate in the study and you sign the consent form.
To complete an annual routine mammogram one year after enrollment in the study, at the same clinical site, if the results of the mammogram and ABUS are both normal.
To complete all routine standard care that is recommended by the radiologist (study doctor), which may include diagnostic procedures like additional imaging or a biopsy if there is an abnormality seen on the mammogram or on the ABUS.
To notify the study doctor if any new breast changes or symptoms develop in the year following enrollment.
To be contacted by the study doctor, or one of the study staff members, if the recommended follow-up procedures are incomplete or you do not return to the clinic in one year for an annual routine screening mammogram.
To complete a Study Participant Questionnaire and allow the study doctor to collect the following information from the medical records: breast health history, cancer treatment history, mammogram results, ABUS results, results of biopsy or aspiration, diagnosis and the outcome of follow-up mammogram one year later. Information, like name, date of birth and medical record number will be removed by the study doctor and/or clinic staff before these data are reported and analyzed.

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DO YOU MEET THE PRE-SCREENING CRITERIA? TAKE A QUIZ TO FIND OUT.

Screening to determine eligibility for enrollment will be open to women of all races and ethnicities who are asymptomatic for breast cancer and scheduled for routine screening mammography at the study site. This quiz is for your informational purposes only and does not guarantee eligibility, nor does it promise inclusion in the research study. Only an authorized Study Coordinator or Investigator may perform an official assessment of your qualifications and confirm your eligibility for enrollment in the research study. Additional requirements, which are not included in this quiz, must be evaluated by the clinical study staff at the time of your visit.

Please answer the following questions truthfully and to the best of your knowledge. Your submission is strictly confidential and will not be recorded.

Are you Female?
Yes No

Are you at least 25 years of age?
Yes No

Are you currently experiencing any changes or symptoms in your breasts, including but not limited to lumps, nipple discharge, skin thickening, skin dimpling, shape or symmetry?
Yes No

Are you currently pregnant or breastfeeding?
Yes No

Are you planning to become pregnant in the next 18 months?
Yes No

Have you had any breast surgeries or procedures, such as a biopsy, cyst aspiration, lumpectomy, breast implants or mastectomy in the past 12 months?
Yes No

Have you been diagnosed with any kind of cancer or received any cancer treatment (radiation or chemotherapy) in the past 12 months?
Yes No

Are you willing to return to the clinical site next year to complete your annual screening mammogram?
Yes No

If the study doctor finds an abnormality on your mammogram or ABUS, are you willing to complete the recommended tests, which may include additional imaging or a biopsy?
Yes No

During the next 12 months, would you be willing to contact the study site if you developed any new breast changes or symptoms?
Yes No

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WHAT YOU SHOULD KNOW BEFORE YOU DECIDE TO PARTICIPATE

The sponsor, U-Systems, Inc., will pay for this research study and provide funding to the study doctor for performing the ABUS exam, interpreting the ABUS exam as well as hiring staff members to perform study related activities such as recruiting participants, obtaining informed consent, performing eligibility assessments, managing the study records and entering the anonymous study data into the database. You will not be charged for the ABUS exam or the study doctor's interpretation of the ABUS exam and neither will your insurance company.

All study participants will be helping the research team to evaluate a specific use for the FDA cleared ABUS system: screening women with dense breasts. If ABUS is proven to improve early breast cancer detection rates in women with dense breast tissue, the standard of care for breast screening may change so that all women with dense breast tissue may receive ABUS as part of standard care in addition to screening mammography, and will reduce the number of women who die from breast cancer every year. If no improvement in breast cancer detection is proven, the standard of care will not change and future patients and doctors will benefit from the knowledge that routine screening mammography is the most effective program for early breast cancer detection.

There is no guarantee that participants will receive any direct benefit from being in this study. There is a possibility that ABUS may be better in detecting early breast cancer than mammogram or physical examination alone. Early detection of breast cancer may lead to more effective treatments in the future.

Participating in this study will take approximately 30 to 45 minutes in addition to the time you would normally spend in the office. This time will be spent learning about the research study, completing a Participant Questionnaire, providing informed consent and receiving an ABUS exam. In order for the study doctors to gather data on the accuracy of mammography and ABUS, they will need to collect the mammography and ABUS results, as well as results from any other breast evaluations, procedures or testing performed for the next year, until the completion of an annual routine mammogram, the results of which will also be recorded.

Women who are pregnant or nursing a child may not take part in this study. Women who become pregnant during the duration of the study will be withdrawn because they will not be able to complete the study with an annual mammogram while they are still pregnant or breastfeeding.

Participants will not be reimbursed for their time in participating in this study and they will not receive any payment for participating in the study. This study presents subjects with the opportunity to receive ABUS at no additional cost to them or their insurance when they would otherwise not be entitled to this benefit. Currently, ABUS is FDA cleared as an adjunct to mammography and is most commonly used in women who have known breast abnormalities; those women are not eligible for the study. Women who choose not to participate in the study, and women who are not eligible for the study, will not receive a screening ABUS exam at no cost to them or their insurance.

The sponsor, U-Systems, Inc., will not pay for any standard medical care required as part of your routine breast screening or any complications that occur during participation in this research study. It is possible that the ABUS scan might lead to further medical evaluations, like a diagnostic ultrasound or a biopsy, even if the mammogram is determined by the study doctor to be normal. Your insurance provider will be billed the usual charge for all routine and diagnostic medical evaluations which result from your breast screening and are the standard of care for the particular finding or complication. Depending on your contracted benefits, your health insurance company may or may not pay for these charges. You will be billed for any charges your insurance company does not pay.

There are no known, harmful effects of breast ultrasound, although the procedure itself may be uncomfortable for women with breasts which are tender or sensitive to gentle pressure. If an abnormality is seen on the ABUS examination or on the mammogram, the study doctor may recommend additional tests, which are the standard of care and might include a biopsy. If any potential abnormalities are observed from the ABUS that are not seen on the standard mammogram, the participant and the study doctor will be informed and any testing that may be ordered as a result of the abnormal ABUS will be the same standard tests that would be ordered for an abnormal mammogram.

Other risks of participating in the study include:

Unknown Risks - There may be risks or side effects which are unknown at this time and participation in the study may involve additional risks that are currently unknown.

Loss of confidentiality - Just as with other medical information from routine medical care, all study related information will be kept as confidential as possible. Study information will be kept in locked files and in databases with password protected access. Participant names and any other identifying information will not be released from the clinic and it will not be used in any published reports about this study. There is a need to share protected health information with the study staff at the clinic and because of this, absolute confidentiality cannot be guaranteed.

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