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Women who have no signs or symptoms of breast cancer who have \> 50% parenchymal density on mammography.

After density \> 50% is confirmed by routine digital screening mammography, ABUS will be performed.

Automated Breast Ultrasound (ABUS) as an adjunct to digital screening mammography

Rachel F Brem, MD

Hypothesis: A higher sensitivity to breast cancer detection can be achieved in women with dense breast tissue by performing and reviewing results of Automated Breast Ultrasound (ABUS) and Digital X-Ray Mammography (XRM) together as part of routine screening compared to performing and reviewing results of XRM alone.

Primary Objective: For the cohort of asymptomatic women who have dense breast tissue, calculate the sensitivity of Digital X-Ray Mammography (XRM) and ABUS together as a breast cancer screening modality and compare it to that of XRM alone.

Secondary Objective: For the cohort of asymptomatic women who have dense breast tissue, evaluate the specificity of XRM and ABUS together compared to that of XRM alone; Calculate the negative predictive value (NPV) and positive predictive value (PPV) for XRM and ABUS.

Endpoint: Breast cancers detected by radiologists in the clinical screening setting and confirmed by pathology.

Study Design: This is a prospective matched-pair clinical study enrolling more than 20,000 women with parenchymal density \> 50% on digital x-ray mammography (XRM). Participants will receive ABUS as an adjunct to XRM. Any abnormal findings, from either XRM or ABUS, will receive appropriate management action consistent with accepted medical standards of care. All evaluation results, diagnosis and treatment outcomes will be recorded. Participants will be followed for one year and those who are not diagnosed with breast cancer at enrollment or during the follow-up interval must undergo an annual mammogram at study completion, the outcome of which will be recorded.

This is a study to determine if having somo٠v™ (U-Systems, Inc.) Automated Breast Ultrasound (ABUS) done together with a routine screening mammogram, is more sensitive to detecting breast cancer in women with dense breast tissue than getting a routine screening mammogram without ABUS. Potential study volunteers will be recruited at participating breast centers from the cohort of asymptomatic women who are scheduled to undergo routine screening mammography.

Breast cancer is one of the most commonly diagnosed cancers in American women with an estimated 210,000 new cases diagnosed in 2007. Death rates in women with breast cancer are much lower when the cancer is detected at an early stage, and less intense forms of treatment can be used at early stages when cancerous lesions are the smallest. It is for this reason that annual routine mammograms are recommended by the American Cancer Society for women 40 years of age and older and are the current standard of care for breast cancer screening.

One thing that is known to interfere with the early detection of breast cancer with mammograms is a woman's breast density. Women under age 50 tend to have more density in their breasts than women who are older, but density may be present in women of all ages and is estimated to exist in 40% to 60% of all women who have mammograms. Women who have more fibrous connective and glandular tissue than fatty tissue in their breasts have more breast density.

Breast density can make breast cancer difficult for a radiologist to see on a mammogram. Also, research has shown that women who have dense breast tissue are more likely to develop breast cancer in their lifetime than women who do not have dense breast tissue. Automated Breast Ultrasound (ABUS) is a breast imaging technology which is less affected by a woman's breast density, and is currently FDA approved 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.

This study will try to determine if ABUS can be a clinically beneficial element 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 pictures of the internal breast tissue. Ultrasound has been shown to find cancer not visible with mammography in women with dense breasts. The ABUS used in this study automatically scans the breast and may help detect cancers in dense tissue.

All women who volunteer to participate in this study and who also meet the study requirements will receive ABUS in addition to their routine screening mammogram. The outcome of this 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, or the diagnosis of breast cancer, whichever comes first.

More than 50,000 women will be invited nationwide to provide informed consent and be screened for eligibility to participate. More than 20,000 women will meet the primary inclusion requirement of having \> 50% dense breast tissue and will be enrolled in this study.

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

1. To have all routine standard care that is recommended by the study doctor, which may include diagnostic procedures like additional imaging or a biopsy, OR, if the results of screening (ABUS and XRM) are negative (normal or benign), agree to complete an annual routine screening mammogram one year from now and notify the study doctor if any breast changes or symptoms develop during this year.
2. To be contacted by the study doctor, or one of the study staff members, if the recommended follow-up procedures are incomplete or if the volunteer does not return to the clinic in one year for an annual routine screening mammogram.
3. To have an Automated Breast Ultrasound (ABUS), if the screening mammogram indicates dense breast tissue. ABUS will require the patient to lay comfortably on her back for approximately 10 minutes while the ultrasound is being performed. The study includes as many as three ultrasound scans of each breast, each scan lasting one minute. Unlike a mammogram, ABUS does not involve any mammography-like compression. Instead, the breast will be lightly pressed against the patient's body during the scan. If the mammogram shows that the breast tissue is not dense, the volunteer will not be eligible for further participation in the study and will not undergo an ABUS. The participant will still receive the same standard care and treatment she would normally receive.
4. 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.

Participating in this study will take approximately 30 minutes in addition to the time a participant would normally spend in the office. This time will be spent learning about the study, providing informed consent and receiving ABUS. 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.

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:

1. 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.
2. 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.

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.

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.

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 approved 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.

All study participants will be helping us evaluate a specific use for the FDA approved 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 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.

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.

The sponsor, U-Systems, Inc., will pay for this research study and provide funding to the study doctor for study related procedures and management of the study records.

A Clinical Study to Evaluate Somo•v and Digital Mammography Together as a Breast Cancer Screening Method, Compared to Digital Mammography Alone, in Women With Dense Breasts.

A Prospective Multicenter Matched-pair Clinical Study to Evaluate the Sensitivity and Specificity of ABUS and Digital X-Ray Mammography (XRM) Together as a Breast Cancer Screening Method Compared to XRM Alone in Women With >50% Parenchymal Density.

U-Systems, Inc.

Automated Breast Ultrasound (ABUS) as an adjunct to digital screening mammography.

Automated Breast Ultrasound (ABUS)

Maryellen Giger, Ph.D.

To determine the impact on Interpreting Physician performance in detecting breast cancer, as defined by the area under the Receiver Operating Characteristic Curve (ROC), when Automated Breast Ultrasound (ABUS) and screening mammography (XRM) are combined, compared to screening mammography alone in asymptomatic women with \>50% parenchymal density and a screening mammogram assigned a BI-RADS Assessment Category 1 (negative) or 2 (normal with benign findings).

The effect of the improved Reader performance is illustrated by plotting the ROC curves for XRM alone and XRM+ABUS. If Reader performance improves with the addition of ABUS to the XRM, the area under the curve (AUC) for XRM+ABUS (AUCXRM+ABUS) will be greater than the area under the curve for XRM Alone (AUCXRM Alone). This difference is represented as ∆AUCABUS. The null and alternative hypotheses can be formally expressed as follows:

H0: ∆AUCABUS = 0, AUCXRM+ABUS = AUCXRM Alone The null hypothesis is that Reader performance will be unchanged with the addition of ABUS to a screening mammogram assigned a BI-RADS Assessment Category of 1 or 2.

HA: ∆AUCABUS ≠ 0, AUCXRM+ABUS ≠ AUCXRM Alone The alternative hypothesis is that Reader performance will be changed with the addition of ABUS to a screening mammogram assigned a BI-RADS Assessment Category of 1 or 2. A statistically significant change will be considered equivalent to a statistically significant improvement if the estimated value of AUCXRM+ABUS is greater than that of AUCXRM Alone with statistical significance at an alpha level of .05 for a two-sided test.

The Clinical Retrospective Reader Study is an observational case-controlled, multi-reader multi-case Receiver Operating Characteristic (ROC) study involving approximately 16 Interpreting Physicians (Readers) and approximately 200 breast screening cases which will be reviewed and of those, 164 breast screening cases will be included in the primary data analysis. All primary data analysis cases will consist of screening mammogram and Automated Breast Ultrasound image readings from the same asymptomatic females with \>50% parenchymal density for whom the screening mammogram was assigned a BI-RADS Assessment Category 1 (negative) or 2 (normal with benign findings).

The Readers will review a total of 200 cases: the Non-Cancer Case Set, the Cancer Case Set, and additional Control and Supplemental Case Sets. These cases will be randomized during the reading session so each Reader will review the entire Case Set in a unique order.

The primary Receiver Operating Characteristic analysis will be performed on the Readers' Likelihood of Malignancy (LOM) ratings from their initial review of the screening mammogram alone and their final review of the screening mammogram and Automated Breast Ultrasound for the Non-Cancer Case Set and Cancer Case Set.

CRRS-4 Pivotal Somo•v™ ABUS ROC Reader Observer Study

To Determine the Impact on Reader Performance, as Defined by the Area Under the Receiver Operating Characteristic Curve, When Automated Breast Ultrasound and a Screening Mammogram Are Combined, Compared to a Screening Mammogram Alone in Asymptomatic Women With >50% Parenchymal Density and a Screening Mammogram Assigned a BI-RADS Assessment Category 1 (Negative) or 2 (Normal With Benign Findings).

To determine the impact on Interpreting Physician (Reader) Performance in detecting breast cancer, as defined by the area under the Receiver Operating Characteristic (ROC) Curve (AUC), when ABUS and XRM are combined (XRM+ABUS), compared to XRM Alone in asymptomatic women with \>50% parenchymal density (BI-RADS Composition/Density rating of 3 or 4) and a screening mammogram assigned a BI-RADS Assessment Category 1 (negative) or 2 (normal with benign findings).

Reader sensitivity and specificity when XRM+ABUS are combined compared to XRM Alone for two different combinations of cut points.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Clinical Study to Evaluate Somo•v and Digital Mammography Together as a Breast Cancer Screening Method, Compared to Digital Mammography Alone, in Women With Dense Breasts.	NCT00816530	Breast Cancer	Automated Breas...	25 Years -	U-Systems, Inc.
A Clinical Study to Evaluate Somo•v and Digital Mammography Together as a Breast Cancer Screening Method, Compared to Digital Mammography Alone, in Women With Dense Breasts.	NCT00816530	Breast Cancer	Automated Breas...	25 Years -	U-Systems, Inc.
CRRS-4 Pivotal Somo•v™ ABUS ROC Reader Observer Study	NCT01424956	Breast Cancer	Automated Breas...	-	U-Systems, Inc.

Spots Global Cancer Trial Database for somo•v

Every month we try and update this database with for somo•v cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for somo•v

Every month we try and update this database with for somo•v cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for somo•v cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.