A prospective multicenter matched-pair clinical study to evaluate the sensitivity and specificity of Automated Breast Ultrasound and Digital X-Ray Mammography together, as a breast cancer screening method, compared to Digital X-Ray Mammography alone, in women with > 50% parenchymal density.

• Background
• Study Synopsis
• Hypothesis
• Objectives
• Endpoint

Background

Breast cancer is one of the most commonly diagnosed cancers in American women with an estimated 254,650 new cases diagnosed in 2009.¹  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.² Early detection reduces breast cancer death rates by 22- 44%; it is for this reason that 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.¹

One thing that is known to interfere with the early detection of breast cancer with mammograms is a woman's breast density. Breast density can make breast cancer difficult for a radiologist to see on a mammogram.^1,3,4 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.⁵ Women who have more fibrous connective and glandular tissue than fatty tissue in their breasts have more breast density. Research has also shown that women who have dense breast tissue are four to six times more likely to develop breast cancer in their lifetime than women who do not have dense breast tissue.³ So, not only do women with increased breast density have a higher risk for breast cancer, their cancers are much harder to detect in early stages with mammography.

Automated Breast Ultrasound (ABUS) is an FDA cleared breast imaging technology which is less affected by a woman's breast density. Today, ABUS is most commonly used in the diagnostic setting, when a woman has a known breast abnormality or symptom. A portion of the data gathered during this study will be used to seek FDA approval to expand the use of ABUS in combination with mammography for routine screening, when there are no breast abnormalities or symptoms. In addition, U-Systems plans to publish the final results from the whole study of more than 20,000 women in peer-reviewed medical journals. The ultimate goal of the entire study is to produce scientific justification for insurance coverage of routine ABUS screening exams.

Citation 1: American Cancer Society. Breast Cancer Facts & Figures 2007-2010
Citation 2: Duffy SW, Tabár L, et al. Cancer. 2002;458-469
Citation 3: Boyd, et al. New England Journal of Medicine 2007;356:227-236
Citation 4: Stone, et al. Cancer Epidemiology, Biomakers & Prevention. 2006;612-617
Citation 5: Kolb, et al. Radiology. 1998;191-199

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Study Synopsis

The SOMO•INSIGHT Study is a prospective multi-center study that is evaluating the improvement in breast cancer detection rates when an Automated Breast Ultrasound (ABUS) exam is performed in addition to a digital mammogram, as part of annual routine breast cancer screening, in women with increased breast density.

The purpose of this study is to determine if combining ABUS together with routine screening mammography is more sensitive to detecting breast cancer in women who have dense breast tissue, than routine screening mammography without ABUS in women who have dense breast tissue. A portion of the data collected will be used in support of a new SCREENING Indication for Use from the United States Food and Drug Administration. If approved, ABUS will be the first and only ultrasound device with a breast cancer screening indication. Once the study is complete, all of the data will be analyzed and the results will be published in peer-reviewed medical journals. These publications, together with reports from other breast ultrasound studies, will help the medical community assure insurance payers of the benefits of screening ABUS so that reimbursement is available for these exams.

The study will enroll more than 20,000 asymptomatic women with dense breast tissue at more than 10 clinical sites across the nation. This study is in direct response to the need for more effective and practical breast cancer screening methods in women with dense breasts.

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Hypothesis

A higher sensitivity to breast cancer detection can be achieved in women with dense breast tissue by performing and reviewing results of ABUS and digital mammography together as part of routine screening, compared to performing and reviewing results of digital mammography alone.

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Objectives

PRIMARY: Calculate the sensitivity (cancer detection rate) of digital mammography and ABUS together as a breast cancer screening modality and compare it to that of digital mammography alone.

SECONDARY: Evaluate the specificity (true positive rate) of digital mammography and ABUS together as a breast cancer screening modality and compare it to that of digital mammography alone. Calculate the negative predictive value (NPV) and positive predictive value (PPV) for XRM and ABUS.

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Endpoint

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

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