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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15,679
- 试验地点
- 11
- 主要终点
- For the cohort of asymptomatic women who have dense breast tissue, calculate the sensitivity of XRM and ABUS together as a breast cancer screening modality and compare it to that of XRM alone.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Asymptomatic
- •Prior screening mammograms, if available, exhibit history of breast density
- •Not currently pregnant or breastfeeding
- •Not planning to become pregnant in the following 18 months
- •Age 25 or older
- •No breast surgeries or interventional procedures in the past 12 months
- •No history of cancer diagnosis and/or treatment in the past 12 months
- •Informed Consent and Completed Participant Questionnaire
- •Complete screening mammography views (CC and MLO) for one or both breasts
- •> 50% preliminary parenchymal density on preliminary assessment by technologist
- •Willing to comply with study protocol and follow-up recommendations:
- •If evaluation is normal, must undergo routine screening mammography in 12 months
- •If evaluation is abnormal, must undergo additional imaging and diagnostic procedures recommended by the Investigator, including but not limited to a biopsy and routine screening mammogram in 12 months if findings are benign.
- •Agrees to report any breast changes or symptoms to the Investigator for the 12 months following study enrollment until and including completion of routine screening mammogram.
- •Agrees to be contacted by site study staff if routine screening mammography or recommended follow-up is not completed within the recommended time frame.
排除标准
- •≤ 50% preliminary parenchymal density on preliminary assessment by technologist
- •Does not meet all Inclusion Criteria for Enrollment
结局指标
主要结局
For the cohort of asymptomatic women who have dense breast tissue, calculate the sensitivity of XRM and ABUS together as a breast cancer screening modality and compare it to that of XRM alone.
时间窗: 18 months
次要结局
- 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.(30 Months)