Evaluation of the Bexa Breast Examination (BBE) As an Effective Solution to Breast Cancer Early Detection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Bexa Sensitivity of Mass Detection
研究概览
简要总结
Objective:
The "Bexa Breast Exam," or "BBE," for the purposes of this study is defined as the use of a Bexa device in conjunction with a portable, focused ultrasound examination to identify and further evaluate abnormal breast masses including cancer. Commercially, this combination of Bexa plus focused ultrasound is called "Bexa Breast ExamTM," and abbreviated as, "BBE." This study compares the Bexa Breast Exam (BBE) to the standard of care (digital breast tomosynthesis) in detecting masses and as a breast cancer early detection examination.
The specific objectives are:
- To measure the sensitivity and specificity of BBE as compared to digital breast tomosynthesis in the general population of women over 30 without a history of breast cancer.
- To measure the sensitivity and specificity of BBE as compared to digital breast tomosynthesis identifying breast masses including cancer in women with dense breasts.
- To demonstrate the proportion of women receiving a BBE that require additional imaging studies.
Hypothesis:
The purpose of this study is to demonstrate that the Bexa Breast Examination's sensitivity and specificity in identifying abnormal breast masses is comparable to the current accepted standard of care, mammography with tomosynthesis.
详细描述
Background and Significance:
Breast cancer is the second leading cause of cancer deaths among women in the United States. It is estimated that 287,850 women were diagnosed with breast cancer in 2022, of which 43,250 will die. The current recommended form of screening for breast cancer is mammography, followed by the Clinical Breast Exam, "CBE". However, CBE is subjective, highly variable depending upon training and experience, and lacks the level of sensitivity needed to consistently detect breast masses including cancer.
Mammography can be painful, irradiates the breast, is available primarily in intimidating hospital and/or medical clinic locations and requires physician interpretation. As well, screening mammography results are typically provided to the woman days to weeks after the examination. In a study of 405,191 mammogram examinations, 20% of breast cancers were missed, and 12-14% of examinations had false positives results. A study published in the February 2016 Annals of Internal Medicine posited that among women receiving annual mammography, the radiation exposure caused 246 cancers per 100,000 women over a 10-year period.
Screening mammography is not adopted by between 30% and 60% of American women over 40, with exaggerated challenges to adoption in the African American and Hispanic communities. Mammography is historically not offered to younger women, because it is inaccurate in their denser breast tissue. Over the past decade, the United States Preventive Services Task Force (USPSTF) has acted to limit the use of mammography in women 40-49 due to the high rate of false positive examinations. This has further expanded the population of women at risk for breast cancer without an effective early detection option. While annual screening remains the ideal screening frequency to achieve early detection, screening mammography recommendations from the USPSTF are driving the transition towards mammograms in women over 50 to every 24 to 36 months, primarily as a tactic to limit radiation exposure. However, this approach renders the women between the ages of 40 and 50 with no options for screening and early detection.
Globally, less than 5% of at-risk age women will ever receive screening mammography, primarily due to the expense of the equipment and of the supporting radiology operations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
Open label study; no masking
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who present to receive a screening mammogram.
- •Women of all races, ethnicities, and socio-economic backgrounds.
- •Signed informed consent obtained prior to any study assessments and procedures.
- •Age 30-75 years of age and female.
排除标准
- •Women with findings that are < 0.5 cm or > 3.5 cm
- •Palpable lesion (to the participant)
- •Positive clinical findings that cause a visible and obvious deformity of the breast or alteration in the skin appearance of the breast.
- •Women with breast tenderness significant enough to prevent completion of any of the study examinations. (Both ultrasound and Bexa require a light degree of pressure on the breast; certain women, very few, have enough breast tenderness that they cannot tolerate the pressure of either Bexa or ultrasound. Mammograms exert substantially more pressure on the breast.)
- •Women with breast significant skin scarring enough to prevent effective BBE (e.g., keloid scarring of the breast, for example), because extensive, hard surface scarring introduces artifact in the Bexa exam. Participant exclusion will be determined by the Bexa examiner.
- •Greater than 3 positive findings in a given breast.
- •Women who are unable to comprehend or unwilling to sign an informed consent form.
- •Women ages < 30 and > 75 years of age.
- •Pregnant women.
- •Women who have had a mastectomy - unilateral or bilateral.
- •Women who have had a recent (past 30 days) biopsy performed.
- •Women who have had a prior history of breast cancer in either breast.
- •Women who have had radiation to the breast.
- •Women who have had any breast surgery within the last 12 months.
结局指标
主要结局
Bexa Sensitivity of Mass Detection
时间窗: During procedure
Bexa sensitivity of mass detection as compared to digital tomosynthesis mammography
次要结局
- False Negative Comparison between Bexa and Mammography(During procedure)
- Bexa Detected Breast Cancers(8 weeks)