Detection of Breast Lesions Utilizing iBreast Exam: A Comparison With Clinical Breast Exam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results
研究概览
简要总结
This study will test the iBreastExam device to find out whether it can detect a mass or lump in the breast as accurately as a routine breast cancer screening examination.
The iBreastExam is a handheld device that performs a painless electronic palpation (examination by touch) of the breast. The device is designed to detect breast abnormalities that may require breast imaging and additional clinical examination by a nurse or doctor. The iBreastExam device creates a color map of the breast, with red spots indicating areas that may be abnormal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient
- •Over 18 years of age, able to consent
- •RLC patients presenting to RLC or BAIC for mammogram and CBE
- •Asymptomatic and symptomatic patients will be included
排除标准
- •Male patients
- •Patients under 18 years of age, unable to consent
- •Pregnant patients
- •Lactating patients
- •Non-intact skin
研究组 & 干预措施
Screening Visits for Breast Cancer
Consenting patients will receive their already scheduled standard CBE and mammogram and in addition will receive a breast exam utilizing the iBreast Exam (iBE).
干预措施: Clinical Breast exam (CBE) (Other)
Screening Visits for Breast Cancer
Consenting patients will receive their already scheduled standard CBE and mammogram and in addition will receive a breast exam utilizing the iBreast Exam (iBE).
干预措施: iBreastExam device (Device)
Screening Visits for Breast Cancer
Consenting patients will receive their already scheduled standard CBE and mammogram and in addition will receive a breast exam utilizing the iBreast Exam (iBE).
干预措施: mammogram (Diagnostic Test)
结局指标
主要结局
Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results
时间窗: approximately one month after imaging scan
comparing the calculated the sensitivities or the percentage of true positive breast lesions (based on imaging results) of the iBE and CBE
Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results
时间窗: approximately one month after imaging scan
comparing the calculated the specificities or the percentage of true negative lesions (based on imaging results) of the iBE and CBE
次要结局
未报告次要终点