Clinical Utility Study of a Low-Cost Hand-Held Breast Scanner
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 516
- 试验地点
- 1
- 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
The primary purpose of this study is to measure the clinical utility (accuracy) of the hand-held breast scanner (iBE) for the detection of breast lesions or lumps. The iBE results will be compared to the results of a current mammogram and/or ultrasound. The duration of study participation is approximately 30 minutes one day.
详细描述
The FDA approved class II device in this clinical trial is a low-cost hand-held breast scanner (intelligent Breast Exam, iBE). This device is to be used a pre-screening tool for mammograms or ultrasounds. Determination of the accuracy of iBE for the detection of clinically relevant breast lesions will be performed by means of a prospective study.
The iBE evaluation will be performed by a trained licensed practical nurse or ultrasound technologist who is blinded to the outcome of the radiology studies at the time the iBE is performed. The iBE training will be done by the leading iBE user in the United States. The iBE evaluation will be done prior to the patient's original scheduled imaging visit. After the completion of the imaging visit the radiologist will evaluate the mammogram and/or ultrasound images along with the iBE report.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age and older
- •Women and men with symptomatic breast lump (either by palpation or imaging) OR
- •Asymptomatic women presenting to the imaging center for a screening mammogram
- •Signed Informed Consent
排除标准
- •Patients under 18 years of age
- •Patients who previously participated in this study and are returning to the Women's Imaging Center for follow-up diagnostic tests
研究组 & 干预措施
intelligent Breast Exam, iBE
Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment. No return visit required for participation.
干预措施: intelligent Breast Exam, iBE (Device)
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
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
- Inter-rate Reliability of the iBE and the CBE Position of Lesions Detected(through study completion an average of 18 months)
- Position of the Breast Lesion as Measured by iBE and Mammography(approximately one month after imaging)
- Size Detection of the Breast Lesions Identified by iBE(approximately one month after imaging)
- Inter-rate Reliability of the iBE and the CBE Number of Lesions Detected(through study completion an average of 18 months)
- Post-stratification of the Analysis of the Reliability by Breast Imaging Reporting and Data System Level(through study completion an average of 18 months)