Clinical Utility Study of a Low-Cost Hand-Held Breast Scanner (iBE)
2020年4月3日 更新者：University of Pennsylvania
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
516
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19107
- Pennsylvania Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：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.
|
A bilateral iBE exam will be performed on the entire breast in addition to a clinical breast exam administered by a trained individual.
If the patient is selected to participate in the inter-rater reliability portion of the study, the subject will undergo both the iBE and the clinical breast exams twice sequentially performed by two different separately trained individuals during the same visit.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
通过使用成像结果估计设备的灵敏度，比较 iBE 检查与临床乳房检查 (CBE) 的结果
大体时间：成像扫描后约一个月
|
比较计算的 iBE 和 CBE 的敏感性或真正阳性乳腺病变的百分比（基于成像结果）
|
成像扫描后约一个月
|
|
Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results
大体时间：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
|
approximately one month after imaging
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Position of the Breast Lesion as Measured by iBE and Mammography
大体时间：approximately one month after imaging
|
agreement of the position of the lesion, defined by time coordinate measured by iBE and mammography or ultrasound that fall within a 3 hour time quadrants on a clock of each other.
|
approximately one month after imaging
|
|
Size Detection of the Breast Lesions Identified by iBE
大体时间：approximately one month after imaging
|
The size detected of the breast lesion (cm) by mammogram or ultrasound
|
approximately one month after imaging
|
|
Inter-rate Reliability of the iBE and the CBE Number of Lesions Detected
大体时间：through study completion an average of 18 months
|
comparing the number of breast lesions detected two independent healthcare professionals consecutive evaluations of the same patient with the iBE device and clinical breast exam
|
through study completion an average of 18 months
|
|
Inter-rate Reliability of the iBE and the CBE Position of Lesions Detected
大体时间：through study completion an average of 18 months
|
comparing the position(s) results of two independent healthcare professionals consecutive evaluations of the same patient with the iBE device and clinical breast exam
|
through study completion an average of 18 months
|
|
Post-stratification of the Analysis of the Reliability by Breast Imaging Reporting and Data System Level
大体时间：through study completion an average of 18 months
|
breakdown of the iBE clinically relevant findings and negative findings by the BIRAD levels determination from the gold standard final results
|
through study completion an average of 18 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ari D Brooks, MD、University of Pennsylvania
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年3月1日
初级完成 (实际的)
2017年11月1日
研究完成 (实际的)
2017年12月1日
研究注册日期
首次提交
2015年10月23日
首先提交符合 QC 标准的
2015年11月3日
首次发布 (估计)
2015年11月5日
研究记录更新
最后更新发布 (实际的)
2020年4月6日
上次提交的符合 QC 标准的更新
2020年4月3日
最后验证
2020年4月1日
更多信息
与本研究相关的术语
其他研究编号
- 821412-UPCC24114
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.