Xpress Digital Mammography System Images for Computer Aided Detection Development
A Multi-Center Clinical Study to Acquire Xpress Digital Mammography System Images for Computer Aided Detection Development
研究概览
地位
条件
详细说明
The proposed study is an image acquisition study of mammograms produced by the investigational digital system. Women who meet the selection criteria and who agree to participate in the study will be imaged with the Xpress Digital Mammography System at the clinical sites. These images will be provided to CAD development companies to conduct their own development and testing. The CAD development companies will be responsible for submitting their results to the FDA for marketing approval of their CAD systems.
Patients will be drawn primarily from those women scheduled for breast biopsy since this population has an enhanced probability of cancer. The intent is to enroll patients until at least 107 women with biopsy proven cancers, and at least 330 women who have negative mammograms are enrolled. All cancers found will be used in the study. It is anticipated that approximately 720 patients undergoing diagnostic mammography will need to be enrolled to yield 107 proven cancer cases. In addition, approximately 330 cases will be drawn from a screening population. The negative status of the screening cases will be established by selecting only cases classified as BIRADS 1 or 2, and have a negative mammogram at one year follow-up. All images collected will be utilized to develop and test the CAD systems, and may be used for further product development.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Connecticut
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Waterbury、Connecticut、美国
- Waterbury Hospital
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Florida
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Miami、Florida、美国
- Jackson Memorial Hospital
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Iowa
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Iowa City、Iowa、美国
- University of Iowa
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South Carolina
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Greenville、South Carolina、美国
- Greenville Hospital Systems
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Texas
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San Antonio、Texas、美国
- University of Texas San Antonio
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria
Cases selected for the study must meet all of the following criteria:
- Female
- Scheduled for a routine screening mammography or routine breast biopsy for non-palpable findings
- Any ethnic origin
Exclusion Criteria
Patients meeting any of the following criteria will be excluded from the study:
- Any contraindication to mammography
- Pregnant or suspicion of being pregnant, or nursing
- Patients with palpable lesions
- Patients with internal breast markers in the region of interest
- Breast implants, without displaced views
- Significant recent breast trauma/acute mastitis
- Patient has previously undergone an excisional breast biopsy
- Patients with a history of breast cancer
- Unable or unwilling to give consent
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Screening Patients
Female patients scheduled for routine annual screening mammograms
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Biopsy Patients
Female patients scheduled for routine breast biopsy procedures
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合作者和调查者
调查人员
- 首席研究员：Etta Pisano, MD、Medical University of South Carolina
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.