Simulated Screening Study of Combined Digital X-Ray, Ultrasound and Photoacoustic Breast Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Evaluation of new breast imaging devices
研究概览
简要总结
This is a pilot, simulated breast cancer screening study. The goal of the study is to explore these scanning modalities:
- Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated ultrasound(AUS)
- Explore the utility of photoacoustic imaging as an adjunct to digital breast tomosynthesis(DBT)/ultrasound(US)alone.
详细描述
This is a pilot, simulated breast cancer screening study. In a population enriched with mammographic call-backs, we will study whether:
- Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated ultrasound(AUS)will result in a lower call-back rate than digital breast tomosynthesis(DBT)alone.
- Explore the utility of photoacoustic imaging as an adjunct to digital breast tomosynthesis(DBT)/ultrasound(US)alone.
This study will compare two new breast imaging systems to digital mammography and hand-held ultrasound that are commonly used to find and evaluate breast masses. Images will be done with digital breast tomosynthesis (DBT) and 3-D automated ultrasound(AUS) which will be done in the breast imaging clinic of the main hospital followed by the second light and ultrasound imaging that will be completed in the research lab.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with possible masses
- •All women should have had mammograms at University of Michigan Health System within 1 year before this research study.
排除标准
- •Women who are physically unable to tolerate the length of the scan.
- •Women who are less than 30 years of age or older than 80 years of age
- •Women who are pregnant or lactating
- •Women whose mass is in an area of the breast which makes it difficult to see in the research scans
- •Womens with a single diagnosis of mammographic calcifications
- •Women who have had a breast cancer with lumpectomy
- •Women who are prisoners
- •Women who are students or staff of investigators
- •Women who cannot give consent
- •Women with mammograms classified as probably benign because of follow-up of a recent benign biopsy.
- •Women with breast pain who have been categorized as BIRADS(Breast Imaging Reporting and Data System) category 0(incomplete) on their most recent mammograms.
- •Males, because their breast tissue is not easily imaged and numbers of potential cases are too few.
结局指标
主要结局
Evaluation of new breast imaging devices
时间窗: 3 years
To determine if photoacoustic imaging is an adjunct to standard of care imaging with regards to quality of imaging. and ultrasound modalities and to determine if combining digital breast tomosynthesis and 3 dimensional automated ultrasound will result in a lower call-back ratio than imaging with digital breast tomosynthesis alone.
次要结局
- Determining the ratio of "patient call backs"(5 years)
研究者
Paul L. Carson Ph.D
Principal Investigator
University of Michigan