NCT03897270招募中不适用
Photoacoustic Imaging of Human Breast
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Identify photoacoustic features of breast malignancies
研究概览
简要总结
This trial studies photoacoustic imaging of the breast in patients with breast cancer and healthy subjects. Dense breasts typically reduce the sensitivity of a mammography and also is associated with a higher risk of breast cancer. Photoacoustic tomography combines light and sound to provide more information about breast tissue.
详细描述
PRIMARY OBJECTIVES:
I. To identify photoacoustic features of breast malignancy and treatment response
OUTLINE:
Participants undergo photoacoustic imaging of the breast over 30 minutes. At subject's discretion, imaging may repeat for a total of 10 studies, each in a separate day.
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
- 是
入选标准
- •Women with clinically suspicious or confirmed breast cancer masses (that have not been surgically removed) and will/have already undergo/undergone breast magnetic resonance imaging (MRI).
排除标准
- •Pregnant women (there are no known risks to these procedures, but any unforeseen risks are as yet undetermined, so pregnant women will be excluded by means of a verbal confirmation at time of screening).
- •Women who have had breast implants in the previous 6 months.
- •Women who have had lumpectomy
- •Adults unable to consent.
- •Individuals who are not yet adults (infants, children, teenagers).
- •Pregnant women.
- •Prisoners.
- •There is no direct benefit of the study to any subject either non-English or English speaker. To facilitate the consent process, we will exclude non-English speaking subjects.
结局指标
主要结局
Identify photoacoustic features of breast malignancies
时间窗: Up to 3 years
Photoacoustic excitation and detection will be performed
次要结局
未报告次要终点
研究者
研究点 (2)
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