NCT00750464已完成不适用
Collection of Raw Data of Thermal Imaging for the Purpose of Developing a Device for Early Detection of Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 575
- 试验地点
- 4
研究概览
简要总结
Collection of thermal "images" of women with breast tumors in varying degrees of severity in order to evaluate and improve Real Imaging's device ("RI3.0") capabilities , which will assist in early detection of breast cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination) requiring a biopsy.
排除标准
- •Subjects who have had a mammography, ultrasound, and/or MRI examination performed on the day of the study, prior to being "imaged" by RI3.
- •Subjects who have undergone any type of breast surgery throughout the 6 weeks preceding the study.
- •Subjects who have had a breast biopsy performed throughout the 6 weeks preceding the study.
- •Subjects who have undergone a mastectomy.
- •Subjects who have a large scar (causing breast deformation) following breast lumpectomy and/or any other cause (e.g. accident).
- •Subjects with prior breast reduction surgery or breast augmentation surgery.
- •Subjects who have a fever on the day of their biopsy.
- •Subjects who are pregnant.
- •Subjects who are breast-feeding.
研究者
研究点 (4)
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