NCT00821613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
- 1,827
- 试验地点
- 6
研究概览
简要总结
Collection of thermal "images" of women with breast tumors in varying degrees of severity and of healthy women with no breast findings, in order to evaluate and improve Real Imaging's device ("RI4.0"), 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
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
- •Gender: female
- •Age: 18 years and older
- •Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination) summoned for breast biopsy or subjects summoned for a routine screening examination.
- •Subject who have signed an informed consent form.
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 RI4.
- •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 (6)
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