NCT01029977撤回不适用
Imaging Modality Effects on the Multi-dimensional InfraRed Analysis (MIRA) Technology
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to evaluate the effect of everyday practice modalities (mammography, US) on the MIRA technology.
详细描述
The objective of the current clinical study is to collect sufficient MIRA imaging data of subjects arriving for a routine screening mammography, before and after they undergo the mammography. This is in order to reach a conclusion whether the the firm breast compression involved in the mammography procedure affects the performance of the MIRA technology. At the current stage of the development of the device, the goal of this clinical trial is in no way to arrive at a statistical analysis.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gender: female
- •Age: 50 years and older
- •Subjects summoned for a routine screening mammography, ultrasound, diagnostic mammography or breast biopsy.
- •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 their FIRST imaging session with the RealImager.
- •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 undergone a lumpectomy.
- •Subjects who have a large scar (causing breast deformation).
- •Subjects who have previously undergone or are currently undergoing breast radiation therapy.
- •Subjects who have previously undergone or are currently undergoing chemotherapy.
- •Subjects with prior breast reduction surgery or breast augmentation surgery.
- •Subjects who are pregnant.
- •Subjects who are breast-feeding.
研究者
研究点 (1)
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