Evaluation of Real Imaging's 3d Functional Metabolic Imaging and Risk Assessment (Mira) System
试验速览
- 阶段
- 不适用
- 入组人数
- 730
- 试验地点
- 2
- 主要终点
- Sufficient number of cancer case and controls have been imaged
研究概览
简要总结
Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology using the Real Imager 8 (RI8) developed by Real Imaging. This technology generates 3D metabolic maps of the breast and based on sophisticated machine learning technology, provides objective risk assessment for the presence of malignant tumor in the breast. The procedure is non-invasive, comfortable and does not involve ionizing radiation. It is based on acquiring infrared images of the breast. Those images are processed and analyzed by computers to provide the objective risk assessment.
The technology is intended to be used as a screening tool for breast cancer and emerges as highly useful in women for whom screening mammography is sub-optimal, such as women with dense breast. 3D MIRA is unaffected by breast density and is therefore ideal for evaluating patients with mammographically dense breasts.
The purpose of this clinical study is to assess the ability of this novel technology to detect breast cancer in women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1
Testing phase (Phase II) Arm 1 - 180 participant will be enrolled for this arm. Participants will be enrolled to undergo MIRA device imaging. Following the MIRA device imaging procedure, the optimized risk model will assign a binary result to the participant.
All participants will recive standart of care, participants with negative screening exams and a positive MIRA device imaging result will additionally undergo MRI.
干预措施: MIRA device imaging (Device)
Arm 2
Testing phase (Phase II) Arm 2 - 150 participant will be enrolled for this arm. Participants will be enrolled to undergo MIRA device imaging. Following the MIRA device imaging procedure all participants in arm 2 will be following standard of care, MIRA device imaging will NOT change their clinical path.
干预措施: MIRA device imaging (Device)
结局指标
主要结局
Sufficient number of cancer case and controls have been imaged
时间窗: up to 24 months
As this is a data collection study, end point will be reached when approximately 50 women with breast cancer and 100 healthy women (controls) are imaged by the device and sufficient for the comparison statistical analysis.
次要结局
未报告次要终点