Evaluation of REAL IMAGING'S 3D Functional Metabolic Imaging and Risk Assessment ("3D MIRA") System in Women at High Risk for Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of 3D MIRA as a breast imaging aid in women with a high risk of breast cancer
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 4(RI4) developed by Real Imaging. This technology generates 3D metabolic maps and based on sophisticated machine learning technology, provides objective risk assessment for the presence of malignant tumor. The procedure is non-invasive, comfortable and does not involve ionizing radiation. Moreover, Real Imaging's 3D Functional 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 clinically occult breast cancer in a cohort of women that are at high risk for breast cancer.
We hypothesize that the combination of screening mammography and metabolic screening (3D MIRA) will result in significantly higher breast cancer detection rates.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Woman has read, understood and signed the inform consent form
- •Age: 20 years and older
- •Women who are asymptomatic for breast cancer
- •Proven carriers of deleterious BRCA1 or BRCA2 mutations Or Women that were found to have a lifetime risk of developing breast cancer greater or equal to 20% based on Tyrer-Cuzick, Gail or Clause risk models
- •Women scheduled to undergo routine mammography and/or US or MRI screening
排除标准
- •Women who have had a mammography and/or ultrasound examination performed on the day of the study prior to MIRA scan
- •Women who had a lumpectomy surgery
- •Women who had undergone mastectomy and/or reconstruction
- •Women who have undergone any type of breast surgery throughout the 6 months preceding the study
- •Women who have had a breast biopsy performed throughout the 10 weeks preceding the study.
- •Women who have a fever on the day of the MIRA imaging
- •Women who are pregnant
- •Women who are breast-feeding
- •Women who had undergone breast reduction/augmentation
结局指标
主要结局
Diagnostic accuracy of 3D MIRA as a breast imaging aid in women with a high risk of breast cancer
时间窗: up to 36 months
次要结局
- To test whether repetitive screening with 3D MIRA technology can provide information on the likelihood of developing breast cancer.(up to 36 months)