Evaluation of a Novel Infra-red Breast Imaging System for Risk Assessment in Women at High Risk for Breast Cancer.
Evaluation of REAL IMAGING'S 3D Functional Metabolic Imaging and Risk Assessment ("3D MIRA") System in Women at High Risk for Breast Cancer
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.
研究概览
地位
条件
研究类型
注册 (实际的)
联系人和位置
学习地点
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Ramat-Gan、以色列、5262000
- The Chaim Sheba Medical Center at Tel-Hashomer
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Female
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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Women at high risk 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.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Diagnostic accuracy of 3D MIRA as a breast imaging aid in women with a high risk of breast cancer
大体时间：up to 36 months
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up to 36 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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To test whether repetitive screening with 3D MIRA technology can provide information on the likelihood of developing breast cancer.
大体时间：up to 36 months
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up to 36 months
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合作者和调查者
调查人员
- 首席研究员：Miri Sklair-Levy, MD、The Chaim Sheba Medical Center at Tel-Hashomer
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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