NCT02777164终止不适用
Evaluation of a Three Dimensional Functional Metabolic Imaging and Risk Assessment System for Classifying Women at High Risk of Breast Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 740
- 试验地点
- 2
- 主要终点
- The difference in the area under the ROC curve (AUC) of mammography plus MIRA compared to mammography alone.
研究概览
简要总结
The objective of the study is to estimate the diagnostic accuracy of cancer detection when MIRA technology is combined with mammography, by evaluating the area under the ROC curve (AUC) of mammography vs. mammography plus MIRA. This evaluation will be done in a Reader Study on a subset of women with histology confirmed cancer and healthy women with dense breast.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •A. Subjects who are asymptomatic and scheduled to undergo routine screening mammography
- •B. Subjects scheduled for image guided needle biopsy as a result of findings obtained during standard of care imaging modalities
- •C. Subjects has a prior mammogram and have been diagnosed with extremely or heterogeneously dense breast tissue (Density C or D)
排除标准
- •Male by birth.
- •Individual is less than 30 and greater than 70 years old.
- •Contraindication to bilateral mammography or MRI
- •Subjects who are unable to read, understand and execute the informed consent procedure.
- •Subjects who have had mammography ultrasound or MRI examination performed on the day of the study prior to MIRA scan.
- •Subjects who have significant existing breast trauma.
- •Subjects who have undergone lumpectomy/mastectomy.
- •Subjects who have undergone breast reduction or breast augmentation.
- •Subjects who have undergone any other type of breast surgery, excluding surgical biopsy.
- •Subjects who have large breast scar / Breast deformation
- •Subjects who have undergone a breast needle biopsy or a surgical biopsy within the 6 month period prior to their intended enrollment into the study.
- •Subjects who have a temperature > 100° F (37.8C) degrees on the day of the MIRA imaging
- •Subjects who are pregnant or lactating
- •Subjects with known Raynaud's Disease
- •Subjects that are claustrophobic or have physical limitations that do allow them to sit in the system chair for the required imaging session.
- •Subjects with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices
- •Subject with kidney failure
- •Subject with known allergy to gadolinium
- •Subject with a history of multiple contrast MRI scans (more than 4 MRI scans over the past two year)
- •Inmates (45 CFR 46.306) or mentally disabled individuals
- •Subjects with a BI-RADS category 6 (e.g. for which mammogram was performed for the purpose of planning cancer therapy)
- •Subjects currently participating in another investigational clinical study
- •Subjects who participated in the Calibration Phase will not be able to participate in the Testing Phase
研究组 & 干预措施
MIRA device imaging
Experimental
MIRA Device imaging for adjunctive detection of breast cancer
干预措施: MIRA device imaging (Device)
结局指标
主要结局
The difference in the area under the ROC curve (AUC) of mammography plus MIRA compared to mammography alone.
时间窗: 19 months
次要结局
未报告次要终点
研究者
研究点 (2)
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