Clinical Utility of a Low-Cost Hand-Held Breast Scanner
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Number of Quadrants With Detected Breast Lesions
研究概览
简要总结
Early detection of breast cancer improves the survival rate and makes treatment less costly. This study would measure the accuracy a low-cost hand-held commercially viable device, iBE, for the detection of clinically relevant findings in the breast using the results of current mammography as a comparison. This research will have no impact on clinical decision making.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age and older
- •Women and men with symptomatic breast lump (either by palpation or imaging) OR
- •Asymptomatic women presenting to the imaging center for a screening mammogram.
- •Signed Informed Consent
排除标准
- •Patients under 18 years of age
- •Patients who previously participated in this study and are returning to the Women's Imaging Center for follow-up diagnostic tests
结局指标
主要结局
Number of Quadrants With Detected Breast Lesions
时间窗: 3 months
The iBE results were evaluated by definitive quadrants. The definitive quadrants break down the superimposed clock into 4 equal sectors (e.g. 12-3, 3-6, 6-9, 9-12).
Sensitivity of iBE Breast Lesion Detection
时间窗: 1 day
the number of quadrants with positive breast lesion detected by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant. 77 quadrants were labeled positive for breast lesion by iBE, 66 were confirmed positive by mammogram or ultrasound allowing calculation of sensitivity of the the iBE breast lesion detection
Specificity of iBE Breast Lesion Detection
时间窗: 1 day
the number of quadrants characterized normal breast by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant
次要结局
未报告次要终点