3D Multimodal Ultrasound Imaging for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- BI-RADS Score
研究概览
简要总结
The purpose of this research is to study the efficacy of a new ultrasound imaging method for diagnosis of breast mass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women ≥ 18 years of age.
- •solid breast lesion and ultrasound guided biopsy (either as part of their clinical care or through participation in other IRB-approved studies)
- •lesion size of 3mm or larger
排除标准
- •< 18 years of age.
- •Lacking capacity to consent
- •Pregnant or lactating
- •Receiving cancer therapy such as chemotherapy or radiation therapy
研究组 & 干预措施
Clinically indicated breast tumor biopsy
Subjects with breast lesion and are scheduled for clinically-indicated biopsy will have 3D Multimodal Ultrasound Imaging performed
干预措施: GE Logiq E10 clinical ultrasound scanner (Diagnostic Test)
Clinically indicated breast tumor biopsy
Subjects with breast lesion and are scheduled for clinically-indicated biopsy will have 3D Multimodal Ultrasound Imaging performed
干预措施: Verasonics research scanner (Diagnostic Test)
结局指标
主要结局
BI-RADS Score
时间窗: Baseline
BI-RADS scores will be obtained using 2D B-mode ultrasound images from the GE Logiq E10 clinical scanner, and using 3D B-mode images from the Verasonics scanner. A 7-point BI-RADS scale will be used, with a score of 1, 2, or 3 considered negative and 4a, 4b, 4c, and 5 considered positive.
次要结局
未报告次要终点