3D Ultrasound Microvessel Imaging for Breast Masses
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Ultrasound parameters accuracy using McNemar's test
研究概览
简要总结
This early phase I trial studies how well 3D ultrasound microvessel imaging works for the diagnosis of breast mass. The 3D ultrasound microvessel imaging technology demonstrates significantly increased vessel detection sensitivity over conventional doppler methods without the need of using contrast agents. This study may improve cancer diagnosis and reduce unnecessary biopsy on benign tumors.
详细描述
PRIMARY OBJECTIVES:
I. Optimization of imaging protocol for this new ultrasound technology. II. Investigate the diagnostic performance of the new ultrasound technology using clinically indicated biopsy as the reference standard.
OUTLINE:
Patients undergo 3 dimensional (D) ultrasound microvessel imaging over 45 minutes. Patients' medical records are reviewed.
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
- 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
- 是
入选标准
- •Women with solid breast lesion who are scheduled for a clinically indicated ultrasound-guided biopsy.
- •Lesion size of 3 mm or larger.
- •Age 18 or greater.
排除标准
- •Women with previous breast surgery or breast implant.
- •Lacking the capacity to consent.
- •Women who are pregnant or lactating.
- •Women who are receiving cancer therapy such as chemotherapy or radiation therapy.
结局指标
主要结局
Ultrasound parameters accuracy using McNemar's test
时间窗: Up to 1 year
Will include diagnostic performance parameters (accuracy) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Ultrasound parameters vs. Breast Image Reporting using McNemar's test
时间窗: Up to 1 year
Will include Breast Imaging Reporting calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Ultrasound parameters negative predictive value using McNemar's test
时间窗: Up to 1 year
Will include diagnostic performance parameters (negative predictive value) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better. .
Ultrasound diagnostic accuracy using McNemar's test
时间窗: Up to 1 year
Will be compared between conventional ultrasound (US) and conventional US + 3 dimensional (D) ultrasound microvessel imaging (UMI) using McNemar's test.
Ultrasound parameters positive predictive value using McNemar's test
时间窗: Up to 1 year
Will include diagnostic performance parameters (positive predictive value) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Ultrasound parameters specificity using McNemar's test
时间窗: Up to 1 year
Diagnostic sensitivity comparison between conventional US versus US + 3D-UMIl using the McNemar's test. Scale = Max 100%, Min 0% - The higher, the better.
Ultrasound parameters calculated by McNemar's test
时间窗: Up to 1 year
Will include Data System (BI-RADS) score calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Ultrasound parameters sensitivity using McNemar's test
时间窗: Up to 1 year
Will include diagnostic performance parameters (sensitivity) calculated based on the BI-RADS score.
次要结局
未报告次要终点