3D Ultrasound Imaging of the Axillary Lymph Nodes
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Lymph node diagnosis by radiologist (benign or malignant) (Aim 2)
研究概览
简要总结
This early phase I studies how well a new 3D ultrasound (3D-US) imaging technology works in evaluating lymph nodes in patients with breast cancer. Ultrasound uses high-frequency sound waves to generate images of the body.
详细描述
PRIMARY OBJECTIVES:
I. Conducting a pilot study to optimize the in vivo performance of the newly developed three-dimensional (3D)-ultrasound (US) technology.
II. Evaluate the performance of the new 3D-US technique in differentiating benign from malignant lymph nodes in patients.
III. Compare the performance of the new 3D-US method with conventional two-dimensional (2D)-US for localizing the clipped lymph nodes.
OUTLINE:
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
- 否
入选标准
- •Patients with lymph node biopsy or lymph node clip placement as per routine clinical care.
- •Age of 18 or older.
排除标准
- •Vulnerable subjects such as prisoners and adults lacking capacity to consent.
结局指标
主要结局
Lymph node diagnosis by radiologist (benign or malignant) (Aim 2)
时间窗: Up to 2 years
Will characterize the lymph node as benign or malignant by reviewing images from each imaging technique based on clinical criteria including node size, shape, margin, cortical thickness, stiffness, and vascularity obtained from B-mode, shear wave elastography, and Doppler imaging. Histopathology results will be used as the ground truth to measure sensitivity and specificity of each ultrasound technology for distinguishing between benign and malignant lymph nodes. The overall agreement of the new 3dimensional (D)-ultrasound (US) method with the biopsy result will be compared to that for 2D-US using McNemar's test. For clipped lymph nodes, the performance of 2D and 3D-US will be compared for localizing the clips.
次要结局
未报告次要终点