Lymph Node Evaluation in the Axilla of Symptomatic Older Women During Breast Sonography.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Proportion of successful evaluations, defined as the consistent capture of the data for geometry, morphology, qualitative vascular information, and quantitative vascular information on 3 axillary lymph nodes
研究概览
简要总结
This pilot clinical trial studies ultrasound in detecting lymph node metastasis in older patients with undergoing breast sonography. Diagnostic procedures, such as ultrasound, may help find breast cancer and find out how far the disease has spread
详细描述
PRIMARY OBJECTIVES:
I. To develop a reliable and consistent set of guidelines for utilizing diagnostic ultrasound to assess axillary lymph nodes for patient suspicious of breast cancer with possible nodal metastasis.
SECONDARY OBJECTIVES:
I. To explore whether the data collected can be used for pathologic validation of metastatic disease.
OUTLINE:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients referred for a breast ultrasound
- •Patients who have had a mammogram with a Breast Imaging Reporting and Data System (BIRADS) of >= 4
- •Patients who are undiagnosed for breast cancer
排除标准
- •Patients who have had breast cancer surgery
结局指标
主要结局
Proportion of successful evaluations, defined as the consistent capture of the data for geometry, morphology, qualitative vascular information, and quantitative vascular information on 3 axillary lymph nodes
时间窗: at 15 minutes following breast sonogram
The proposed methodology will be considered unfeasible if the proportion of successful evaluations is =\< 0.7.
次要结局
- Accuracy of lymph node geometry, measured with a longitudinal and transverse ratio, to determine guidelines for characterizing micro metastases to the lymph nodes(3 months)
- Accuracy of lymph node morphology, assessed for shape and echogenicity, to determine guidelines for characterizing micro metastases to the lymph nodes(3 months)
- Accuracy of lymphatic flow, measured with spectral doppler, to determine guidelines for characterizing micro metastases to the lymph nodes(3 months)
- Accuracy of lymph node vascularity, assessed with color doppler, to determine guidelines for characterizing micro metastases to the lymph nodes(3 months)