Evaluation of Renal Masses Using Ultrasound Intravenous Microbubble Contrast
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To determine the accuracy of contrast enhanced ultrasound of renal masses to predict benign vs. malignant histology
研究概览
简要总结
The purpose of this study is to evaluate the blood flow in kidney masses by using ultrasound microbubble contrast material, and to see if results from ultrasound contrast studies can predict if a kidney mass is benign or malignant. Patterns of blood flow in the kidney mass will be examined to see if:
- benign kidney masses can be distinguished from kidney cancers and
- if slow growing, lower risk cancers have different blood flow compared to clear cell cancer which is the most common type of kidney cancer.
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
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any adult patient who is planned or scheduled for surgical excision or biopsy of a solid or complex cystic renal mass would be eligible for the study
- •Histology of the renal mass must be unknown at the time of enrollment
- •Patients who have renal masses that are evident on conventional US imaging
- •Patients will have a correlative abdominal CT and/or MRI
排除标准
- •Patients with any history of cardiac shunts.
- •Patients with history of pulmonary hypertension or unstable cardiopulmonary conditions, including patients on mechanical ventilation.
- •Patients without peripheral IV access
- •Pregnant patients and children
- •Patients with any known contrast allergies, allergy to perflutren, or any components of Definity or microbubble contrast
- •Patients who have renal masses that are not evident on conventional US imaging
研究组 & 干预措施
1
Patients entering into this protocol will also have a preoperative renal contrast enhanced US for this research study. Renal mass US contrast enhancement results will be compared with surgical pathological findings to determine if contrast enhancement patterns of the renal masses correlate with benign and malignant histopathology, and/or malignant histologic subtype.
干预措施: Ultrasound with intravenous microbubble contrast injection (Drug)
结局指标
主要结局
To determine the accuracy of contrast enhanced ultrasound of renal masses to predict benign vs. malignant histology
时间窗: conclusion of study
次要结局
- To determine if clear cell renal malignancies can be predicted, or differentiated, from other less aggressive malignant subtypes, based on analysis of the data.(conclusion of study)
- To determine if contrast enhanced ultrasound of renal masses provides added value in predicting benign vs. malignant histology, when compared to the current routine evaluation of CT or MRI, and standard grey scale and Doppler US(conclusion of the study)