Feasibility Study of Contrast Enhanced Intraoperative Ultrasound for Detection and Characterization of Renal Mass Undergoing Open Partial Nephrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Successful Capture of IO-CEUS Images
研究概览
简要总结
The goal of this clinical research is to learn how effective an ultrasound contrast agent, called DEFINITY, is when used during ultrasound-guided surgery to remove part of one or both kidneys.
详细描述
DEFINITY is a contrast agent that is used to create better quality ultrasound images.
On the day before or the day of the standard of care surgery, women who are able to become pregnant must have a negative blood or urine pregnancy test. If it a blood pregnancy test is performed, a portion of blood will be used from routine blood draws that are collected as part of your standard of care surgery.
During your standard of care surgery, the radiologist will take images and videos with an ultrasound machine before you are given the contrast agent. This is done to learn if cancer has spread around the kidney.
You will then receive the DEFINITY by vein over about 1 minute. After you receive the injection of DEFINITY, the radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
Length of Study:
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have previous cross sectional imaging (CT or MRI) demonstrating renal mass or masses that is amenable to open partial nephrectomy.
- •Patient is scheduled for intraoperative ultrasound guided open partial nephrectomy.
- •Patient must sign informed consent, with risks and benefits of CEUS explained (see risks outlined on the following pages)
排除标准
- •Patients with known renal mass scheduled for total or laparoscopic partial nephrectomy.
- •Patients who are hypersensitive to Definity (Perflutren Lipid Microsphere)
- •Patients with known history of right-to-left, bidirectional or transient right-to-left cardiac shunts.
- •Pediatric patients less than 18 years of age.
- •Pregnant or nursing mothers.
研究组 & 干预措施
Contrast Enhanced Intraoperative Ultrasound
During standard of care surgery, radiologist will take images and videos with an ultrasound machine before patient given the contrast agent.
Patient then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
Follow-up phone call 30 days after standard of care surgery is complete to review any side effects patient may be having.
干预措施: Contrast Enhanced Intraoperative Ultrasound (Procedure)
Contrast Enhanced Intraoperative Ultrasound
During standard of care surgery, radiologist will take images and videos with an ultrasound machine before patient given the contrast agent.
Patient then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
Follow-up phone call 30 days after standard of care surgery is complete to review any side effects patient may be having.
干预措施: DEFINITY (Drug)
Contrast Enhanced Intraoperative Ultrasound
During standard of care surgery, radiologist will take images and videos with an ultrasound machine before patient given the contrast agent.
Patient then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
Follow-up phone call 30 days after standard of care surgery is complete to review any side effects patient may be having.
干预措施: Phone Call (Behavioral)
结局指标
主要结局
Successful Capture of IO-CEUS Images
时间窗: 1 day
Primary objective is to determine feasibility of obtaining intraoperative (IO) contrast enhanced ultrasound (CEUS) images in participants undergoing open partial nephrectomy. Feasibility defined as the successful capture of IO-CEUS images in 8 out of 10 participants.
次要结局
- Assess Image Quality of the Contrast Enhanced Ultrasound (CEUS)(1 day)