Determination of Optimal Dose and Safety Profile of Optison Ultrasound Contrast Agent in Pediatric Solid Tumor Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- To learn the best dose of Optison™ ultrasound contrast agent that can be safely given to children with abdominal or pelvic tumors.
研究概览
简要总结
St. Jude Children's Research Hospital is studying ways to make ultrasound images clearer - to be able to see blood vessels, body structures, and tumors better. Ultrasound uses sound waves to create pictures, allowing doctors and other medical professionals to "see" inside the body.
Researchers are studying a contrast agent (like a dye) called Optison™. St. Jude Children's Research Hospital researchers want to learn the best and safest dose of this ultrasound "dye."
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 2-20 years old
- •Subject has a known or suspected solid soft tissue tumor in the abdomen or pelvis.
- •Subject is scheduled for other imaging or is already scheduled for an ultrasound or has already had adequate imaging performed at an outside institution.
- •Subject is able to lie still for the exam without sedation.
排除标准
- •Known or suspected hypersensitivity to albumin, blood or blood products.
- •History of open heart surgery, cyanotic congenital heart disease or an axygen saturation of less than 96% as determined by pulse oximetry.
研究组 & 干预措施
1
干预措施: Optison (Drug)
结局指标
主要结局
To learn the best dose of Optison™ ultrasound contrast agent that can be safely given to children with abdominal or pelvic tumors.
时间窗: Unknown-study temporarily closed.
To learn the effects (good and bad) of using Optison during ultrasound.
时间窗: Unknown-study temporarily closed.
To learn if using Optison™ during ultrasound can show the size and location of a tumor, how the tumor is responding to chemotherapy, and whether it has moved into surrounding tissue.
时间窗: Unknown-study temporarily closed.
次要结局
未报告次要终点