Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Contrast-enhanced ultrasound diagnosis of acute appendicitis
研究概览
简要总结
This study evaluates the ability of contrast-enhanced ultrasound to improve the diagnosis of acute appendicitis in children compared to conventional ultrasound.
详细描述
Acute appendicitis is the most common surgical emergency in children. Diagnostic evaluation for possible appendicitis frequently leads to imaging studies. Magnetic resonance imaging (MRI) and computed tomography (CT) are currently the gold-standard techniques for the diagnosis or exclusion of acute appendicitis. However, these methods not always immediately available; may require administration of intravenous contrast material with the potential for allergic reactions and nephrotoxicity; and, in the case of CT, requires the administration of ionizing radiation that is linked to the long-term development of radiation-induced cancers. The current study will evaluate a potentially safer, radiation-free diagnostic method for acute appendicitis, using contrast-enhanced ultrasound to provide a more accurate means of visualizing the appendix than conventional US imaging.
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
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who have had a conventional abdominal US study to rule out acute appendicitis and are scheduled for an MRI or CT examination.
排除标准
- •Children with serious comorbid conditions, including but not restricted to severe cardiac, pulmonary, renal, or hepatic disease; prior bone marrow or solid organ transplant; cancer; or presence of a ventriculoperitoneal shunt.
- •Children with an allergy to either the active or inactive components of Lumason.
- •Pregnant or nursing patients.
研究组 & 干预措施
IV Contrast-Enhanced US
IV sulfur hexafluoride lipid-type A microspheres, 0.03 mL/kg, 2 doses per examination, total dose not to exceed 4.8 mL. Single examination per patient.
干预措施: Sulfur hexafluoride lipid-type A microspheres (Drug)
结局指标
主要结局
Contrast-enhanced ultrasound diagnosis of acute appendicitis
时间窗: One week
The efficacy of contrast-enhanced US in improving the diagnosis of acute appendicitis compared to conventional US will be assessed.
次要结局
未报告次要终点
研究者
Harriet Joan Paltiel
Associate Professor of Radiology
Boston Children's Hospital