Contrast Ultrasound for Pediatric Trauma - Comparative Evaluation (CAPTURE Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- David Mooney
- 入组人数
- 68
- 试验地点
- 5
- 主要终点
- Overall CEUS/CT Concordance for all study participants
研究概览
简要总结
This multicenter study aims to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric patients. Up to 130 subjects will complete the study across approximately 5-10 sites in the US, with up to 30 patients in the training phase (3 per site) and 100 patients in the treatment phase of the study. All subjects will have had a CT scan as part of standard of care, confirming at least one solid organ abdominal injury. The study procedure will occur within 48 hours from time of injury. All subjects will have an abdominal ultrasound without contrast, followed by a contrast-enhanced ultrasound using the contrast agent Lumason. Ultrasound and contrast-enhanced ultrasound results will be compared to the CT scan results. The CT and ultrasound scans will be read locally and will undergo central review.
详细描述
This is an interventional study which proposes to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric trauma patients. Up to 130 subjects will be enrolled across approximately 5 to 10 sites in the US. Each site, including the coordinating center, will undergo the training phase; each site will enroll 3 participants in this phase successfully prior to entering the treatment phase. All subjects will have had a Computerized Tomography (CT) scan as part of standard of care, confirming at least one solid organ abdominal injury. All subjects will have an abdominal ultrasound without contrast, followed by a contrast-enhanced ultrasound using the contrast agent Lumason. Ultrasound and contrast-enhanced ultrasound results will be compared to the CT scan results. The study procedures will take place within 48 hours of injury. At conclusion of enrollment of all subjects a centralized review of CT vs. CEUS will occur to compare to real-time readings.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemodynamically stable, as determined by the trauma team
- •Age 8 through 18 years (inclusive)
- •Interpretable CT of the abdomen and pelvis that demonstrates at least one solid organ injury among the liver, spleen, pancreas, and kidneys
- •Plan for observation or admission to the hospital
- •Candidate for abdominal ultrasound based on body habitus, as determined by the investigator
- •Glasgow Coma Score of 15
- •Able to complete the study procedures within 48 hours of injury
排除标准
- •Known cardiac abnormality
- •Pulmonary Hypertension
- •Known sensitivity to any Lumason components - including sulfur hexafluoride, polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), or palmitic acid
- •Unable to be rolled onto side to allow lateral ultrasound windows if necessary
- •Unable to assent or consent
- •CT images not available for transmission to central image repository
研究组 & 干预措施
All Study Participants
All subjects will have an abdominal non-contrast ultrasound performed. Lumason will then be administered at a dose of 0.03mL/kg up to a maximum dose of 2.4mL and a contrast-enhanced ultrasound will be performed. The dose will be given twice, for a total maximum dose per subject of 4.8mL
干预措施: Lumason (Drug)
结局指标
主要结局
Overall CEUS/CT Concordance for all study participants
时间窗: At the time the CEUS is performed, within 48 hours of injury
A patient is classified as having a "concordant" assessment if each organ identified by CT with injuries is exactly identified by CEUS, regardless of injury grade, by the local study site reviewer. Otherwise, a patient is classified as having a "discordant" assessment.
次要结局
- Real-time/Centralized CEUS Concordance(At the time the CEUS is performed, within 48 hours of injury.)
- Organ-specific CEUS/CT Concordance(At the time the CEUS is performed, within 48 hours of injury)
- Peritoneal Fluid CEUS/CT Concordance(At the time the CEUS is performed, within 48 hours of injury.)
- Grade-specific Overall CEUS/CT Concordance(At the time the CEUS is performed, within 48 hours of injury)
研究者
David Mooney
Director Trauma Program
Boston Children's Hospital