Clinical Trial: Contrast-Enhanced Ultrasound in the Evaluation of Abdominal Injuries in Children
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: A Multicenter Trial of Contrast-Enhanced Ultrasound in the Evaluation of Abdominal Solid Organ Injuries in Pediatric Trauma
Brief Summary: This study proposes to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric patients. 146 subjects will be enrolled across approximately 8 sites in the US. 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.
Detailed Summary: This is an interventional study proposes to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric patients. 146 subjects will be enrolled across approximately 8 sites in the US. 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.
Sponsor: David Mooney
Current Primary Outcome: Proportion of patients for whom all organs identified by CT with injuries are also identified by CEUS, regardless of injury grade. [ Time Frame: 24 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- For each organ, the proportion of patients for whom the organ is identified by CT and CEUS as injured. [ Time Frame: 24 months ]Results will be categorized by organ and analyzed to determine the percentage of injuries for each organ that were identified by CT that were also identified by CEUS.
- Proportion of injuries identified by CEUS which are within 1 grade of the injury identified by CT. [ Time Frame: 24 months ]The grade for the severity of the injury as determined by CEUS will be compared to the grade for the severity of the injury as determined by CT scan.
- Proportion of patients where the absence or presence of peritoneal fluid identified by CT is also identified by CEUS. [ Time Frame: 24 months ]The presence or absence of peritoneal fluid as determined by CEUS will be compared to the presence or absence of peritoneal fluid as determined by CT scan.
- Proportion of patients with agreement between 'real-time' and centralized interpretation of CEUS images. [ Time Frame: 24 months ]The contrast-enhanced ultrasounds will be re-read by a centralized reviewer and the results compared to those from the real-time reading.
Original Secondary Outcome: Same as current
Information By: Boston Children’s Hospital
Dates:
Date Received: April 27, 2017
Date Started: June 2017
Date Completion: December 2019
Last Updated: May 9, 2017
Last Verified: May 2017