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 ]

During analysis, results of contrast enhanced ultrasound will be compared to results of CT scan that was performed as part of clinical care to determine if the organs identified as injured by CT were also identified as injured by CEUS.


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