Contrast-Enhanced Ultrasound in the Evaluation of Abdominal Injuries in Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03147690|
Recruitment Status : Terminated (Stopped for futility)
First Posted : May 10, 2017
Results First Posted : December 10, 2020
Last Update Posted : June 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Injury||Drug: Lumason||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Trial of Contrast-Enhanced Ultrasound in the Evaluation of Abdominal Solid Organ Injuries in Pediatric Trauma|
|Actual Study Start Date :||November 1, 2017|
|Actual Primary Completion Date :||October 7, 2019|
|Actual Study Completion Date :||October 7, 2019|
Experimental: 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
Lumason will be administered at a dose of 0.03 mL/kg up to a maximum dose of 2.4mL injected into a peripheral intravenous catheter. An abdominal contrast enhanced ultrasound will be performed to look for solid organ injury. The will be given twice during the intervention, for a total maximum dose per subject of 4.8mL.
Other Name: SonoVue
- Proportion of Patients for Whom All Organs Identified by CT With Injuries Are Also Identified by CEUS, Regardless of Injury Grade. [ Time Frame: At the time the CEUS is performed, within 48 hours of injury. ]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.
- For Each Organ, the Proportion of Patients for Whom the Organ is Identified by CT and CEUS as Injured (Regardless of Grade). [ Time Frame: At the time the CEUS is performed, within 48 hours of injury. ]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: At the time the CEUS is performed, within 48 hours of injury. ]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: At the time the CEUS is performed, within 48 hours of injury. ]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: At the time the CEUS is performed, within 48 hours of injury. ]The contrast-enhanced ultrasounds will be re-read by a centralized reviewer and the results compared to those from the real-time reading.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03147690
|United States, Arizona|
|Phoenix Children's Hospital|
|Phoenix, Arizona, United States, 85016|
|United States, California|
|Lucile Packard Children's Hospital|
|Palo Alto, California, United States, 94304|
|United States, Indiana|
|Riley Children's Health|
|Indianapolis, Indiana, United States, 45202|
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, Missouri|
|Children's Mercy Kansas City|
|Kansas City, Missouri, United States, 64108|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Columbus, Ohio, United States, 43205|
|United States, Utah|
|Primary Children's Hospital|
|Salt Lake City, Utah, United States, 84113|
|Principal Investigator:||David Mooney, MD, MPH||Boston Children's Hospital|