Contrast-Enhanced Ultrasound in the Evaluation of Abdominal Injuries in Children

Phase 1

Terminated

• Conditions: Abdominal Injury
• Interventions: Drug: Lumason

• Registration Number: NCT03147690
• Lead Sponsor: David Mooney

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 Description

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.

Study Timeline

• Study First Submitted: 2017-04-27
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-10
• Study Start: 2017-11-01
• Primary Completion: 2019-10-07
• Study Completion: 2019-10-07
• Results First Submitted: 2020-10-01
• Results First Submitted QC: 2020-11-15
• Results First Posted: 2020-12-10
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-03
• Last Update Posted: 2021-06-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Hemodynamically stable, as determined by the trauma team
• Age 8 through 17 years
• Interpretable CT of the abdomen and pelvis that demonstrates at least one abdominal 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
• Have a Glasgow Coma Score of 15
• Able to complete the study procedures within 48 hours of injury

Exclusion Criteria

• Known cardiac abnormality
• Pulmonary hypertension
• Known sensitivity to sulfur hexafluoride, polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), or palmitic acid
• Unable to roll over
• Unable to assent
• Pregnant
• Lactating
• CT images not available for transmission to central image repository

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Study Participants	Lumason	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

Primary Outcome Measures

Name	Time	Method
Proportion of Patients for Whom All Organs Identified by CT With Injuries Are Also Identified by CEUS, Regardless of Injury Grade.	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.

Secondary Outcome Measures

Name	Time	Method
For Each Organ, the Proportion of Patients for Whom the Organ is Identified by CT and CEUS as Injured (Regardless of Grade).	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.	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.	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.	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.

Trial Locations

Locations (8)

Riley Children's Health; 🇺🇸 Indianapolis, Indiana, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Nationwide Children's; 🇺🇸 Columbus, Ohio, United States

Lucile Packard Children's Hospital; 🇺🇸 Palo Alto, California, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States

Children's Mercy Kansas City; 🇺🇸 Kansas City, Missouri, United States

Primary Children's Hospital; 🇺🇸 Salt Lake City, Utah, United States