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

A Multicenter Trial of Contrast-Enhanced Ultrasound in the Evaluation of Abdominal Solid Organ Injuries in Pediatric Trauma

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.

Study Overview

• Status: Terminated
• Conditions: Abdominal Injury
• Intervention / Treatment: Drug: Lumason

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 Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's Hospital
  • California
    • Palo Alto, California, United States, 94304
      • Lucile Packard Children's Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 45202
      • Riley Children's Health
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Kansas City
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Primary Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Lumason; 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 Names: SonoVue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients for Whom All Organs Identified by CT With Injuries Are Also Identified by CEUS, Regardless of Injury Grade.	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.	At the time the CEUS is performed, within 48 hours of injury.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
For Each Organ, the Proportion of Patients for Whom the Organ is Identified by CT and CEUS as Injured (Regardless of Grade).	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.	At the time the CEUS is performed, within 48 hours of injury.
Proportion of Injuries Identified by CEUS Which Are Within 1 Grade of the Injury Identified by CT.	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.	At the time the CEUS is performed, within 48 hours of injury.
Proportion of Patients Where the Absence or Presence of Peritoneal Fluid Identified by CT is Also Identified by CEUS.	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.	At the time the CEUS is performed, within 48 hours of injury.
Proportion of Patients With Agreement Between 'Real-time' and Centralized Interpretation of CEUS Images.	The contrast-enhanced ultrasounds will be re-read by a centralized reviewer and the results compared to those from the real-time reading.	At the time the CEUS is performed, within 48 hours of injury.

Collaborators and Investigators

• Sponsor: David Mooney
• Investigators: Principal Investigator: David Mooney, MD, MPH, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): October 7, 2019
• Study Completion (Actual): October 7, 2019

Study Registration Dates

• First Submitted: April 27, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 3, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Solid Organ Injury
• Additional Relevant MeSH Terms: Wounds and Injuries; Abdominal Injuries
• Other Study ID Numbers: P00025242

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No