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

Study Overview
=================
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.

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

Conditions
-----------------
Abdominal Injury

Intervention / Treatment
-----------------
* Drug: Lumason


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Study Participants<br>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<br>* 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.<br>* 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Solid Organ Injury