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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03147690

Enrollment

Registered

2017-05-10

Start date

2017-11-01

Completion date

2019-10-07

Last updated

2021-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Injury

Keywords

Solid Organ Injury

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.

Interventions

DRUGLumason

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

8 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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: 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.	74
Total	74

Arm

Count

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: 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.

Total

Baseline characteristics

Characteristic	All Study Participants
Age, Categorical <=18 years	74 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants
Age, Continuous	13.3 years
Race (NIH/OMB) American Indian or Alaska Native	1 Participants
Race (NIH/OMB) Asian	3 Participants
Race (NIH/OMB) Black or African American	1 Participants
Race (NIH/OMB) More than one race	3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	64 Participants
Region of Enrollment United States	74 participants
Sex: Female, Male Female	21 Participants
Sex: Female, Male Male	53 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 74
other Total, other adverse events	3 / 74
serious Total, serious adverse events	0 / 74

Outcome results

Primary

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.