Trial Outcomes & Findings for Contrast-Enhanced Ultrasound in the Evaluation of Abdominal Injuries in Children (NCT NCT03147690)
NCT ID: NCT03147690
Last Updated: 2021-06-11
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
74 participants
Primary outcome timeframe
At the time the CEUS is performed, within 48 hours of injury.
Results posted on
2021-06-11
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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74
|
|
Overall Study
COMPLETED
|
71
|
|
Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Contrast-Enhanced Ultrasound in the Evaluation of Abdominal Injuries in Children
Baseline characteristics by cohort
| Measure |
All Study Participants
n=74 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.
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|---|---|
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Age, Categorical
<=18 years
|
74 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
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0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Age, Continuous
|
13.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
74 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
All Study Participants
n=74 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.
|
Spleen
All subjects will have a spleen injury identified by CT
|
Right Kidney
All subjects will have a right kidney injury identified by CT
|
Left Kidney
All subjects will have a left kidney injury identified by CT
|
Pancreas
All subjects will have a pancreas injury identified by CT
|
All Organs
All subjects whose central review is complete
|
|---|---|---|---|---|---|---|
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Proportion of Patients for Whom All Organs Identified by CT With Injuries Are Also Identified by CEUS, Regardless of Injury Grade.
|
53 Participants
|
—
|
—
|
—
|
—
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—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
All Study Participants
n=23 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.
|
Spleen
n=40 Participants
All subjects will have a spleen injury identified by CT
|
Right Kidney
n=9 Participants
All subjects will have a right kidney injury identified by CT
|
Left Kidney
n=12 Participants
All subjects will have a left kidney injury identified by CT
|
Pancreas
n=1 Participants
All subjects will have a pancreas injury identified by CT
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All Organs
All subjects whose central review is complete
|
|---|---|---|---|---|---|---|
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For Each Organ, the Proportion of Patients for Whom the Organ is Identified by CT and CEUS as Injured (Regardless of Grade).
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16 Participants
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36 Participants
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6 Participants
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9 Participants
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0 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
All Study Participants
n=23 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.
|
Spleen
n=40 Participants
All subjects will have a spleen injury identified by CT
|
Right Kidney
n=9 Participants
All subjects will have a right kidney injury identified by CT
|
Left Kidney
n=12 Participants
All subjects will have a left kidney injury identified by CT
|
Pancreas
n=1 Participants
All subjects will have a pancreas injury identified by CT
|
All Organs
All subjects whose central review is complete
|
|---|---|---|---|---|---|---|
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Proportion of Injuries Identified by CEUS Which Are Within 1 Grade of the Injury Identified by CT.
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11 Participants
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34 Participants
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4 Participants
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9 Participants
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0 Participants
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—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
All Study Participants
n=55 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.
|
Spleen
n=19 Participants
All subjects will have a spleen injury identified by CT
|
Right Kidney
All subjects will have a right kidney injury identified by CT
|
Left Kidney
All subjects will have a left kidney injury identified by CT
|
Pancreas
All subjects will have a pancreas injury identified by CT
|
All Organs
All subjects whose central review is complete
|
|---|---|---|---|---|---|---|
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Proportion of Patients Where the Absence or Presence of Peritoneal Fluid Identified by CT is Also Identified by CEUS.
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42 Participants
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9 Participants
|
—
|
—
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—
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—
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
All Study Participants
n=68 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.
|
Spleen
n=68 Participants
All subjects will have a spleen injury identified by CT
|
Right Kidney
n=68 Participants
All subjects will have a right kidney injury identified by CT
|
Left Kidney
n=68 Participants
All subjects will have a left kidney injury identified by CT
|
Pancreas
n=68 Participants
All subjects will have a pancreas injury identified by CT
|
All Organs
n=68 Participants
All subjects whose central review is complete
|
|---|---|---|---|---|---|---|
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Proportion of Patients With Agreement Between 'Real-time' and Centralized Interpretation of CEUS Images.
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77.9 percentage of participants
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72.1 percentage of participants
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88.2 percentage of participants
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95.6 percentage of participants
|
98.5 percentage of participants
|
44.1 percentage of participants
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Adverse Events
All Study Participants
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Study Participants
n=74 participants at risk
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.
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|---|---|
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Skin and subcutaneous tissue disorders
Injection Site Reaction
|
1.4%
1/74 • Number of events 1 • Adverse event data was collected from the time of consent until 30 minutes after the second Lumason injection, within 48 hours of the participant's injury.
|
|
Nervous system disorders
Dizziness
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1.4%
1/74 • Number of events 1 • Adverse event data was collected from the time of consent until 30 minutes after the second Lumason injection, within 48 hours of the participant's injury.
|
|
Nervous system disorders
Headache
|
1.4%
1/74 • Number of events 1 • Adverse event data was collected from the time of consent until 30 minutes after the second Lumason injection, within 48 hours of the participant's injury.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place