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

• Sponsor: David Mooney (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03147690
• Collaborator: (none)
• Enrollment: 74
• Locations: 8
• Arm: 1
• Actual Duration (Months): 23.2
• Patients Per Site: 9.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Injury	Drug: Lumason	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Multicenter Trial of Contrast-Enhanced Ultrasound in the Evaluation of Abdominal Solid Organ Injuries in Pediatric Trauma
• Actual Study Start Date: Nov 1, 2017
• Actual Primary Completion Date: Oct 7, 2019
• Actual Study Completion Date: Oct 7, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phoenix Children's Hospital	Phoenix	Arizona	United States	85016
2	Lucile Packard Children's Hospital	Palo Alto	California	United States	94304
3	Riley Children's Health	Indianapolis	Indiana	United States	45202
4	Boston Children's Hospital	Boston	Massachusetts	United States	02115
5	Children's Mercy Kansas City	Kansas City	Missouri	United States	64108
6	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
7	Nationwide Children's	Columbus	Ohio	United States	43205
8	Primary Children's Hospital	Salt Lake City	Utah	United States	84113

Sponsors and Collaborators

• David Mooney

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 16, 2019

More Information

Publications

None provided.

• Responsible Party: David Mooney, Director Trauma Program, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT03147690
• Other Study ID Numbers: P00025242
• First Posted: May 10, 2017
• Last Update Posted: Jun 11, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Keywords provided by David Mooney, Director Trauma Program, Boston Children's Hospital: Solid Organ Injury
• Additional relevant MeSH terms: Wounds and Injuries; Abdominal Injuries

Study Results

Participant Flow

Arm/Group Title	All Study Participants
Arm/Group Description	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.
Period Title: Overall Study
STARTED	74
COMPLETED	71
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	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.
Overall Participants	74
Age (Count of Participants)
<=18 years	74 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	13.3
Sex: Female, Male (Count of Participants)
Female	21 28.4%
Male	53 71.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.4%
Asian	3 4.1%
Native Hawaiian or Other Pacific Islander	2 2.7%
Black or African American	1 1.4%
White	64 86.5%
More than one race	3 4.1%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	74 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Study Participants
Arm/Group Description	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.
Measure Participants	74
Count of Participants [Participants]	53 71.6%

2. Secondary Outcome

Title	For Each Organ, the Proportion of Patients for Whom the Organ is Identified by CT and CEUS as Injured (Regardless of Grade).
Description	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.
Time Frame	At the time the CEUS is performed, within 48 hours of injury.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liver	Spleen	Right Kidney	Left Kidney	Pancreas
Arm/Group Description	All subjects will have a liver injury identified by CT	All subjects will have a spleen injury identified by CT	All subjects will have a right kidney injury identified by CT	All subjects will have a left kidney injury identified by CT	All subjects will have a pancreas injury identified by CT
Measure Participants	23	40	9	12	1
Count of Participants [Participants]	16 21.6%	36 NaN	6 NaN	9 NaN	0 NaN

3. Secondary Outcome

Title	Proportion of Injuries Identified by CEUS Which Are Within 1 Grade of the Injury Identified by CT.
Description	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.
Time Frame	At the time the CEUS is performed, within 48 hours of injury.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liver	Spleen	Right Kidney	Left Kidney	Pancreas
Arm/Group Description	All subjects will have a liver injury identified by CT	All subjects will have a spleen injury identified by CT	All subjects will have a right kidney injury identified by CT	All subjects will have a left kidney injury identified by CT	All subjects will have a pancreas injury identified by CT
Measure Participants	23	40	9	12	1
Count of Participants [Participants]	11 14.9%	34 NaN	4 NaN	9 NaN	0 NaN

4. Secondary Outcome

Title	Proportion of Patients Where the Absence or Presence of Peritoneal Fluid Identified by CT is Also Identified by CEUS.
Description	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.
Time Frame	At the time the CEUS is performed, within 48 hours of injury.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CT-Fluid	CT-No Fluid
Arm/Group Description	All subjects will have fluid identified by CT	All subjects will have no fluid identified by CT
Measure Participants	55	19
Count of Participants [Participants]	42 56.8%	9 NaN

5. Secondary Outcome

Title	Proportion of Patients With Agreement Between 'Real-time' and Centralized Interpretation of CEUS Images.
Description	The contrast-enhanced ultrasounds will be re-read by a centralized reviewer and the results compared to those from the real-time reading.
Time Frame	At the time the CEUS is performed, within 48 hours of injury.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liver	Spleen	Right Kidney	Left Kidney	Pancreas	All Organs
Arm/Group Description	All subjects whose central review is complete	All subjects whose central review is complete	All subjects whose central review is complete	All subjects whose central review is complete	All subjects whose central review is complete	All subjects whose central review is complete
Measure Participants	68	68	68	68	68	68
Number [percentage of participants]	77.9 105.3%	72.1 NaN	88.2 NaN	95.6 NaN	98.5 NaN	44.1 NaN

Adverse Events

Time Frame	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.
Arm/Group Title	All Study Participants
Arm/Group Description	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.
All Cause Mortality
	All Study Participants
	Affected / at Risk (%)	# Events
Total	0/74 (0%)
Serious Adverse Events
	All Study Participants
	Affected / at Risk (%)	# Events
Total	0/74 (0%)
Other (Not Including Serious) Adverse Events
	All Study Participants
	Affected / at Risk (%)	# Events
Total	3/74 (4.1%)
Nervous system disorders
Dizziness	1/74 (1.4%)	1
Headache	1/74 (1.4%)	1
Skin and subcutaneous tissue disorders
Injection Site Reaction	1/74 (1.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.