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

Primary Purpose

Abdominal Injury

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lumason
Sponsored by
David Mooney
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Abdominal Injury focused on measuring Solid Organ Injury

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Phoenix Children's Hospital
  • Lucile Packard Children's Hospital
  • Riley Children's Health
  • Boston Children's Hospital
  • Children's Mercy Kansas City
  • Cincinnati Children's Hospital Medical Center
  • Nationwide Children's
  • Primary Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Study Participants

Arm 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
April 27, 2017
Last Updated
June 3, 2021
Sponsor
David Mooney
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1. Study Identification

Unique Protocol Identification Number
NCT03147690
Brief Title
Contrast-Enhanced Ultrasound in the Evaluation of Abdominal Injuries in Children
Official Title
A Multicenter Trial of Contrast-Enhanced Ultrasound in the Evaluation of Abdominal Solid Organ Injuries in Pediatric Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Stopped for futility
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
October 7, 2019 (Actual)
Study Completion Date
October 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Mooney

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Injury
Keywords
Solid Organ Injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All Study Participants
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Lumason
Other Intervention Name(s)
SonoVue
Intervention Description
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.
Primary Outcome Measure Information:
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.
Secondary Outcome Measure Information:
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.
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.
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Mooney, MD, MPH
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Lucile Packard Children's Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Riley Children's Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
45202
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Children's Mercy Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Nationwide Children's
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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