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

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ClinicalTrials.gov Identifier: NCT03147690
Recruitment Status : Terminated (Stopped for futility)
First Posted : May 10, 2017
Results First Posted : December 10, 2020
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
David Mooney, Boston Children's Hospital

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.

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Study Type : Interventional  (Clinical Trial)
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 : November 1, 2017
Actual Primary Completion Date : October 7, 2019
Actual Study Completion Date : October 7, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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 Name: SonoVue




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. [ Time Frame: 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). [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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.



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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03147690


Locations
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United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
United States, California
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304
United States, Indiana
Riley Children's Health
Indianapolis, Indiana, United States, 45202
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
United States, Missouri
Children's Mercy Kansas City
Kansas City, Missouri, United States, 64108
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Nationwide Children's
Columbus, Ohio, United States, 43205
United States, Utah
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Sponsors and Collaborators
David Mooney
Investigators
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Principal Investigator: David Mooney, MD, MPH Boston Children's Hospital
  Study Documents (Full-Text)

Documents provided by David Mooney, Boston Children's Hospital:
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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    Key Record Dates
Results First Posted: December 10, 2020
Last Update Posted: June 11, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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, Boston Children's Hospital:
Solid Organ Injury
Additional relevant MeSH terms:
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Wounds and Injuries
Abdominal Injuries