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Effectiveness of Contrast-Enhanced Ultrasound

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ClinicalTrials.gov Identifier: NCT03473249
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : January 13, 2021
Sponsor:
Collaborator:
The Ray E. Helfer Society
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:
The purpose of the study is to generate pilot data describing test characteristics of contrast enhanced ultrasound in young children with concern for abdominal trauma. The primary objective in this study is to determine the sensitivity and specificity of contrast-enhanced ultrasound (CEUS) compared to abdominal Computed Tomography (CT) in the detection of abdominal solid organ injury in young children < 8 years of age with concern for blunt abdominal trauma.

Condition or disease Intervention/treatment Phase
Abdominal Injuries Physical Abuse Accidental Fall Motor Vehicle Injury Drug: Contrast-Enhanced Ultrasound using Lumason Phase 4

Detailed Description:

Abdominal trauma in children can be deadly, but intra-abdominal injuries can be difficult to detect and often lack external signs of injury on physical exam. The current gold standard imaging study is Computed Tomography (CT) with IV contrast, which is associated with radiation exposure. Contrast-enhanced ultrasound is a radiation-free alternative to detect abdominal injuries and has been studied primarily in adults and some older children, but evidence to support its use in young children is needed.

This is a prospective study of children less than 8 years of age who are clinically stable and undergoing an abdominal CT with IV contrast as part of their clinical care due to concerns for abdominal trauma. Investigators will compare CEUS results with those obtained by CT. Investigators will additionally include retrospective data of children who underwent both abdominal CT and CEUS as part of clinical care.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Effectiveness of Contrast-Enhanced Ultrasound in the Evaluation of Blunt Abdominal Trauma in Young Children
Actual Study Start Date : May 9, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Retrospective Review
Comparison of CT and CEUS results from retrospective chart review of children who have had a CEUS for trauma at the Children's Hospital of Philadelphia (CHOP).
No Intervention: Prospective Observation
Prospective observation of comparison of CT and CEUS results among children who are undergoing a CEUS and abdominal CT as part of clinical care.
Contrast-Enhanced Ultrasound using Lumason
Prospective intervention using contrast enhanced ultrasound with IV contrast Lumason.
Drug: Contrast-Enhanced Ultrasound using Lumason
Subjects will undergo a contrast enhanced ultrasound (CEUS) during which a standard greyscale abdominal ultrasound is performed first followed by injection of intravenous contrast with Lumason, and completion of contrast-enhanced ultrasound
Other Names:
  • SonoVue (25 mg under sulfur hexafluoride gas) / Lumason
  • Sulfur hexafluoride microbubbles for injection
  • US Patent No. 5,686,060




Primary Outcome Measures :
  1. Sensitivity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age [ Time Frame: 2 years ]
    To determine the sensitivity of contrast-enhanced ultrasound (CEUS) compared with standard, abdominal Computer Tomography (CT) in the detection of abdominal solid organ injury in young children < 8 years of age with concern for blunt abdominal trauma.

  2. Specificity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age [ Time Frame: 2 years ]
    To determine the specificity of contrast-enhanced ultrasound (CEUS) compared with standard, abdominal Computer Tomography (CT) in the detection of abdominal solid organ injury in young children < 8 years of age with concern for blunt abdominal trauma.



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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for study CEUS

  1. Males or females < 8 years of age at time of enrollment
  2. Clinically stable (defined as not undergoing an emergent surgical procedure in the next hour)
  3. Abdominal CT ordered or obtained
  4. IV in place

Exclusion Criteria for study CEUS

  1. Unable to obtain contrast-enhanced ultrasound within 72 hours after CT
  2. History of allergic reaction to Lumason, sulfa-hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na) palmitic acid)
  3. Known congenital or acquired heart disease

Alternative Inclusion and Exclusion Criteria for children who have undergone or are undergoing CEUS as part of clinical care

Inclusion criteria:

  1. Males or females < 8 years of age at time of CEUS.
  2. Clinical Team plans to perform CT or has performed CT as part of clinical care for abdominal trauma
  3. Clinical Team plans to perform (or has performed) CEUS as part of clinical care
  4. Date of CEUS after January 1, 2015

Exclusion Criteria: None


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): NCT03473249


Contacts
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Contact: Kate Henry, MD, MSCE 215-590-2351 henrym2@email.chop.edu

Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kate Henry, MD, MSCE    215-531-2514    henrym2@email.chop.edu   
Contact: Joanne Wood, MD, MSHP    (267) 426-3107    woodjo@email.chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
The Ray E. Helfer Society
Publications:

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03473249    
Other Study ID Numbers: 17-014183
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 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
Additional relevant MeSH terms:
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Wounds and Injuries
Abdominal Injuries