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Effectiveness of Contrast-Enhanced Ultrasound

Primary Purpose

Abdominal Injuries, Physical Abuse, Accidental Fall

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Contrast-Enhanced Ultrasound using Lumason
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Abdominal Injuries

Eligibility Criteria

0 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Other

Arm Label

Retrospective Review

Prospective Observation

Contrast-Enhanced Ultrasound using Lumason

Arm Description

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).

Prospective observation of comparison of CT and CEUS results among children who are undergoing a CEUS and abdominal CT as part of clinical care.

Prospective intervention using contrast enhanced ultrasound with IV contrast Lumason.

Outcomes

Primary Outcome Measures

Sensitivity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age
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.
Specificity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age
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.

Secondary Outcome Measures

Full Information

First Posted
March 15, 2018
Last Updated
January 3, 2023
Sponsor
Children's Hospital of Philadelphia
Collaborators
The Ray E. Helfer Society
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1. Study Identification

Unique Protocol Identification Number
NCT03473249
Brief Title
Effectiveness of Contrast-Enhanced Ultrasound
Official Title
Clinical Effectiveness of Contrast-Enhanced Ultrasound in the Evaluation of Blunt Abdominal Trauma in Young Children
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 9, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
The Ray E. Helfer Society

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
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Injuries, Physical Abuse, Accidental Fall, Motor Vehicle Injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Retrospective Review
Arm Type
No Intervention
Arm Description
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).
Arm Title
Prospective Observation
Arm Type
No Intervention
Arm Description
Prospective observation of comparison of CT and CEUS results among children who are undergoing a CEUS and abdominal CT as part of clinical care.
Arm Title
Contrast-Enhanced Ultrasound using Lumason
Arm Type
Other
Arm Description
Prospective intervention using contrast enhanced ultrasound with IV contrast Lumason.
Intervention Type
Drug
Intervention Name(s)
Contrast-Enhanced Ultrasound using Lumason
Other Intervention Name(s)
SonoVue (25 mg under sulfur hexafluoride gas) / Lumason, Sulfur hexafluoride microbubbles for injection, US Patent No. 5,686,060
Intervention Description
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
Primary Outcome Measure Information:
Title
Sensitivity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age
Description
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.
Time Frame
2 years
Title
Specificity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for study CEUS Males or females < 8 years of age at time of enrollment Clinically stable (defined as not undergoing an emergent surgical procedure in the next hour) Abdominal CT ordered or obtained IV in place Exclusion Criteria for study CEUS Unable to obtain contrast-enhanced ultrasound within 72 hours after CT 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) 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: Males or females < 8 years of age at time of CEUS. Clinical Team plans to perform CT or has performed CT as part of clinical care for abdominal trauma Clinical Team plans to perform (or has performed) CEUS as part of clinical care Date of CEUS after January 1, 2015 Exclusion Criteria: None
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Effectiveness of Contrast-Enhanced Ultrasound

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