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
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Injuries Physical Abuse Accidental Fall Motor Vehicle Injury||Drug: Contrast-Enhanced Ultrasound using Lumason||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
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
|Contact: Kate Henry, MD, MSCEfirstname.lastname@example.org|