Clinical trial NCT03147690: 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
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Abdominal Injury
Keywords: Solid Organ Injury
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 74
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Proportion of Patients for Whom All Organs Identified by CT With Injuries Are Also Identified by CEUS, Regardless of Injury Grade.
timeFrame: At the time the CEUS is performed, within 48 hours of injury.
Secondary outcomes:
measure: For Each Organ, the Proportion of Patients for Whom the Organ is Identified by CT and CEUS as Injured (Regardless of Grade).
timeFrame: At the time the CEUS is performed, within 48 hours of injury.
measure: Proportion of Injuries Identified by CEUS Which Are Within 1 Grade of the Injury Identified by CT.
timeFrame: At the time the CEUS is performed, within 48 hours of injury.
measure: Proportion of Patients Where the Absence or Presence of Peritoneal Fluid Identified by CT is Also Identified by CEUS.
timeFrame: At the time the CEUS is performed, within 48 hours of injury.
measure: Proportion of Patients With Agreement Between 'Real-time' and Centralized Interpretation of CEUS Images.
timeFrame: At the time the CEUS is performed, within 48 hours of injury.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital
state: California
city: Indianapolis
country: United States
facility: Riley Children's Health
state: Indiana
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Kansas City
country: United States
facility: Children's Mercy Kansas City
state: Missouri
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's
state: Ohio
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
Study officials:
affiliation: Boston Children's Hospital
name: David Mooney, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: