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

NCT03147690 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: P00025242
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 8

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.

Conditions

Abdominal Injury

Keywords

Solid Organ Injury

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients for Whom All Organs Identified by CT With Injuries Are Also Identified by CEUS, Regardless of Injury Grade.

  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.

  At the time the CEUS is performed, within 48 hours of injury.

Secondary Outcomes (4)

• For Each Organ, the Proportion of Patients for Whom the Organ is Identified by CT and CEUS as Injured (Regardless of Grade).

  At the time the CEUS is performed, within 48 hours of injury.

• Proportion of Injuries Identified by CEUS Which Are Within 1 Grade of the Injury Identified by CT.

  At the time the CEUS is performed, within 48 hours of injury.

• Proportion of Patients Where the Absence or Presence of Peritoneal Fluid Identified by CT is Also Identified by CEUS.

  At the time the CEUS is performed, within 48 hours of injury.

• Proportion of Patients With Agreement Between 'Real-time' and Centralized Interpretation of CEUS Images.

  At the time the CEUS is performed, within 48 hours of injury.

Study Arms (1)

All Study Participants

EXPERIMENTAL

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

Interventions

Lumason DRUG

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.

Also known as: SonoVue

All Study Participants

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• David Mooney: lead

Study Sites (8)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

Riley Children's Health

Indianapolis, Indiana, 45202, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Nationwide Children's

Columbus, Ohio, 43205, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

MeSH Terms

Conditions

Abdominal Injuries

Interventions

contrast agent BR1

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Dr. David Mooney, MD MPH
• Organization: Boston Children's Hospital

david.mooney@childrens.harvard.edu

617-355-7800

Study Officials

• David Mooney, MD, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Trauma Program

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 10, 2017
• Study Start: November 1, 2017
• Primary Completion: October 7, 2019
• Study Completion: October 7, 2019
• Last Updated: June 11, 2021
• Results First Posted: December 10, 2020

Record last verified: 2021-06

Locations

US (8)