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Contrast Ultrasound for Pediatric Trauma - Comparative Evaluation (CAPTURE Study)

Primary Purpose

Abdominal Injury

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lumason
Sponsored by
David Mooney
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Abdominal Injury focused on measuring Solid Organ Injury

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Hemodynamically stable, as determined by the trauma team
  2. Age 8 through 18 years (inclusive)
  3. Interpretable CT of the abdomen and pelvis that demonstrates at least one solid organ injury among the liver, spleen, pancreas, and kidneys
  4. Plan for observation or admission to the hospital
  5. Candidate for abdominal ultrasound based on body habitus, as determined by the investigator
  6. Glasgow Coma Score of 15
  7. Able to complete the study procedures within 48 hours of injury

Exclusion Criteria:

  1. Known cardiac abnormality
  2. Pulmonary Hypertension
  3. Known sensitivity to any Lumason components - including sulfur hexafluoride, polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), or palmitic acid
  4. Unable to be rolled onto side to allow lateral ultrasound windows if necessary
  5. Unable to assent or consent
  6. Pregnant
  7. Lactating
  8. CT images not available for transmission to central image repository

Sites / Locations

  • Phoenix Children's HospitalRecruiting
  • Boston Children's HospitalRecruiting
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • University of Texas Southwestern Medical Center
  • University of Utah

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Study Participants

Arm Description

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

Outcomes

Primary Outcome Measures

Overall CEUS/CT Concordance for all study participants
A patient is classified as having a "concordant" assessment if each organ identified by CT with injuries is exactly identified by CEUS, regardless of injury grade, by the local study site reviewer. Otherwise, a patient is classified as having a "discordant" assessment.

Secondary Outcome Measures

Organ-specific CEUS/CT Concordance
For each organ, a patient's organ is classified as having a "concordant" assessment if the presence or absence of an injury as identified by CT is exactly identified by CEUS. Otherwise, a patient is classified as having a "discordant" assessment.
Grade-specific Overall CEUS/CT Concordance
A patient is classified as having a "concordant" assessment if each organ identified by CT with injuries is exactly identified by CEUS, AND within 1 grade of the injury as identified by CT. Otherwise, a patient is classified as having a "discordant" assessment.
Peritoneal Fluid CEUS/CT Concordance
A patient is classified as having a "concordant" assessment if the absence or presence of peritoneal fluid identified by CT is also exactly identified by CEUS. Otherwise, a patient is classified as having a "discordant" assessment.
Real-time/Centralized CEUS Concordance
A patient is classified as having a "concordant" assessment if the absence or presence of injury for each organ identified by 'real-time' CEUS with injuries is also exactly identified by centralized interpretation of CEUS images.

Full Information

First Posted
January 16, 2021
Last Updated
September 10, 2023
Sponsor
David Mooney
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1. Study Identification

Unique Protocol Identification Number
NCT04718441
Brief Title
Contrast Ultrasound for Pediatric Trauma - Comparative Evaluation (CAPTURE Study)
Official Title
Contrast Ultrasound for Pediatric Trauma - Comparative Evaluation (CAPTURE Study)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Mooney

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
Yes

5. Study Description

Brief Summary
This multicenter study aims to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric patients. Up to 130 subjects will complete the study across approximately 5-10 sites in the US, with up to 30 patients in the training phase (3 per site) and 100 patients in the treatment phase of the study. All subjects will have had a CT scan as part of standard of care, confirming at least one solid organ abdominal injury. The study procedure will occur within 48 hours from time of 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 CT and ultrasound scans will be read locally and will undergo central review.
Detailed Description
This is an interventional study which proposes to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric trauma patients. Up to 130 subjects will be enrolled across approximately 5 to 10 sites in the US. Each site, including the coordinating center, will undergo the training phase; each site will enroll 3 participants in this phase successfully prior to entering the treatment phase. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Injury
Keywords
Solid Organ Injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All Study Participants
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Lumason
Other Intervention Name(s)
SonoVue
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall CEUS/CT Concordance for all study participants
Description
A patient is classified as having a "concordant" assessment if each organ identified by CT with injuries is exactly identified by CEUS, regardless of injury grade, by the local study site reviewer. Otherwise, a patient is classified as having a "discordant" assessment.
Time Frame
At the time the CEUS is performed, within 48 hours of injury
Secondary Outcome Measure Information:
Title
Organ-specific CEUS/CT Concordance
Description
For each organ, a patient's organ is classified as having a "concordant" assessment if the presence or absence of an injury as identified by CT is exactly identified by CEUS. Otherwise, a patient is classified as having a "discordant" assessment.
Time Frame
At the time the CEUS is performed, within 48 hours of injury
Title
Grade-specific Overall CEUS/CT Concordance
Description
A patient is classified as having a "concordant" assessment if each organ identified by CT with injuries is exactly identified by CEUS, AND within 1 grade of the injury as identified by CT. Otherwise, a patient is classified as having a "discordant" assessment.
Time Frame
At the time the CEUS is performed, within 48 hours of injury
Title
Peritoneal Fluid CEUS/CT Concordance
Description
A patient is classified as having a "concordant" assessment if the absence or presence of peritoneal fluid identified by CT is also exactly identified by CEUS. Otherwise, a patient is classified as having a "discordant" assessment.
Time Frame
At the time the CEUS is performed, within 48 hours of injury.
Title
Real-time/Centralized CEUS Concordance
Description
A patient is classified as having a "concordant" assessment if the absence or presence of injury for each organ identified by 'real-time' CEUS with injuries is also exactly identified by centralized interpretation of CEUS images.
Time Frame
At the time the CEUS is performed, within 48 hours of injury.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hemodynamically stable, as determined by the trauma team Age 8 through 18 years (inclusive) Interpretable CT of the abdomen and pelvis that demonstrates at least one 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, as determined by the investigator 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 any Lumason components - including sulfur hexafluoride, polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), or palmitic acid Unable to be rolled onto side to allow lateral ultrasound windows if necessary Unable to assent or consent Pregnant Lactating CT images not available for transmission to central image repository
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Crethers
Phone
617-919-6325
Email
Danielle.crethers@childrens.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Samarpita Chatterjee
Email
samarpita.chatterjee@childrens.harvard.edukathy.wong@childrens.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Mooney, MD, MPH
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Garvey, MD
Phone
602-933-0016
Email
egarvey@phoenixchildrens.com
First Name & Middle Initial & Last Name & Degree
Erin Garvey, MD
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Crethers
Phone
617-919-6325
Email
Danielle.crethers@childrens.harvard.edu
First Name & Middle Initial & Last Name & Degree
David Mooney, MD, MPH
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Moody, MPA
Phone
513-636-8639
Email
Suzanne.Moody@cchmc.org
First Name & Middle Initial & Last Name & Degree
Richard Falcone, MD
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Starcke, B.S.
Phone
214-648-7754
Email
Charlton.Starcke@UTSouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Jeannie Kwon, MD
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kezlyn Larsen
Phone
801-662-2989
Email
kezlyn.larsen@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Katie Russell, MD

12. IPD Sharing Statement

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Contrast Ultrasound for Pediatric Trauma - Comparative Evaluation (CAPTURE Study)

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