NCT03490929

Brief Summary

Children with blunt abdominal trauma often get a CT as the first line imaging to evaluate for intra-abdominal organ injury. CT scans have some downsides with regard to radiation exposure, costs, and need for transport. Contrast enhanced ultrasonography has recently shown some promise as a way to detect intra-abdominal organ injury and may be able to replace the need for conventional CT scanning, without the need for ionizing radiation and the ability to be performed at the bedside.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for phase_4

Timeline
8mo left

Started Jun 2018

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Jun 2018Dec 2026

First Submitted

Initial submission to the registry

March 23, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 6, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

8.6 years

First QC Date

March 23, 2018

Last Update Submit

December 16, 2025

Conditions

Trauma Abdomen

Outcome Measures

Primary Outcomes (2)

  • Sensitivity of CEUS

    calculation of sensitivity of CEUS for organ injury, as compared to gold standard CT

    through study completion, which is expected to take around 3 years

  • Specificity of CEUS

    calculation of specificity of CEUS for organ injury, as compared to gold standard CT exam

    through study completion, which is expected to take around 3 years

Study Arms (1)

Contrast-enhanced ultrasound arm

EXPERIMENTAL

contrast-enhanced ultrasound

Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON]Device: contrast-enhanced ultrasound

Interventions

contrast-enhanced ultrasoundDEVICE

ultrasound of the abdomen after injection of ultrasound contrast agent (Lumason)

Also known as: ultrasound
Contrast-enhanced ultrasound arm
Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON]DRUG

injection of Lumason (ultrasound contrast agent)

Also known as: Lumason
Contrast-enhanced ultrasound arm

Eligibility Criteria

Age0 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Hemodynamically stable (defined as not needing massive transfusion protocol and not undergoing an emergent surgical procedure within the next hour)
  • History of or suspicion for blunt abdominal trauma
  • Abdominal CT ordered or obtained

You may not qualify if:

  • History of allergic reaction to Lumason, sulfur hexaflouride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), palmitic acid)
  • Co-existing penetrating abdominal trauma
  • Known congenital or acquired heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55902, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

RECRUITING

Related Publications (16)

  • Armstrong LB, Mooney DP, Paltiel H, Barnewolt C, Dionigi B, Arbuthnot M, Onwubiko C, Connolly SA, Jarrett DY, Zalieckas JM. Contrast enhanced ultrasound for the evaluation of blunt pediatric abdominal trauma. J Pediatr Surg. 2018 Mar;53(3):548-552. doi: 10.1016/j.jpedsurg.2017.03.042. Epub 2017 Mar 20.

    PMID: 28351519BACKGROUND

  • Miele V, Piccolo CL, Galluzzo M, Ianniello S, Sessa B, Trinci M. Contrast-enhanced ultrasound (CEUS) in blunt abdominal trauma. Br J Radiol. 2016;89(1061):20150823. doi: 10.1259/bjr.20150823. Epub 2016 Jan 8.

    PMID: 26607647BACKGROUND

  • Menichini G, Sessa B, Trinci M, Galluzzo M, Miele V. Accuracy of contrast-enhanced ultrasound (CEUS) in the identification and characterization of traumatic solid organ lesions in children: a retrospective comparison with baseline US and CE-MDCT. Radiol Med. 2015 Nov;120(11):989-1001. doi: 10.1007/s11547-015-0535-z. Epub 2015 Mar 31.

    PMID: 25822953BACKGROUND

  • Cagini L, Gravante S, Malaspina CM, Cesarano E, Giganti M, Rebonato A, Fonio P, Scialpi M. Contrast enhanced ultrasound (CEUS) in blunt abdominal trauma. Crit Ultrasound J. 2013 Jul 15;5 Suppl 1(Suppl 1):S9. doi: 10.1186/2036-7902-5-S1-S9. Epub 2013 Jul 15.

    PMID: 23902930BACKGROUND

  • Cokkinos D, Antypa E, Stefanidis K, Tserotas P, Kostaras V, Parlamenti A, Tavernaraki K, Piperopoulos PN. Contrast-enhanced ultrasound for imaging blunt abdominal trauma - indications, description of the technique and imaging review. Ultraschall Med. 2012 Feb;33(1):60-7. doi: 10.1055/s-0031-1273442. Epub 2012 Jan 24.

    PMID: 22274907BACKGROUND

  • Afaq A, Harvey C, Aldin Z, Leen E, Cosgrove D. Contrast-enhanced ultrasound in abdominal trauma. Eur J Emerg Med. 2012 Jun;19(3):140-5. doi: 10.1097/MEJ.0b013e328348c980.

    PMID: 21934507BACKGROUND

  • Valentino M, De Luca C, Galloni SS, Branchini M, Modolon C, Pavlica P, Barozzi L. Contrast-enhanced US evaluation in patients with blunt abdominal trauma(). J Ultrasound. 2010 Mar;13(1):22-7. doi: 10.1016/j.jus.2010.06.002. Epub 2010 Jul 8.

    PMID: 23396012BACKGROUND

  • Valentino M, Ansaloni L, Catena F, Pavlica P, Pinna AD, Barozzi L. Contrast-enhanced ultrasonography in blunt abdominal trauma: considerations after 5 years of experience. Radiol Med. 2009 Oct;114(7):1080-93. doi: 10.1007/s11547-009-0444-0. Epub 2009 Sep 22.

    PMID: 19774445BACKGROUND

  • Sivit CJ. Imaging children with abdominal trauma. AJR Am J Roentgenol. 2009 May;192(5):1179-89. doi: 10.2214/AJR.08.2163.

    PMID: 19380540BACKGROUND

  • Catalano O, Aiani L, Barozzi L, Bokor D, De Marchi A, Faletti C, Maggioni F, Montanari N, Orlandi PE, Siani A, Sidhu PS, Thompson PK, Valentino M, Ziosi A, Martegani A. CEUS in abdominal trauma: multi-center study. Abdom Imaging. 2009 Mar-Apr;34(2):225-34. doi: 10.1007/s00261-008-9452-0.

    PMID: 18682877BACKGROUND

  • Clevert DA, Weckbach S, Minaifar N, Clevert DA, Stickel M, Reiser M. Contrast-enhanced ultrasound versus MS-CT in blunt abdominal trauma. Clin Hemorheol Microcirc. 2008;39(1-4):155-69.

    PMID: 18503121BACKGROUND

  • Valentino M, Serra C, Pavlica P, Labate AM, Lima M, Baroncini S, Barozzi L. Blunt abdominal trauma: diagnostic performance of contrast-enhanced US in children--initial experience. Radiology. 2008 Mar;246(3):903-9. doi: 10.1148/radiol.2463070652. Epub 2008 Jan 14.

    PMID: 18195385BACKGROUND

  • Bixby SD, Callahan MJ, Taylor GA. Imaging in pediatric blunt abdominal trauma. Semin Roentgenol. 2008 Jan;43(1):72-82. doi: 10.1053/j.ro.2007.08.009. No abstract available.

    PMID: 18053830BACKGROUND

  • Ntoulia A, Anupindi SA, Darge K, Back SJ. Applications of contrast-enhanced ultrasound in the pediatric abdomen. Abdom Radiol (NY). 2018 Apr;43(4):948-959. doi: 10.1007/s00261-017-1315-0.

    PMID: 28980061BACKGROUND

  • Darge K, Papadopoulou F, Ntoulia A, Bulas DI, Coley BD, Fordham LA, Paltiel HJ, McCarville B, Volberg FM, Cosgrove DO, Goldberg BB, Wilson SR, Feinstein SB. Safety of contrast-enhanced ultrasound in children for non-cardiac applications: a review by the Society for Pediatric Radiology (SPR) and the International Contrast Ultrasound Society (ICUS). Pediatr Radiol. 2013 Sep;43(9):1063-73. doi: 10.1007/s00247-013-2746-6. Epub 2013 Jul 11.

    PMID: 23843130BACKGROUND

  • Parker JM, Weller MW, Feinstein LM, Adams RJ, Main ML, Grayburn PA, Cosgrove DO, Goldberg BA, Darge K, Nihoyannopoulos P, Wilson S, Monaghan M, Piscaglia F, Fowlkes B, Mathias W, Moriyasu F, Chammas MC, Greenbaum L, Feinstein SB. Safety of ultrasound contrast agents in patients with known or suspected cardiac shunts. Am J Cardiol. 2013 Oct 1;112(7):1039-45. doi: 10.1016/j.amjcard.2013.05.042. Epub 2013 Jun 28.

    PMID: 23816393BACKGROUND

MeSH Terms

Conditions

Abdominal Injuries

Interventions

SuspensionsUltrasonography

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical PreparationsDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Aaron E Chen, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aaron E Chen, MD

CONTACT

2674260383chena2@chop.edu

Rachel Rempell, MD

CONTACT

2155907041rempellr@chop.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Pediatrics

Study Record Dates

First Submitted

March 23, 2018

First Posted

April 6, 2018

Study Start

June 1, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 17, 2025

Record last verified: 2025-12

Locations

US(2)