Abdominal InjuriesPhase 4NCT03473249

Effectiveness of Contrast-Enhanced Ultrasound

A Phase 4 study testing Contrast-Enhanced Ultrasound using Lumason in people with Abdominal Injuries and Physical Abuse, run by Children's Hospital of Philadelphia at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The purpose of the study is to generate pilot data describing test characteristics of contrast enhanced ultrasound in young children with concern for abdominal trauma. The primary objective in this study is to determine the sensitivity and specificity of contrast-enhanced ultrasound (CEUS) compared to abdominal… Read more about this study

Who is it for?: Ages 0 to 7 yearsHealthy volunteers can take part
Conditions the study is for: Abdominal Injuries, Physical Abuse, Accidental Fall
What is being tested?: Contrast-Enhanced Ultrasound using Lumason
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteUnited States
Study dates: 9 May 2018to Dec 2026
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 0 to 7 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Males or females < 8 years of age at time of enrollment
Clinically stable (defined as not undergoing an emergent surgical procedure in the next hour)
Abdominal CT ordered or obtained
IV in place
Males or females < 8 years of age at time of CEUS.
Clinical Team plans to perform CT or has performed CT as part of clinical care for abdominal trauma
Clinical Team plans to perform (or has performed) CEUS as part of clinical care
Date of CEUS after January 1, 2015

Who cannot join

Unable to obtain contrast-enhanced ultrasound within 72 hours after CT
History of allergic reaction to Lumason, sulfa-hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na) palmitic acid)
Known congenital or acquired heart disease
Alternative Inclusion and Exclusion Criteria for children who have undergone or are undergoing CEUS as part of clinical care

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Clinical Effectiveness of Contrast-Enhanced Ultrasound in the Evaluation of Blunt Abdominal Trauma in Young Children

Read the detailed description

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.

Conditions: Abdominal Injuries, Physical Abuse, Accidental Fall, Motor Vehicle Injury
Being tested: Contrast-Enhanced Ultrasound using Lumason
Medical subject headings: Abdominal Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Contrast-Enhanced Ultrasound using LumasonDrug
Also called SonoVue (25 mg under sulfur hexafluoride gas) / Lumason, Sulfur hexafluoride microbubbles for injection, US Patent No. 5,686,060
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

Study groups in NCT03473249
Study group	Role	What they receive
Retrospective Review	No intervention	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).
Prospective Observation	No intervention	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	Other	Prospective intervention using contrast enhanced ultrasound with IV contrast Lumason. Receives: Drug: Contrast-Enhanced Ultrasound using Lumason

What is being measured

The primary outcome is the main question the study is designed to answer.

Sensitivity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age
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.
Measured: 2 years
Specificity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age
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.
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 May 2018Dec 2026

First posted22 Mar 2018
Study start9 May 2018
Primary completionDec 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (29)Papers the sponsor has linked to this study.
Other trials for Abdominal InjuriesStudies of the same condition, open and under way.
More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03473249
Sponsor's protocol ID: 17-014183
Status last verified: Dec 2025
First submitted: 15 Mar 2018
Last updated: 24 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Wood J, Rubin DM, Nance ML, Christian CW. Distinguishing inflicted versus accidental abdominal injuries in young children. J Trauma. 2005 Nov;59(5):1203-8. doi: 10.1097/01.ta.0000196437.07011.b1.
PubMed 16385300
Lutz N, Nance ML, Kallan MJ, Arbogast KB, Durbin DR, Winston FK. Incidence and clinical significance of abdominal wall bruising in restrained children involved in motor vehicle crashes. J Pediatr Surg. 2004 Jun;39(6):972-5. doi: 10.1016/j.jpedsurg.2004.02.029.
PubMed 15185237
Carter KW, Moulton SL. Pediatric abdominal injury patterns caused by "falls": A comparison between nonaccidental and accidental trauma. J Pediatr Surg. 2016 Feb;51(2):326-8. doi: 10.1016/j.jpedsurg.2015.10.056. Epub 2015 Oct 31.
PubMed 26850907
Cooper A, Floyd T, Barlow B, Niemirska M, Ludwig S, Seidl T, O'Neill J, Templeton J, Ziegler M, Ross A, et al. Major blunt abdominal trauma due to child abuse. J Trauma. 1988 Oct;28(10):1483-7. doi: 10.1097/00005373-198810000-00015.
PubMed 3172310
Lindberg D, Makoroff K, Harper N, Laskey A, Bechtel K, Deye K, Shapiro R; ULTRA Investigators. Utility of hepatic transaminases to recognize abuse in children. Pediatrics. 2009 Aug;124(2):509-16. doi: 10.1542/peds.2008-2348. Epub 2009 Jul 20.
PubMed 19620197
Lindberg DM, Shapiro RA, Blood EA, Steiner RD, Berger RP; ExSTRA investigators. Utility of hepatic transaminases in children with concern for abuse. Pediatrics. 2013 Feb;131(2):268-75. doi: 10.1542/peds.2012-1952. Epub 2013 Jan 14.
PubMed 23319537
Trout AT, Strouse PJ, Mohr BA, Khalatbari S, Myles JD. Abdominal and pelvic CT in cases of suspected abuse: can clinical and laboratory findings guide its use? Pediatr Radiol. 2011 Jan;41(1):92-8. doi: 10.1007/s00247-010-1847-8. Epub 2010 Oct 9.
PubMed 20936274
Hennes HM, Smith DS, Schneider K, Hegenbarth MA, Duma MA, Jona JZ. Elevated liver transaminase levels in children with blunt abdominal trauma: a predictor of liver injury. Pediatrics. 1990 Jul;86(1):87-90.
PubMed 2359686
Rothrock SG, Green SM, Morgan R. Abdominal trauma in infants and children: prompt identification and early management of serious and life-threatening injuries. Part I: injury patterns and initial assessment. Pediatr Emerg Care. 2000 Apr;16(2):106-15. doi: 10.1097/00006565-200004000-00012.
PubMed 10784214
Goske MJ, Applegate KE, Bulas D, Butler PF, Callahan MJ, Coley BD, Don S, Frush DP, Hernanz-Schulman M, Kaste SC, Morrison G, Sidhu M, Strauss KJ, Treves ST; Alliance for Radiation Safety in Pediatric Imaging. Image Gently: progress and challenges in CT education and advocacy. Pediatr Radiol. 2011 Sep;41 Suppl 2:461-6. doi: 10.1007/s00247-011-2133-0. Epub 2011 Aug 17.
PubMed 21847723
Laugesen NG, Nolsoe CP, Rosenberg J. Clinical Applications of Contrast-Enhanced Ultrasound in the Pediatric Work-Up of Focal Liver Lesions and Blunt Abdominal Trauma: A Systematic Review. Ultrasound Int Open. 2017 Feb;3(1):E2-E7. doi: 10.1055/s-0042-124502.
PubMed 28255580
Miele V, Piccolo CL, Trinci M, Galluzzo M, Ianniello S, Brunese L. Diagnostic imaging of blunt abdominal trauma in pediatric patients. Radiol Med. 2016 May;121(5):409-30. doi: 10.1007/s11547-016-0637-2. Epub 2016 Apr 13.
PubMed 27075018
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.
PubMed 18682877
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.
PubMed 18503121
Manetta R, Pistoia ML, Bultrini C, Stavroulis E, Di Cesare E, Masciocchi C. Ultrasound enhanced with sulphur-hexafluoride-filled microbubbles agent (SonoVue) in the follow-up of mild liver and spleen trauma. Radiol Med. 2009 Aug;114(5):771-9. doi: 10.1007/s11547-009-0406-6. Epub 2009 May 30. English, Italian.
PubMed 19484583

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Effectiveness of Contrast-Enhanced Ultrasound in the Evaluation of Blunt Abdominal Trauma in Young Children
ClinicalTrials.gov ID: NCT03473249
Acronym / sponsor ID: 17-014183
Conditions: Abdominal Injuries, Physical Abuse, Accidental Fall, Motor Vehicle Injury
Phase: Phase 4
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 120 participants (estimated)
Lead sponsor: Children's Hospital of PhiladelphiaUniversity, hospital or other
Study start: 9 May 2018 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2026 (estimated)
First posted: 22 Mar 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Retrospective Review	No intervention	–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).
Prospective Observation	No intervention	–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	Other	Drug: Contrast-Enhanced Ultrasound using LumasonProspective intervention using contrast enhanced ultrasound with IV contrast Lumason.

Who may qualify

Ages: 0 to 7 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (8 listed)

Males or females < 8 years of age at time of enrollment
Clinically stable (defined as not undergoing an emergent surgical procedure in the next hour)
Abdominal CT ordered or obtained
IV in place
Males or females < 8 years of age at time of CEUS.

Key exclusion criteria (4 listed)

Unable to obtain contrast-enhanced ultrasound within 72 hours after CT
History of allergic reaction to Lumason, sulfa-hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na) palmitic acid)
Known congenital or acquired heart disease
Alternative Inclusion and Exclusion Criteria for children who have undergone or are undergoing CEUS as part of clinical care

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Contrast-Enhanced Ultrasound using LumasonAlso: SonoVue (25 mg under sulfur hexafluoride gas) / Lumason, Sulfur hexafluoride microbubbles for injection, US Patent No. 5,686,060Subjects 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	Drug	Contrast-Enhanced Ultrasound using Lumason

Primary outcome

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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
Background: PubMed 16385300Wood J, Rubin DM, Nance ML, Christian CW. Distinguishing inflicted versus accidental abdominal injuries in young children. J Trauma. 2005 Nov;59(5):1203-8. doi: 10.1097/01.ta.0000196437.07011.b1.
Background: PubMed 15185237Lutz N, Nance ML, Kallan MJ, Arbogast KB, Durbin DR, Winston FK. Incidence and clinical significance of abdominal wall bruising in restrained children involved in motor vehicle crashes. J Pediatr Surg. 2004 Jun;39(6):972-5. doi: 10.1016/j.jpedsurg.2004.02.029.
Background: PubMed 26850907Carter KW, Moulton SL. Pediatric abdominal injury patterns caused by "falls": A comparison between nonaccidental and accidental trauma. J Pediatr Surg. 2016 Feb;51(2):326-8. doi: 10.1016/j.jpedsurg.2015.10.056. Epub 2015 Oct 31.
Background: PubMed 3172310Cooper A, Floyd T, Barlow B, Niemirska M, Ludwig S, Seidl T, O'Neill J, Templeton J, Ziegler M, Ross A, et al. Major blunt abdominal trauma due to child abuse. J Trauma. 1988 Oct;28(10):1483-7. doi: 10.1097/00005373-198810000-00015.
Background: PubMed 19620197Lindberg D, Makoroff K, Harper N, Laskey A, Bechtel K, Deye K, Shapiro R; ULTRA Investigators. Utility of hepatic transaminases to recognize abuse in children. Pediatrics. 2009 Aug;124(2):509-16. doi: 10.1542/peds.2008-2348. Epub 2009 Jul 20.
Background: PubMed 23319537Lindberg DM, Shapiro RA, Blood EA, Steiner RD, Berger RP; ExSTRA investigators. Utility of hepatic transaminases in children with concern for abuse. Pediatrics. 2013 Feb;131(2):268-75. doi: 10.1542/peds.2012-1952. Epub 2013 Jan 14.
Background: PubMed 20936274Trout AT, Strouse PJ, Mohr BA, Khalatbari S, Myles JD. Abdominal and pelvic CT in cases of suspected abuse: can clinical and laboratory findings guide its use? Pediatr Radiol. 2011 Jan;41(1):92-8. doi: 10.1007/s00247-010-1847-8. Epub 2010 Oct 9.
Background: PubMed 2359686Hennes HM, Smith DS, Schneider K, Hegenbarth MA, Duma MA, Jona JZ. Elevated liver transaminase levels in children with blunt abdominal trauma: a predictor of liver injury. Pediatrics. 1990 Jul;86(1):87-90.
Background: PubMed 10784214Rothrock SG, Green SM, Morgan R. Abdominal trauma in infants and children: prompt identification and early management of serious and life-threatening injuries. Part I: injury patterns and initial assessment. Pediatr Emerg Care. 2000 Apr;16(2):106-15. doi: 10.1097/00006565-200004000-00012.
Background: PubMed 21847723Goske MJ, Applegate KE, Bulas D, Butler PF, Callahan MJ, Coley BD, Don S, Frush DP, Hernanz-Schulman M, Kaste SC, Morrison G, Sidhu M, Strauss KJ, Treves ST; Alliance for Radiation Safety in Pediatric Imaging. Image Gently: progress and challenges in CT education and advocacy. Pediatr Radiol. 2011 Sep;41 Suppl 2:461-6. doi: 10.1007/s00247-011-2133-0. Epub 2011 Aug 17.
Background: PubMed 28255580Laugesen NG, Nolsoe CP, Rosenberg J. Clinical Applications of Contrast-Enhanced Ultrasound in the Pediatric Work-Up of Focal Liver Lesions and Blunt Abdominal Trauma: A Systematic Review. Ultrasound Int Open. 2017 Feb;3(1):E2-E7. doi: 10.1055/s-0042-124502.
Background: PubMed 27075018Miele V, Piccolo CL, Trinci M, Galluzzo M, Ianniello S, Brunese L. Diagnostic imaging of blunt abdominal trauma in pediatric patients. Radiol Med. 2016 May;121(5):409-30. doi: 10.1007/s11547-016-0637-2. Epub 2016 Apr 13.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Contrast-Enhanced Ultrasound using Lumason in people with Abdominal Injuries and Physical Abuse, run by Children's Hospital of Philadelphia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03473249, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.