Contrast-Enhanced Ultrasound for Wounds and Injuries

Overseen By Kate Henry, MD, MSCE

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Allergy to Lumason, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special type of ultrasound, called contrast-enhanced ultrasound (CEUS), to evaluate its effectiveness in identifying abdominal organ injuries. It compares CEUS results with those from CT scans, which are commonly used for detecting such injuries. The trial employs a contrast agent called Lumason (sulfur hexafluoride lipid-type A microspheres) to enhance ultrasound image clarity. It seeks children under 8 who have sustained an abdominal injury and are stable enough not to require immediate surgery. Children who have had a CT scan ordered or performed for their injury may be suitable candidates for this trial. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for Lumason?

Research shows that Lumason, the treatment used in the contrast-enhanced ultrasound for this trial, is generally safe for people, including children. One review found that while some children experienced minor side effects, these were uncommon. Specifically, out of 54 children, 76 minor side effects were reported, with 31 children experiencing 47 events after using Lumason.

Additionally, another study found that Lumason had a very low death rate of just 0.03% in patients who received it, lower than in those who did not receive any ultrasound contrast agent. This suggests that Lumason is well-tolerated. Overall, these findings provide strong evidence of Lumason's safety in children, making it a promising option for use in imaging tests. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using contrast-enhanced ultrasound (CEUS) with Lumason for diagnosing wounds and injuries because it offers a safer, less invasive alternative to traditional CT scans, especially important for children. Unlike CT scans, which involve radiation exposure, CEUS uses sound waves and an injectable contrast agent, Lumason, to provide detailed images of the body's internal structures. This method could significantly reduce the risks associated with radiation, making it a preferable choice for pediatric patients. Additionally, CEUS can be performed at the bedside, offering quicker results and potentially speeding up the diagnosis and treatment process.

What evidence suggests that contrast-enhanced ultrasound is effective for detecting abdominal trauma in young children?

Research has shown that Lumason, used in contrast-enhanced ultrasound (CEUS), may help detect abdominal injuries in children. In this trial, one group will undergo CEUS with Lumason to evaluate its effectiveness compared to traditional CT scans in identifying organ injuries from blunt abdominal trauma. CEUS offers a safer option, particularly for young children, as it avoids the radiation associated with CT scans. Lumason is already trusted for use in pediatric heart ultrasounds, supporting its safety and reliability. Overall, CEUS with Lumason presents a promising method to diagnose injuries without radiation risks. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for children under 8 years old who have experienced blunt abdominal trauma, such as from physical abuse or accidents. They must be clinically stable with an IV in place and scheduled for or have already had an abdominal CT scan. Children with known heart disease, allergies to Lumason ingredients, or unable to get the ultrasound within 72 hours after CT are excluded.

Inclusion Criteria

IV in place

I do not need emergency surgery within the next hour.

I have had or will have an abdominal CT scan.

Exclusion Criteria

Unable to obtain contrast-enhanced ultrasound within 72 hours after CT

I have a known heart condition from birth or acquired later.

I am allergic to Lumason or its ingredients.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prospective Observation

Prospective observation of comparison of CT and CEUS results among children who are undergoing a CEUS and abdominal CT as part of clinical care.

2 years

Retrospective Review

Comparison of CT and CEUS results from retrospective chart review of children who have had a CEUS for trauma.

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lumason

Trial Overview The study tests how well contrast-enhanced ultrasound (CEUS) using Lumason detects internal injuries compared to a standard abdominal CT scan in young children following blunt trauma. It aims to determine the accuracy of CEUS by measuring its sensitivity and specificity.

How Is the Trial Designed?

Group I: Contrast-Enhanced Ultrasound using Lumason Experimental Treatment 1 Intervention

Prospective intervention using contrast enhanced ultrasound with IV contrast Lumason.

Group II: Prospective Observation Active Control 1 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.

Group III: Retrospective Review Active Control 1 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).

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

The Ray E. Helfer Society

Collaborator

Trials

1

Recruited

120+

Published Research Related to This Trial

The FDA has approved Lumason, a contrast agent for ultrasound, which is expected to enhance the characterization of focal liver lesions in both adults and children, promoting the use of contrast-enhanced ultrasound (CEUS) in clinical practice.

The paper outlines essential guidelines for establishing a CEUS program, including safety measures, indications, contraindications, and procedures for performing and interpreting CEUS exams, ensuring efficient and safe implementation in ultrasound departments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to Develop a Contrast-Enhanced Ultrasound Program. Barr, RG.[2018]

Lumason (sulfur hexafluoride microbubbles) has recently been FDA approved for characterizing focal liver lesions (FLL) in both pediatric and adult patients, which is expected to increase its use in routine clinical practice.

The literature indicates that contrast-enhanced ultrasound (CEUS) using Lumason is accurate for FLL characterization, with existing studies comparing its effectiveness to contrast-enhanced computed tomography (CECT) and contrast-enhanced magnetic resonance imaging (CEMRI).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast enhanced ultrasound for focal liver lesions: how accurate is it? Barr, RG.[2019]

The study developed new microbubbles using lipids and sulfur hexafluoride (SF6) that significantly enhance the echogenicity of thrombi, improving their visibility during ultrasound imaging.

These targeted microbubbles demonstrated high stability and maintained their characteristics for up to 8 hours, providing a longer diagnostic window compared to traditional nontargeted microbubbles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonging the ultrasound signal enhancement from thrombi using targeted microbubbles based on sulfur-hexafluoride-filled gas. Wang, B., Zang, WJ., Wang, M., et al.[2016]

Lumason® (SonoVue®) has been shown to be safe for use in special patient populations, including those with compromised cardiopulmonary conditions, with no significant adverse effects on cardiac or pulmonary function observed in studies involving patients with coronary artery disease, pulmonary hypertension, and chronic obstructive pulmonary disease.

A retrospective study of critically ill patients indicated that using Lumason® during echocardiography did not increase in-hospital mortality compared to echocardiography without the contrast agent, further supporting its safety profile in vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Lumason® (SonoVue®) in special populations and critically ill patients. Filippone, A., Kirchin, MA., Monteith, J., et al.[2023]

In a large study of 463,434 contrast-enhanced ultrasound examinations, the use of sulfur hexafluoride microbubbles resulted in a very low adverse event (AE) frequency of only 0.034%, indicating a high safety profile for this contrast agent.

Among the reported AEs, only 4 were classified as serious, and the majority were non-serious, with most reactions occurring within 30 minutes of administration, confirming that sulfur hexafluoride microbubbles are safe for routine clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety findings after intravenous administration of sulfur hexafluoride microbubbles to 463,434 examinations at 24 centers. Shang, Y., Xie, X., Luo, Y., et al.[2023]

Citations

1. fda.gov fda.gov/media/133813/download

CLINICAL REVIEW Lumason will be the first ultrasound contrast agent approved for echocardiography in the pediatric population. Risk-Benefit Assessment. The ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03473249

Effectiveness of Contrast-Enhanced Ultrasound The primary objective in this study is to determine the sensitivity and specificity of contrast-enhanced ultrasound (CEUS) compared to abdominal Computed ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11805793/

Diagnostic performance of contrast-enhanced ultrasound ... This study highlights the diagnostic potential of CEUS for pediatric solid organ injuries caused by BAT.

4. bracco.com bracco.com/en-us/media/3810

New Nationwide Real-World Data Validates the Safety of ... injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres. Most serious reactions occur within 30 minutes of ...

5. lumason.com lumason.com/

LUMASON Home Page - LUMASON LUMASON (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous use or intravesical use is an ultrasound contrast agent.

6. lumason.com lumason.com/safety/

Safety Patients who received LUMASON UEA had a mortality rate of only 0.03%—lower than in those who didn't receive a UEA.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11459369/

Contrast-enhanced ultrasound: a comprehensive review ... A total of 54 children reportedly had 76 non-serious adverse events following intravenous CEUS: 31 children with 47 events following SonoVue/Lumason.

8. withpower.com withpower.com/trial/phase-4-wounds-and-injuries-4-2018-4df8d

Contrast-Enhanced Ultrasound for Wounds and Injuries Is Lumason (sulfur hexafluoride lipid-type A microspheres) safe for use in humans? Lumason is generally considered safe for use in humans, including those ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02552238

Evaluation of Safety and Efficacy of Lumason/SonoVue in ... The study was designed to assess the safety and efficacy of Lumason at improving the visualization of the LV EBD during pharmacologic stress echocardiography ...