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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

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 Computed Tomography (CT) in the detection of abdominal solid organ injury in young children \< 8 years of age with concern for blunt abdominal trauma.

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 data supports the effectiveness of the treatment Lumason for wounds and injuries?

Lumason, which contains sulfur hexafluoride microbubbles, is effective in enhancing ultrasound images for diagnosing liver lesions, as shown by its FDA approval and widespread use in Europe and Asia. This suggests it may also be useful in improving ultrasound imaging for other conditions, like wounds and injuries. ^{1 2 3 4 5}

Is Lumason (sulfur hexafluoride lipid-type A microspheres) safe for use in humans?

Lumason is generally considered safe for use in humans, including those with heart and lung conditions, based on studies and over 20 years of market use. However, rare serious allergic reactions and a few life-threatening cases have been reported, so medical staff should be prepared to handle such events. ^{3 5 6 7 8}

How does contrast-enhanced ultrasound differ from other treatments for wounds and injuries?

Contrast-enhanced ultrasound (CEUS) is unique because it uses microbubbles filled with gases like sulfur hexafluoride to enhance ultrasound images, allowing for better visualization of blood flow and tissue structure. This approach is different from traditional imaging methods as it provides real-time, detailed images without the need for radiation or invasive procedures, making it particularly useful for assessing and treating wounds and injuries. ^{1 3 4 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 (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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prolonging the ultrasound signal enhancement from thrombi using targeted microbubbles based on sulfur-hexafluoride-filled gas. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Microbubble Composition and Preparation for High-Frequency Contrast-Enhanced Ultrasound Imaging: In Vitro and In Vivo Evaluation. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Safety findings after intravenous administration of sulfur hexafluoride microbubbles to 463,434 examinations at 24 centers. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Anaphylaxis to Lumason Contrast Agent in Echocardiography after Immune Sensitization: A Case Report and Literature Review. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Safety of Lumason® (SonoVue®) in special populations and critically ill patients. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

A Case Report of Cardiac Arrest After Intravenous Administration of Sulfur Hexafluoride (Lumason&#174;) Ultrasound Enhancing Agent. [2023]

9. China pubmed.ncbi.nlm.nih.gov

[Preliminary Application of Contrast-Enhanced Ultrasound in the Treatment of Diabetic Ulcers]. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Highly Uniform Perfluoropropane-Loaded Cerasomal Microbubbles As a Novel Ultrasound Contrast Agent. [2018]