Contrast-Enhanced Ultrasound for Abdominal Injuries

Recruiting in Palo Alto (17 mi)

Overseen by Aaron E Chen, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Allergy to Lumason, Heart disease, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

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

What data supports the effectiveness of the treatment Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON] for abdominal injuries?

Research shows that Lumason, which contains sulfur hexafluoride microbubbles, is effective in characterizing liver lesions, suggesting it may also be useful in identifying abdominal injuries. This treatment is widely used in Europe and Asia, and studies indicate it has high sensitivity and specificity, meaning it is good at correctly identifying conditions. ^{1 2 3 4 5}

How does the treatment Contrast-Enhanced Ultrasound for Abdominal Injuries differ from other treatments?

Contrast-Enhanced Ultrasound (CEUS) uses sulfur hexafluoride microbubbles to enhance ultrasound images, making it unique compared to other imaging techniques like CT or MRI, which do not use microbubbles. This method is non-invasive and provides real-time imaging, which can be particularly useful for assessing abdominal injuries. ^{1 2 3 5 6}

Eligibility Criteria

This trial is for children who may have internal injuries from blunt force to the belly. They must be stable enough not to need immediate surgery or a massive blood transfusion, and they should already be scheduled for or have had a CT scan. Kids with allergies to Lumason ingredients, heart disease, or penetrating abdominal wounds can't join.

Inclusion Criteria

I have had or might have had a blunt injury to my abdomen.

I have had or will have a CT scan of my abdomen.

I am not in need of an emergency blood transfusion or surgery within the next hour.

Exclusion Criteria

I am allergic to Lumason or its components.

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

Co-existing penetrating abdominal trauma

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Evaluation

Participants undergo contrast-enhanced ultrasound (CEUS) and conventional CT scan for evaluation of intra-abdominal organ injury

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness of imaging techniques after initial evaluation

4 weeks

Treatment Details

Interventions

• Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON] (Contrast Agent)

Trial Overview The study is testing if contrast-enhanced ultrasound using LUMASON can spot internal organ damage in kids with belly injuries as an alternative to CT scans. This could avoid radiation exposure and be done right at the bedside without moving the child.

Participant Groups

Group I: Contrast-enhanced ultrasound arm Experimental Treatment 2 Interventions

contrast-enhanced ultrasound

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Children's Hospital of Philadelphia Philadelphia, PA

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia Lead Sponsor

References

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

Contrast enhanced ultrasound for focal liver lesions: how accurate is it? [2019] With the recent FDA approval for characterization of focal liver lesions (FLL) in both pediatric and adult patients using Lumason (sulfur hexafluoride microbubbles), increased use of ultrasound contrast for routine clinical use is expected. This agent has been available for many years in Europe and Asia, and a large body of literature is available regarding the sensitivity and specificity of this agent. In addition, a few studies have directly compared CEUS to CECT and CEMRI for the characterization of focal liver lesions. This paper reviews the literature to provide a background to investigators in the United States as to the accuracy of CEUS in the characterization of FLL. This paper reviews the literature regarding sulfur hexafluoride microbubbles (Lumason in the USA and Sonovue in the rest of the world) since it is the only FDA approved agent in the USA for characterization of FLL. The results of other ultrasound contrast agents which are not FDA approved for abdominal indications (approval for cardiac indications) most likely will have similar results.

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

Prolonging the ultrasound signal enhancement from thrombi using targeted microbubbles based on sulfur-hexafluoride-filled gas. [2016] The objective of this study is to develop and characterize new microbubbles based on lipids and sulfur hexafluoride (SF6) for targeting thrombi as an improved ultrasound contrast agent.

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

How to Develop a Contrast-Enhanced Ultrasound Program. [2018] With the recent Food and Drug Administration approval of Lumason (sulfur hexafluoride lipid-type A microsphere, Bracco Diagnostics Inc, Monroe Township, NJ) for contrast-enhanced ultrasound (CEUS) to characterize focal liver lesions in both adult and pediatric patients, widespread use of CEUS is expected in the United States. This paper provides guidance in setting up a CEUS program, and reviews the practical details that will need to be instituted in a standard ultrasound department to provide both safe and efficient use of CEUS. A review of the indications, contraindications, adverse events, instructions for performing the exam, and image interpretation are discussed.

4. England pubmed.ncbi.nlm.nih.gov

Effect of SonoVue on the synovial membrane in rabbit knees. [2019] The purpose of this study was to evaluate the effect of intra-articular injection of SonoVue (sulfur hexafluoride with a phospholipid shell; Bracco SpA, Milan, Italy) on the synovial membrane in an animal model.

5. England pubmed.ncbi.nlm.nih.gov

Safety of intravenous application of second-generation ultrasound contrast agent in children: prospective analysis. [2022] The goal of the work described here was to assess the safety profile of intravenous second-generation ultrasound contrast agents (UCAs) containing sulfur hexafluoride in pediatric contrast-enhanced ultrasound. Between 2010 and 2013, a total of 167 examinations were performed in 137 children referred by the Oncology Department. Approval by an Independent Ethical Review Board on Scientific Research for the intravenous use of an UCA containing sulfur hexafluoride in children with oncologic diseases was obtained. Consent for UCA administration was acquired from the parents or legal guardians. Severe anaphylactic reaction was observed in 0.6% (n = 1). No other adverse events during or after intravenous administration of contrast were observed in the examined group (no changes in heart rate and rhythm, blood pressure, oxygen saturation or respiratory rate). There were no reports of subjective flushing, nausea, transient headaches or altered taste. Although second-generation ultrasound contrast agents are considered potentially safe, all investigators should be prepared for the development of adverse reactions and have provisions in place for all pediatric intravenous contrast-enhanced ultrasound examinations. More multicenter studies are essential to determination of an accurate UCA safety profile.

6. Germany pubmed.ncbi.nlm.nih.gov

Safety findings after intravenous administration of sulfur hexafluoride microbubbles to 463,434 examinations at 24 centers. [2023] We aimed to evaluate the safety of the ultrasound contrast agent sulfur hexafluoride microbubbles in a large group of patients referred for routine contrast-enhanced ultrasound (CEUS).