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Contrast-Enhanced Ultrasound for Wounds and Injuries

Q: Has this therapy been accepted by the Food and Drug Administration?

After extensive review, our team has determined that this treatment option is approved and thus merits a safety rating of 3.

Q: Are senior citizens welcome to participate in this clinical endeavor?

This clinical trial seeks out patients who range in age from infancy up to 7 years old.

Q: Has this type of research been conducted before?

Presently, 14 trials for this drug are in progress and span 9 urban centres across 2 nations. The initial trial occurred back in 2017 when Bracco Diagnostics, Inc ran a Phase &#x3C; 1 clinical study with 125 participants. Since then, 25 more studies have concluded successfully.

Q: Have there been other examinations of this treatment's efficacy?

Currently, 14 active clinical trials are researching this treatment. Of these studies, 3 have made it to Phase 3. Philadelphia, <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a> is one of the leading locations for testing this medication with 18 different medical sites recruiting patients.

Q: How many participants is the clinical trial currently accommodating?

Recruitment for this clinical trial has ended. Initially posted on May 9th 2018 and last updated on January 3rd 2023, it is no longer enrolling patients. If you are seeking other studies, 822 trials with abdominal injuries and 14 studies regarding the specified treatment are currently recruiting participants.

Q: To whom is this clinical investigation accessible?

The criteria for this study necessitates that subjects have abdominal traumas and are between 0 to 7 years old. A total of 120 individuals must be enrolled in the trial.

Q: Is this clinical research currently accepting volunteers?

As detailed on clinicaltrials.gov, this medical research is no longer recruiting patients; the trial was first posted in May 2018 and last updated in January 2023. Fortunately, there are 836 other experiments that are actively accepting participants at the present time.

Phase 4

Waitlist Available

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinically stable (defined as not undergoing an emergent surgical procedure in the next hour)

Males or females < 8 years of age at time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is looking at using ultrasound with contrast to see if it can be used to detect abdominal injuries in children under 8 years old.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include allergic reactions related to Lumason's components like sulfa-hexafluoride lipid microsphere, polyethylene glycol, DSPC, DPPG-Na, and palmitic acid.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I do not need emergency surgery within the next hour.

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I am younger than 8 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sensitivity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age

Specificity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Contrast-Enhanced Ultrasound using LumasonExperimental Treatment1 Intervention

Prospective intervention using contrast enhanced ultrasound with IV contrast Lumason.

Group II: Prospective ObservationActive Control1 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 ReviewActive Control1 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).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor

708 Previous Clinical Trials

8,581,183 Total Patients Enrolled

1 Trials studying Abdominal Injuries

146 Patients Enrolled for Abdominal Injuries

The Ray E. Helfer SocietyUNKNOWN

Media Library

Contrast-Enhanced Ultrasound using Lumason Clinical Trial Eligibility Overview. Trial Name: NCT03473249 — Phase 4

Abdominal Injuries Research Study Groups: Prospective Observation, Contrast-Enhanced Ultrasound using Lumason, Retrospective Review

Abdominal Injuries Clinical Trial 2023: Contrast-Enhanced Ultrasound using Lumason Highlights & Side Effects. Trial Name: NCT03473249 — Phase 4

Contrast-Enhanced Ultrasound using Lumason 2023 Treatment Timeline for Medical Study. Trial Name: NCT03473249 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this therapy been accepted by the Food and Drug Administration?

"After extensive review, our team has determined that this treatment option is approved and thus merits a safety rating of 3."

Answered by AI

Are senior citizens welcome to participate in this clinical endeavor?

"This clinical trial seeks out patients who range in age from infancy up to 7 years old."

Answered by AI

Has this type of research been conducted before?

"Presently, 14 trials for this drug are in progress and span 9 urban centres across 2 nations. The initial trial occurred back in 2017 when Bracco Diagnostics, Inc ran a Phase < 1 clinical study with 125 participants. Since then, 25 more studies have concluded successfully."

Answered by AI

Have there been other examinations of this treatment's efficacy?

"Currently, 14 active clinical trials are researching this treatment. Of these studies, 3 have made it to Phase 3. Philadelphia, Pennsylvania is one of the leading locations for testing this medication with 18 different medical sites recruiting patients."

Answered by AI

How many participants is the clinical trial currently accommodating?

"Recruitment for this clinical trial has ended. Initially posted on May 9th 2018 and last updated on January 3rd 2023, it is no longer enrolling patients. If you are seeking other studies, 822 trials with abdominal injuries and 14 studies regarding the specified treatment are currently recruiting participants."

Answered by AI

To whom is this clinical investigation accessible?

"The criteria for this study necessitates that subjects have abdominal traumas and are between 0 to 7 years old. A total of 120 individuals must be enrolled in the trial."

Answered by AI

Is this clinical research currently accepting volunteers?

"As detailed on clinicaltrials.gov, this medical research is no longer recruiting patients; the trial was first posted in May 2018 and last updated in January 2023. Fortunately, there are 836 other experiments that are actively accepting participants at the present time."

Answered by AI

Recent research and studies

Journal of Pediatric SurgeryJournal

Pediatric Abdominal Injury Patterns Caused by “falls

Carter, Kyle W., and Steven L. Moulton. 2016. “Pediatric Abdominal Injury Patterns Caused by “falls”: A Comparison Between Nonaccidental and Accidental Trauma”. Journal of Pediatric Surgery. Elsevier BV. doi:10.1016/j.jpedsurg.2015.10.056.

The Journal of Trauma: Injury, Infection, and Critical CareJournal

Major Blunt Abdominal Trauma Due to Child Abuse

COOPER, ARTHUR, THOMAS FLOYD, BARBARA BARLOW, MARIA NIEMIRSKA, STEPHEN LUDWIG, TONI SEIDL, JAMES OʼNEILL, et al.. 1988. “Major Blunt Abdominal Trauma Due to Child Abuse”. The Journal of Trauma: Injury, Infection, and Critical Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00005373-198810000-00015.

PediatricsJournal

Utility of Hepatic Transaminases to Recognize Abuse in Children

Lindberg, Daniel, Kathi Makoroff, Nancy Harper, Antoinette Laskey, Kirsten Bechtel, Katherine Deye, Robert Shapiro, and for the ULTRA Investigators. 2009. “Utility of Hepatic Transaminases to Recognize Abuse in Children”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2008-2348.

American Journal of RoentgenologyJournal