NCT03687502

The Role of Contrast Enhanced Ultrasound in Appendicitis

The Role of Contrast Enhanced Ultrasound in The Diagnosis of Children With Appendicitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Children's Mercy Hospital Kansas City · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to determine the efficacy of Contrast Enhanced Ultrasound (CEUS) in improving the diagnosis of acute appendicitis in children, when compared to the standard grey-scale ultrasound.

Detailed description

This will be a single-center, non-randomized trial that will add to our institution's current diagnostic algorithm using Contrast Enhanced Ultra Sound (CEUS) in subjects who are clinically suspicious for acute appendicitis. For those who consent to study participation, we propose obtaining a CEUS after the initial gray-scale ultrasound. Once the initial ultrasound is complete, the contrast Lumason® (sulfur hexafluoride lipid type-A microspheres) will be administered through an already existing IV catheter and an abdominal scan will be completed. The patient will then continue with standard of care treatment per his treating physician. The CEUS image will be read at a future time by a Children's Mercy Hospital radiologist blinded to the results of the gray scale ultrasound and computed tomography (CT) scan if one was obtained; these will be used for comparison.

Conditions

• Acute Appendicitis

Interventions

Type	Name	Description
DRUG	Sulfur hexafluoride lipid-type A microspheres	Contrast Enhanced Ultrasound of the appendix

Timeline

• Start date: 2019-01-04
• Primary completion: 2021-03-26
• Completion: 2022-07-05
• First posted: 2018-09-27
• Last updated: 2023-09-08
• Results posted: 2022-12-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study