The Role of Contrast Enhanced Ultrasound in Appendicitis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-04

Study Completion Date

2022-07-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis

NCT03295656

Appendicitis Acute

WITHDRAWN PHASE1

CEUS for Blunt Abdominal Trauma in Children

NCT03490929

Trauma Abdomen

RECRUITING PHASE4

Point of Care 3D Ultrasound for Pediatric Appendicitis: a Pilot Study

NCT02507674

Appendicitis

COMPLETED

Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy

NCT02786810

Urinary Tract Infection Vesicoureteral Reflux

COMPLETED PHASE2

Pediatric Appendicitis Risk Calculator (pARC) in Children With Appendix Ultrasounds

NCT03522233

Appendicitis

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Appendicitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

IV sulfur hexafluoride lipid-type A microspheres, 0.03 mL/kg, up to 2 doses per examination, total dose not to exceed 4.8 mL. Single examination per patient.

Group Type EXPERIMENTAL

Sulfur hexafluoride lipid-type A microspheres

Intervention Type DRUG

Contrast Enhanced Ultrasound of the appendix

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sulfur hexafluoride lipid-type A microspheres

Contrast Enhanced Ultrasound of the appendix

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lumason

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Present to Children's Mercy Adele Hall campus with a clinical concern for acute appendicitis
* Age 8 through 17 years
* seen between Institutional Review Board (IRB) approval date and 12/31/2019
* Seen Monday- Friday between the hours of 9:00 a.m. and 4:00 pm
* Has had an IV catheter placed as part of their standard of care

Exclusion Criteria

* Known cardiac abnormality
* Pulmonary hypertension
* Known sensitivity to sulfur hexafluoride, polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), or palmitic acid
* Does not had an IV catheter placed
* Unable to roll over
* Unable to assent
* Pregnant
* Lactating
* Received an ultrasound image from a referring facility

Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No