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

Study00000329

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.

2019-01-04

2021-03-26

2022-07-05

Completed

Early phase I

37

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': "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."}}, 'enrollmentInfo': {'count': 37, 'type': 'ACTUAL'}}

2023-09-08