The Role of Contrast Enhanced Ultrasound in Appendicitis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Appendicitis

Intervention / Treatment
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* Drug: Sulfur hexafluoride lipid-type A microspheres


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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. | Drug: Sulfur hexafluoride lipid-type A microspheres<br>* Contrast Enhanced Ultrasound of the appendix<br>* Other names: Lumason;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Children With an Accurate Diagnosis of Appendicitis. | Number of children with an accurate diagnosis of appendicitis when compared to the standard grey scale ultrasound and/ or CT scan based on the following categories: Category 1: Normal appendix Category 2: Appendix not fully visualized without secondary signs Category 3: Appendix not fully visualized with secondary signs Category 4: Appendicitis | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Definitive Diagnosis | Proportion of children with definitive diagnosis of appendicitis with use of CEUS. | 1 week | 
| Number of Participants Who Required Additional CT Scan | Number of Participants who Required Additional CT Scan | 30 days | 
| Percentage of Negative Appendectomies | Percentage of negative appendectomies | 1 week | 
| Total Cost Difference Compared to Traditional Ultrasound | Costs in comparison to traditional ultrasound | 60 days | 
| Total Cost Difference Between Traditional Ultrasound in Comparison to Costs in CT Scan. | Comparing total costs difference between traditional ultrasound in comparison to costs in CT scan. Total CT Scan Costs - Total Ultrasound Costs = Cost Difference. | 60 days |