The Role of Contrast Enhanced Ultrasound in Appendicitis

Children's Mercy Hospital Kansas City

Status and phase: Completed; Phase 2

Conditions: Acute Appendicitis

Treatments: Drug: Sulfur hexafluoride lipid-type A microspheres

Study type: Interventional

Funder types: Other

Identifiers

NCT03687502

Study00000329

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Experimental

Experimental group

Description:

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.

Treatment:

Drug: Sulfur hexafluoride lipid-type A microspheres