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The Role of Contrast Enhanced Ultrasound in Appendicitis

Primary Purpose

Acute Appendicitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sulfur hexafluoride lipid-type A microspheres
Sponsored by
Children's Mercy Hospital Kansas City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Appendicitis

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Children's Mercy Kansas City

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Definitive Diagnosis
Proportion of children with definitive diagnosis of appendicitis with use of CEUS.
Number of Participants Who Required Additional CT Scan
"Number of Participants who Required Additional CT Scan"
Percentage of Negative Appendectomies
Percentage of negative appendectomies
Total Cost Difference Compared to Traditional Ultrasound
Costs in comparison to traditional ultrasound
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.

Full Information

First Posted
September 24, 2018
Last Updated
September 6, 2023
Sponsor
Children's Mercy Hospital Kansas City
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1. Study Identification

Unique Protocol Identification Number
NCT03687502
Brief Title
The Role of Contrast Enhanced Ultrasound in Appendicitis
Official Title
The Role of Contrast Enhanced Ultrasound in The Diagnosis of Children With Appendicitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 4, 2019 (Actual)
Primary Completion Date
March 26, 2021 (Actual)
Study Completion Date
July 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Mercy Hospital Kansas City

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Appendicitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
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.
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Sulfur hexafluoride lipid-type A microspheres
Other Intervention Name(s)
Lumason
Intervention Description
Contrast Enhanced Ultrasound of the appendix
Primary Outcome Measure Information:
Title
Number of Children With an Accurate Diagnosis of Appendicitis.
Description
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
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Definitive Diagnosis
Description
Proportion of children with definitive diagnosis of appendicitis with use of CEUS.
Time Frame
1 week
Title
Number of Participants Who Required Additional CT Scan
Description
"Number of Participants who Required Additional CT Scan"
Time Frame
30 days
Title
Percentage of Negative Appendectomies
Description
Percentage of negative appendectomies
Time Frame
1 week
Title
Total Cost Difference Compared to Traditional Ultrasound
Description
Costs in comparison to traditional ultrasound
Time Frame
60 days
Title
Total Cost Difference Between Traditional Ultrasound in Comparison to Costs in CT Scan.
Description
Comparing total costs difference between traditional ultrasound in comparison to costs in CT scan. Total CT Scan Costs - Total Ultrasound Costs = Cost Difference.
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tolulope Oyetunji, MD
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Role of Contrast Enhanced Ultrasound in Appendicitis

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