The Role of Contrast Enhanced Ultrasound in Appendicitis

NCT03687502 | Completed Phase 2 Results FDA Drug

• 1 other identifier: Study00000329
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Appendicitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Definitive Diagnosis

  1 week

• Number of Participants Who Required Additional CT Scan

  30 days

• Percentage of Negative Appendectomies

  1 week

• Total Cost Difference Compared to Traditional Ultrasound

  60 days

• Total Cost Difference Between Traditional Ultrasound in Comparison to Costs in CT Scan.

  60 days

Study Arms (1)

Experimental

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.

Drug: Sulfur hexafluoride lipid-type A microspheres

Interventions

Sulfur hexafluoride lipid-type A microspheres DRUG

Contrast Enhanced Ultrasound of the appendix

Also known as: Lumason

Experimental

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Results Point of Contact

• Title: Dr. Tolulope Oyetunji
• Organization: Children's Mercy Hospital

taoyetunji@cmh.edu

816-234-3575

Study Officials

• Tolulope Oyetunji, MD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Director, Health Outcomes Research, Department of Surgery

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: September 27, 2018
• Study Start: January 4, 2019
• Primary Completion: March 26, 2021
• Study Completion: July 5, 2022
• Last Updated: September 8, 2023
• Results First Posted: December 1, 2022

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)