Acute AppendicitisPhase 2NCT03687502
The Role of Contrast Enhanced Ultrasound in Appendicitis
A Phase 2 study testing Sulfur hexafluoride lipid-type A microspheres in people with Acute Appendicitis, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- Sulfur hexafluoride lipid-type A microspheres
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2019to 5 Jul 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnant
- Lactating
- Received an ultrasound image from a referring facility
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Kansas City
Kansas City, Missouri, 64108
About this study
Official title: The Role of Contrast Enhanced Ultrasound in The Diagnosis of Children With Appendicitis
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.
Read the 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.
- Conditions
- Acute Appendicitis
- Being tested
- Sulfur hexafluoride lipid-type A microspheres
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfur hexafluoride lipid-type A microspheresDrug
Also called Lumason
Contrast Enhanced Ultrasound of the appendix
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sulfur hexafluoride lipid-type A microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Secondary outcomes (5)
Definitive Diagnosis
Proportion of children with definitive diagnosis of appendicitis with use of CEUS.
Measured: 1 week
Number of Participants Who Required Additional CT Scan
"Number of Participants who Required Additional CT Scan"
Measured: 30 days
Percentage of Negative Appendectomies
Percentage of negative appendectomies
Measured: 1 week
Total Cost Difference Compared to Traditional Ultrasound
Costs in comparison to traditional ultrasound
Measured: 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.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start4 Jan 2019
- Primary completion26 Mar 2021
- Study completion5 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tolulope Oyetunji, Children's Mercy Hospital Kansas City
- Investigators
- Tolulope Oyetunji, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687502
- Sponsor's protocol ID
- Study00000329
- Status last verified
- Sep 2023
- First submitted
- 24 Sep 2018
- Last updated
- 8 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Contrast Enhanced Ultrasound in The Diagnosis of Children With Appendicitis
- ClinicalTrials.gov ID
- NCT03687502
- Acronym / sponsor ID
- Study00000329
- Conditions
- Acute Appendicitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 27 Sep 2018 (actual)
- Results
- Posted 1 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Sulfur hexafluoride lipid-type A microspheresIV 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. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulfur hexafluoride lipid-type A microspheresAlso: LumasonContrast Enhanced Ultrasound of the appendix | Drug | Experimental |
Primary outcome
Number of Children With an Accurate Diagnosis of Appendicitis.
Time frame: 1 week
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
5 secondary outcomes
Definitive Diagnosis
Time frame: 1 week
Number of Participants Who Required Additional CT Scan
Time frame: 30 days
Percentage of Negative Appendectomies
Time frame: 1 week
Total Cost Difference Compared to Traditional Ultrasound
Time frame: 60 days
Total Cost Difference Between Traditional Ultrasound in Comparison to Costs in CT Scan.
Time frame: 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Acute Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
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PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
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Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tolulope Oyetunji, MD principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sulfur hexafluoride lipid-type A microspheres in people with Acute Appendicitis, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Children With an Accurate Diagnosis of Appendicitis. (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.