A Phase 2 interventional study of Sulfur hexafluoride lipid-type A microspheres in Acute Appendicitis, sponsored by Children's Mercy Hospital Kansas City. Completed at 1 site in United States. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-09-08.
Sponsored by Children's Mercy Hospital Kansas City · Phase 2, Interventional, and Diagnostic
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.
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.
412 studies on the registry are indexed under Appendicitis; 62 are open to participants now.
This study's enrollment of 37 is below the median of 111 across 246 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →Children's Mercy Hospital Kansas City is the lead sponsor of 209 studies on the registry; 22 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Contrast Enhanced Ultrasound of the appendix
Also known as: Lumason
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
Time frame: 1 week
Definitive Diagnosis
Proportion of children with definitive diagnosis of appendicitis with use of CEUS.
Time frame: 1 week
Number of Participants Who Required Additional CT Scan
"Number of Participants who Required Additional CT Scan"
Time frame: 30 days
Percentage of Negative Appendectomies
Percentage of negative appendectomies
Time frame: 1 week
Total Cost Difference Compared to Traditional Ultrasound
Costs in comparison to traditional ultrasound
Time frame: 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.
Time frame: 60 days
| Milestone | Experimental |
|---|---|
| Started | 37 |
| Completed | 35 |
| Not completed | 2 |
| Withdrew: Iv was removed prior to radiology visit for ultrasound | 1 |
| Withdrew: Lumason not available | 1 |
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
| Participants | Contrast Enhanced Ultrasound Group |
|---|---|
| Category 1 | 6 |
| Category 2 | 15 |
| Category 3 | 1 |
| Category 4 | 13 |
Proportion of children with definitive diagnosis of appendicitis with use of CEUS.
| Participants | Contrast Enhanced Ultrasound Group |
|---|---|
| Definitive Diagnosis | 13 |
"Number of Participants who Required Additional CT Scan"
| Participants | Experimental |
|---|---|
| Number of Participants Who Required Additional CT Scan | 0 |
Percentage of negative appendectomies
| Participants | Contrast Enhanced Ultrasound Group |
|---|---|
| Percentage of Negative Appendectomies | 1 |
Costs in comparison to traditional ultrasound
| Dollars | Contrast Enhanced Ultrasound Group |
|---|---|
| Total Cost Difference Compared to Traditional Ultrasound | 16 |
Comparing total costs difference between traditional ultrasound in comparison to costs in CT scan. Total CT Scan Costs - Total Ultrasound Costs = Cost Difference.
| Dollars | Contrast Enhanced Ultrasound Group |
|---|---|
| Total Cost Difference Between Traditional Ultrasound in Comparison to Costs in CT Scan. | 6198 |
Collected over 60 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
Subjects who completed both the greyscale and contrast enhanced ultrasound.
| Age, Categorical(Participants) | Contrast Enhanced Ultrasound Group |
|---|---|
| <=18 years | 35 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Contrast Enhanced Ultrasound Group |
|---|---|
| Median | 11.4 (10 to 14.8) |
| Sex: Female, Male(Participants) | Contrast Enhanced Ultrasound Group |
|---|---|
| Female | 20 |
| Male | 15 |
| Race/Ethnicity, Customized(Participants) | Contrast Enhanced Ultrasound Group |
|---|---|
| White | 26 |
| Black | 2 |
| Hispanic | 3 |
| Multiracial | 3 |
| Other | 1 |
| Region of Enrollment(participants) | Contrast Enhanced Ultrasound Group |
|---|---|
| United States | 35 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Children's Mercy Hospital Kansas City