Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulfur hexafluoride lipid-type A microspheres | Drug | Contrast Enhanced Ultrasound of the appendix |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Definitive Diagnosis | Proportion of children with definitive diagnosis of appendicitis with use of CEUS. | 1 week |
| Number of Participants Who Required Additional CT Scan | "Number of Participants who Required Additional CT Scan" |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tolulope Oyetunji, MD | Children's Mercy Hospital Kansas City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Kansas City | Kansas City | Missouri | 64108 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. Sulfur hexafluoride lipid-type A microspheres: Contrast Enhanced Ultrasound of the appendix |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects who completed both the greyscale and contrast enhanced ultrasound.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Contrast Enhanced Ultrasound Group | 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. Sulfur hexafluoride lipid-type A microspheres: Contrast Enhanced Ultrasound of the appendix |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 1 week |
|
60 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Sulfur hexafluoride lipid-type A microspheres: Contrast Enhanced Ultrasound of the appendix |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tolulope Oyetunji | Children's Mercy Hospital | 816-234-3575 | taoyetunji@cmh.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 20, 2020 | Feb 23, 2022 | Prot_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| 30 days |
| Percentage of Negative Appendectomies | Percentage of negative appendectomies | 1 week |
| Total Cost Difference Compared to Traditional Ultrasound | Costs in comparison to traditional ultrasound | 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. | 60 days |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Definitive Diagnosis | Proportion of children with definitive diagnosis of appendicitis with use of CEUS. | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | Number of Participants Who Required Additional CT Scan | "Number of Participants who Required Additional CT Scan" | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Percentage of Negative Appendectomies | Percentage of negative appendectomies | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | Total Cost Difference Compared to Traditional Ultrasound | Costs in comparison to traditional ultrasound | Posted | Number | Dollars | 60 days |
|
|
|
| Secondary | 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. | Posted | Number | Dollars | 60 days |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
Not provided
Not provided
Not provided
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |