Trial Outcomes & Findings for The Role of Contrast Enhanced Ultrasound in Appendicitis (NCT NCT03687502)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

37 participants

Primary outcome timeframe

1 week

Results posted on

2023-09-08

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	37
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study IV was removed prior to radiology visit for ultrasound	1
Overall Study Lumason not available	1

Baseline Characteristics

The Role of Contrast Enhanced Ultrasound in Appendicitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Contrast Enhanced Ultrasound Group n=35 Participants 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
Age, Categorical <=18 years	35 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	11.4 years n=93 Participants
Sex: Female, Male Female	20 Participants n=93 Participants
Sex: Female, Male Male	15 Participants n=93 Participants
Race/Ethnicity, Customized White	26 Participants n=93 Participants
Race/Ethnicity, Customized Black	2 Participants n=93 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=93 Participants
Race/Ethnicity, Customized Multiracial	3 Participants n=93 Participants
Race/Ethnicity, Customized Other	1 Participants n=93 Participants
Region of Enrollment United States	35 participants n=93 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Contrast Enhanced Ultrasound Group n=35 Participants 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.
Number of Children With an Accurate Diagnosis of Appendicitis. Category 1	6 Participants
Number of Children With an Accurate Diagnosis of Appendicitis. Category 2	15 Participants
Number of Children With an Accurate Diagnosis of Appendicitis. Category 3	1 Participants
Number of Children With an Accurate Diagnosis of Appendicitis. Category 4	13 Participants

SECONDARY outcome

Timeframe: 1 week

Proportion of children with definitive diagnosis of appendicitis with use of CEUS.

Outcome measures

Outcome measures
Measure	Contrast Enhanced Ultrasound Group n=35 Participants 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.
Definitive Diagnosis	13 Participants

SECONDARY outcome

Timeframe: 30 days

"Number of Participants who Required Additional CT Scan"

Outcome measures

Outcome measures
Measure	Contrast Enhanced Ultrasound Group n=35 Participants 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.
Number of Participants Who Required Additional CT Scan	0 Participants

SECONDARY outcome

Timeframe: 1 week

Percentage of negative appendectomies

Outcome measures

Outcome measures
Measure	Contrast Enhanced Ultrasound Group n=35 Participants 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.
Percentage of Negative Appendectomies	1 Participants

SECONDARY outcome

Timeframe: 60 days

Costs in comparison to traditional ultrasound

Outcome measures

Outcome measures
Measure	Contrast Enhanced Ultrasound Group n=35 Participants 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.
Total Cost Difference Compared to Traditional Ultrasound	16 Dollars

SECONDARY outcome

Timeframe: 60 days

Comparing total costs difference between traditional ultrasound in comparison to costs in CT scan. Total CT Scan Costs - Total Ultrasound Costs = Cost Difference.

Outcome measures

Outcome measures
Measure	Contrast Enhanced Ultrasound Group n=35 Participants 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.
Total Cost Difference Between Traditional Ultrasound in Comparison to Costs in CT Scan.	6198 Dollars

Adverse Events

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Tolulope Oyetunji

Children's Mercy Hospital

Phone: 816-234-3575

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place