Trial Outcomes & Findings for CEUS Evaluation of Hypoxic Ischemic Injury (NCT NCT03549520)
NCT ID: NCT03549520
Last Updated: 2025-05-14
Results Overview
Comparison of brain perfusion between normal subjects (those with suspected or at risk of HII but turn out to be normal on imaging and clinical evaluation) versus HII patients
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1 participants
Primary outcome timeframe
During contrast-enhanced ultrasound examination, up to 15 minutes.
Results posted on
2025-05-14
Participant Flow
Main reasons for lack of enrollment were the presence of clinical instability and/or pulmonary insufficiency/hypertension.
Participant milestones
| Measure |
Brain Contrast-enhanced Ultrasonography
Intravenous administration of contrast agent Sulfur hexafluoride lipid-type A microspheres before performing contrast-enhanced ultrasound (CEUS). In pediatric patients, after reconstitution 0.03 mL per kg is administered intravenously. The weight-based dose of 0.03 mL per kg will be repeated one time during a single examination. Following each injection, an intravenous flush of 0.9% Sodium Chloride is injected. The study duration per subject will be approximately 15 minutes including the time to prepare the contrast agent and perform the CEUS, as well as the 60 minute monitoring period after the first and second injection of the contrast agent.
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CEUS Evaluation of Hypoxic Ischemic Injury
Baseline characteristics by cohort
| Measure |
Brain Contrast-enhanced Ultrasonography
n=1 Participants
Intravenous administration of contrast agent Sulfur hexafluoride lipid-type A microspheres before performing contrast-enhanced ultrasound (CEUS). In pediatric patients, after reconstitution 0.03 mL per kg is administered intravenously. The weight-based dose of 0.03 mL per kg will be repeated one time during a single examination. Following each injection, an intravenous flush of 0.9% Sodium Chloride is injected. The study duration per subject will be approximately 15 minutes including the time to prepare the contrast agent and perform the CEUS, as well as the 60 minute monitoring period after the first and second injection of the contrast agent.
Sulfur hexafluoride lipid-type A microspheres: Injection of Sulfur hexafluoride lipid-type A microspheres (Lumason) contrast agent will be performed via the existing peripheral intravenous line using the FDA-recommended dose of 0.03 mg/kg.
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
14 Days
STANDARD_DEVIATION 0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: During contrast-enhanced ultrasound examination, up to 15 minutes.Population: One subject was enrolled, therefore, no comparison was possible. The patient presented with HII confirmed by MRI.
Comparison of brain perfusion between normal subjects (those with suspected or at risk of HII but turn out to be normal on imaging and clinical evaluation) versus HII patients
Outcome measures
| Measure |
Brain Contrast-enhanced Ultrasonography
n=1 Participants
Intravenous administration of contrast agent Sulfur hexafluoride lipid-type A microspheres before performing CEUS through an existing peripheral intravenous line using the FDA-recommended dose of 0.03 mg/kg. Two bolus injections will be performed and several 2-minute cine clips as well as static images will be acquired during the exam.
|
|---|---|
|
Detection of Brain Perfusion Abnormalities Using Contrast-enhanced Ultrasound
Patients with HII who underwent CEUS examination
|
1 Participants
|
|
Detection of Brain Perfusion Abnormalities Using Contrast-enhanced Ultrasound
Patients without HII who underwent CEUS examination
|
0 Participants
|
SECONDARY outcome
Timeframe: During contrast-enhanced ultrasound examination, up to 15 minutes.Population: Evaluation of brain CEUS diagnostic quality
Scoring system of non-diagnostic (1), moderate artifacts degrading diagnostic quality (2), mild artifacts without degradation of diagnostic quality (3), and diagnostic (4).
Outcome measures
| Measure |
Brain Contrast-enhanced Ultrasonography
n=1 Participants
Intravenous administration of contrast agent Sulfur hexafluoride lipid-type A microspheres before performing CEUS through an existing peripheral intravenous line using the FDA-recommended dose of 0.03 mg/kg. Two bolus injections will be performed and several 2-minute cine clips as well as static images will be acquired during the exam.
|
|---|---|
|
Number of Participants With Completed Brain CEUS Exams, Categorized by Diagnostic-Quality Scoring System
Non-diagnostic
|
0 Participants
|
|
Number of Participants With Completed Brain CEUS Exams, Categorized by Diagnostic-Quality Scoring System
Mild artifacts without degradation of diagnostic quality
|
0 Participants
|
|
Number of Participants With Completed Brain CEUS Exams, Categorized by Diagnostic-Quality Scoring System
Moderate artifacts degrading diagnostic quality
|
0 Participants
|
|
Number of Participants With Completed Brain CEUS Exams, Categorized by Diagnostic-Quality Scoring System
Diagnostic
|
1 Participants
|
Adverse Events
Brain Contrast-enhanced Ultrasonography
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place