- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05694611
Preterm Neonates Brain Ultrasound With CEUS and Elastography
Contrast Enhanced Ultrasound and Elastography of the Preterm Brain
Study Overview
Status
Conditions
Detailed Description
SonoVue (sulphur hexafluoride) is a contrast agent composed of micro bubbles. It increases echogenicity of the ultrasound thus enhancing the visualisation of vessels and giving better insights into tissue perfusion. The use of sulphur hexafluoride has been approved by FDA and it has been in off-label use in Europe for years. SonoVue is thought to be especially useful for children, because it can enhance the diagnostic capabilities of ultrasound and the examination can be performed without radiation or sedation.
Elastography is a method to investigate the elasticity of a tissue by tracking the shear waves generated by the ultrasound beam. Also this method has been used in Europe and America for years.
The aim of this study is to examine cerebral hemodynamics in preterm neonates reaching term age, using ultrasound of the brain, contrast enhanced ultrasound (CEUS) and ultrasound-guided shear-wave elastography (US-SWE). The brain ultrasound, CEUS and US-SWE to preterm babies is planned to take place while having a clinically appointed brain magnetic resonance imaging at about term. Total recruitment for the study is 100 infants in total. The recruitment period will be up to seven years if needed.
The injections of SonoVue will be administered through pre-existing venous cannulas. The examination will be done in addition to the MR-imaging, after the parental consent has been given. The ultrasound examination altogether is estimated to take about 20 minutes per day. Safety monitoring period is conducted after the injection. CEUS data will be analysed with proper software. US-SWE will be measured repeatedly on both brain hemispheres and on different areas to validate the measurements. Ultrasound data will be evaluated comparing preterm neonates with and without MRI-proven brain pathology and comparing the ultrasound-achieved data to magnetic resonance imaging.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Tiina Laurikainen
- Phone Number: +35823135941
- Email: tiina.laurikainen@tyks.fi
Study Contact Backup
- Name: Riitta Parkkola
- Phone Number: +35823130148
- Email: riitta.parkkola@tyks.fi
Study Locations
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Southwestern Finland
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Turku, Southwestern Finland, Finland, 20520
- Turku University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Preterm neonates attending brain MR-imaging at term
Exclusion Criteria:
- Pre-known genetic disease
- Difficult congenital malformations that need surgical treatment
- Central nervous system tumors
- Weight less than 2,5 kg during examination
- Medical history of SonoVue hypersensitivity
- Uncontrolled systemic hypertension
- Systolic pulmonary artery pressure > 90 mmHg
- Unstable cardiovascular state
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Preterm neonates
Diagnostic Test: Brain ultrasound, brain contrast enhanced ultrasound, brain ultrasound elastography To study brain perfusion with brain ultrasound, contrast enhanced ultrasound of the brain and ultrasound-guided shear-wave elastography Drug: Sulfur Hexafluoride To evaluate brain perfusion at term in infants born prematurely Other Names: • SonoVue |
To study brain perfusion with brain ultrasound, contrast enhanced ultrasound of the brain and ultrasound-guided shear-wave elastography
To evaluate the differences in brain perfusion and elasticity studied by CEUS and shear-wave elastography, comparing term neonates with and without MRI verified brain pathologies and to compare the ultrasound CEUS and elastography data to MRI.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantitative assessment of neonatal brain perfusion using calculated time-intensity curve of enhancement in brain CEUS at term
Time Frame: 1 day
|
Quantitative analysis will be executed from a time-intensity curve generated from a region of interest and from left and right talami.
Wash-in slope and wash-out slope (measured in echo power units per second) will be measured and compared on healthy versus diseased preterm neonates at term.
|
1 day
|
Quantitative assessment of neonatal brain peak enhancement using calculated time-intensity curve of enhancement in brain CEUS at term
Time Frame: 1 day
|
Quantitative analysis will be executed from a time-intensity curve generated from a region of interest and from left and right talami.
Peak enhancement will be measured as maximum echo power on time-intensity curve.
|
1 day
|
Quantitative assessment of neonatal brain perfusion time to peak using calculated time-intensity curve of enhancement in brain CEUS at term
Time Frame: 1 day
|
Quantitative analysis will be executed from a time-intensity curve generated from a region of interest and from left and right talami.
Time to peak will be measured in seconds in time-intensity curve.
|
1 day
|
Quantitative assessment of neonatal brain perfusion volume using calculated time-intensity curve of enhancement in brain CEUS at term
Time Frame: 1 day
|
Quantitative analysis will be executed from a time-intensity curve generated from a region of interest and from left and right talami.
Area under the curve reporting total enhancement volume from time-intensity curve.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neonatal brain perfusion assessed with time-intensity curves of contrast enhanced ultrasound compared with brain magnetic resonance asl perfusion imaging
Time Frame: 1 day
|
Time-intensity curves of CEUS and MRI ASL-perfusion studies will be performed comparing time to peak, peak enhancement, wash-in and wash-out curves and mean transit times on different imaging methods.
Assessment will be done in correlation with clinical information.
|
1 day
|
Qualitative assessment of neonatal brain elasticity using ultrasound-guided shear wave elastography
Time Frame: 1 day
|
Quantitative analysis of repeated US-SWE measurements on both hemispheres of thalami and areas of interest estimated by brain ultrasound and elastography.
Tissue elasticity will be reported in kilopascals, comparing the findings of thalami and regions of interest on the left and on the right.
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tiina Laurikainen, Turku University Hospital
- Study Director: Riitta Parkkola, Turku University Hospital
- Study Chair: Vilhelmiina Parikka, Turku University Hospital
- Study Chair: Jussi Hirvonen, Turku University Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TL16102021.1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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