Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Contrast Enhanced Ultrasound and Elastography of the Preterm Brain

ID
Name
TL16102021.1
Description
The aim of the study is to investigate levels of brain perfusion and elasticity in preterm neonates when they reach the estimated due date and to compare the data with magnetic resonance imaging at term. Contrast enhanced ultrasound (sulphur hexafluoride) and ultrasound-assisted elastography will be used to evaluate the state of brain perfusion with ultrasound. Different appropriate imaging sequences will be used regarding MRI, including asl-perfusion. Neonates recruited from the Neonatal Intensive Care Unit (NICU) of Turku University Hospital will be recruited.
Trial arms
Trial start
2023-05-01
Estimated PCD
2029-07-01
Trial end
2029-12-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
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
Arms:
Preterm neonates
Sulfur Hexafluoride
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.
Arms:
Preterm neonates
Other names:
SonoVue
Size
100
Primary endpoint
Quantitative assessment of neonatal brain perfusion using calculated time-intensity curve of enhancement in brain CEUS at term
1 day
Quantitative assessment of neonatal brain peak enhancement using calculated time-intensity curve of enhancement in brain CEUS at term
1 day
Quantitative assessment of neonatal brain perfusion time to peak using calculated time-intensity curve of enhancement in brain CEUS at term
1 day
Quantitative assessment of neonatal brain perfusion volume using calculated time-intensity curve of enhancement in brain CEUS at term
1 day
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-04-25

1 organization

1 product

1 indication

Organization
Turku University Hospital
Product
Sulfur Hexafluoride
Indication
Premature Birth