Phase 4 Paediatric Study to Evaluate Sonazoid Safety and Efficacy for Contrast-Enhanced Ultrasound Liver Imaging
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Phase
Phase 4
Status
Recruiting
Study type
Interventional
Design
Na · None · Diagnostic
Enrollment
50estimated
Sites
6
Countries
Germany, Italy, United Kingdom
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-01-20 | actual | When the study began enrolling |
| Primary completion | 2026-07-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-10-31 | estimated | The whole study's end, after follow-up |
| First posted | 2024-10-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Focal Liver Lesions
Intervention
- Diagnostic test: Contrast-Enhanced Ultrasound
Primary outcomes
what the primary-completion date above is the date OFAccuracy of Sonazoid-enhanced ultrasound at imaging focal liver lesions during the vascular phase of imaging
measured Images to be captured during the studies CEUS examination [approximately 5 seconds prior to bolus injection, up to 4-minutes post injection for the vascular phase] and blinded image evaluations shall be executed remotely at a central lab
Sensitivity of Sonazoid-enhanced ultrasound at imaging focal liver lesions during the vascular phase of imaging
measured Images to be captured during the studies CEUS examination [approximately 5 seconds prior to bolus injection, up to 4-minutes post injection for the vascular phase] and blinded image evaluations shall be executed remotely at a central lab
Specificity of Sonazoid-enhanced ultrasound at imaging focal liver lesions during the vascular phase of imaging
measured Images to be captured during the studies CEUS examination [approximately 5 seconds prior to bolus injection, up to 4-minutes post injection for the vascular phase] and blinded image evaluations shall be executed remotely at a central lab
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