New ultrasound dye could help detect childhood liver cancer earlier
NCT ID NCT06639828
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a special ultrasound dye called Sonazoid can help doctors tell the difference between harmless and cancerous liver growths in children. About 50 children under 18 with a liver mass will get the dye through an IV and have an ultrasound. The goal is to see if this method is accurate and safe, potentially offering a faster, radiation-free way to diagnose liver tumors early.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Up to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * The subject is \<18 years of age on the day of consent. * The subject has at least 1 untreated FLL with ≤8 lesions (excluding cysts), with ≤8 cm confirmed in a diagnostic examination performed in the past month (or past 3 months if the lesion was benign) and that could also be visualised when obtained via unenhanced ultrasound imaging * The subject has had a dynamic CECT or CEMRI examination within the past month or is scheduled to have one in the month following inclusion in the study, and these images are/would be available. * The subject can comply with study procedures. * Parents or legally authorised representatives have signed the Informed Consent Form approved for this study by the Independent Review Board (IRB)/Independent Ethics Committee (IEC). The form will indicate that the patient (and/or a legally acceptable representative) has been informed of all pertinent aspects of the study. Patients who are able to provide assent have signed an age-appropriate paediatric assent form * Post-menarcheal female patients must have a negative urine pregnancy test at screening and at pre-dose on the dosing day. * Post-menarcheal female patients and male patients who are sexually active with a partner of childbearing potential must be practicing abstinence or be using an effective form of birth control (See Section 8.6) for ≥30 days before being enrolled in the study * The subject has a body weight of 3 kg or greater. * The subject has a negative egg allergy test if the egg allergy status of the subject is unknown. Exclusion Criteria: * The subject has a known or suspected hypersensitivity to any of the components of Sonazoid™, including a history of allergies to eggs or egg products (i.e., manifested by full body rash, respiratory difficulty, oral or laryngeal swelling, hypotension, or shock). * The subject has an acute clinically fatal condition (i.e., the expected survival is ≤6 months). * The subject has previously received Sonazoid™ or another ultrasound contrast agent within the past 30 days. * The subject had undergone or is planning to undergo an examination with a contrast agent (i.e., iodinated x-ray contrast agent, MRI contrast agent or another ultrasound contrast agent) within the 24 hours before or after Sonazoid™ injection. * The subject has undergone or was undergoing systemic or loco-regional chemotherapy or radiation therapy * The subject is participating in another clinical trial with an unregistered medicinal product, or less than 30 days has passed since the subject completed participation in such a trial * The subject is a pregnant or lactating female. * The physician judges that a large-enough needle (24-gauge or larger) cannot be inserted. * The subject has a known right-left cardiac shunt.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Giannina Gaslini Institute
NOT_YET_RECRUITINGGenoa, 16147, Italy
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Imperial College Healthcare NHS Trust
RECRUITINGLondon, W2 1NY, United Kingdom
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King's College Hospital NHS Foundation Trust
RECRUITINGLondon, SE5 9RS, United Kingdom
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Munich University Hospital
NOT_YET_RECRUITINGMünchen, 81377, Germany
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Papa Giovanni XXIII Hospital
NOT_YET_RECRUITINGBergamo, 24127, Italy
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University Hospitals Bristol and Weston NHS Foundation Trust
RECRUITINGBristol, BS2 8BJ, United Kingdom
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