Evaluating Sonazoid for Liver Imaging in Children
A Phase 4, Open-Label, Non-randomised, Multicentre Study to Evaluate Safety and Efficacy of Intravenous Administration of Sonazoid™ for Contrast-Enhanced Ultrasound Liver Imaging in Paediatric Patients
This study is testing if a special contrast agent called Sonazoid can help doctors get better ultrasound images of liver problems in children to improve diagnosis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | GE Healthcare Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 6 sites (München and 5 other locations) |
| Trial ID | NCT06639828 on ClinicalTrials.gov |
What this trial studies
This Phase 4, open-label, non-randomised, multicentre study aims to assess the safety and efficacy of Sonazoid, a contrast agent, for enhancing ultrasound imaging of focal liver lesions (FLL) in paediatric patients. The study will enroll at least 50 children under 18 years old who have confirmed untreated FLLs, with imaging conducted at multiple centers across Europe. Participants will undergo both unenhanced and contrast-enhanced ultrasound examinations, with the results evaluated by independent readers against established diagnostic standards. The goal is to improve early detection and differentiation of benign and malignant liver tumors in children.
Who should consider this trial
Good fit: Ideal candidates are children under 18 years with at least one untreated focal liver lesion confirmed by recent imaging.
Not a fit: Patients with no confirmed focal liver lesions or those who have previously received treatment for liver tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early diagnosis of liver tumors in children, potentially enhancing treatment outcomes.
How similar studies have performed: Other studies have shown promise in using contrast-enhanced ultrasound for liver imaging, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
München and 5 other locations
- Munich University Hospital — München, Germany (Not_yet_recruiting)
- Papa Giovanni XXIII Hospital — Bergamo, Italy (Not_yet_recruiting)
- Giannina Gaslini Institute — Genoa, Italy (Not_yet_recruiting)
- University Hospitals Bristol and Weston NHS Foundation Trust — Bristol, United Kingdom (Recruiting)
- King's College Hospital NHS Foundation Trust — London, United Kingdom (Recruiting)
- Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Tingting Wang
- Email: Tingting.Wang12@gehealthcare.com
- Phone: +86 21 3895 4500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.