Evaluating Sonazoid for Liver Imaging in Children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• 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

Study contacts

• Study coordinator: Tingting Wang
• Email: Tingting.Wang12@gehealthcare.com
• Phone: +86 21 3895 4500

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• AI-assisted imaging for diagnosing and managing focal liver lesions

  Researchers are testing whether AI-powered imaging can help doctors better diagnose focal liver lesions in adults undergoing CT scans.

  Recruiting at 2 sites Sun Yat-sen University · Guangzhou, Guangdong and 1 other locations · NCT07926672

• Prophylactic extrahepatic biliary drainage to prevent bile leakage after liver resection in children

  In kids who need liver removal and are at high risk for bile leakage, this study tests whether adding a biliary drainage procedure during surgery can prevent leaks within 90 days.

  Recruiting Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Moscow · NCT07867522

• Heart rate and respiration monitoring device: performance and usability in patients of all ages

  We’re testing a new physiological monitor to see how well it works and how easy it is to use for patients from newborns to seniors.

  Recruiting GE Healthcare · Espoo · NCT07893405

• New flutemetamol F18 formulation to see if it works as well as current for brain amyloid imaging

  Researchers are testing a new flutemetamol F18 formulation (GE-287) to see if it identifies brain amyloid as accurately as the current formulation in people 50 and older who are undergoing amyloid PET scans for cognitive decline.

  Recruiting at 5 sites Phase 2 GE Healthcare · Aventura, Florida and 5 other locations · NCT07873463

• Omni 128 cm PET/CT imaging system: comparing new scanner with standard PET/CT

  This study tests a new Omni 128 cm PET/CT scanner by having adults with a planned clinical PET/CT also undergo an extra research scan to compare image quality.

  Recruiting GE Healthcare · Stanford, California · NCT07857161

• Automated Non-Invasive Blood Pressure: Tracking Blood Pressure Changes Using SpO2 Data

  This study tests an algorithm that estimates blood pressure changes using data from an SpO2 sensor in patients in the OR, PACU, or ICU who already have invasive BP measured as part of standard care.

  Recruiting GE Healthcare · Helsinki and 1 other locations · NCT07790458

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.