Sonazoid™ for Contrast-Enhanced Ultrasound Liver Imaging in PaediatricPatients
Research type
Research Study
Full title
A Phase 4, Open-Label, Non-randomized, Multicenter Study to Evaluate Safety and Efficacy of Intravenous Administration of Sonazoid™ for Contrast-Enhanced Ultrasound Liver Imaging in Paediatric Patients.
IRAS ID
1007450
Contact name
Meghna Gill
Contact email
Sponsor organisation
GE HealthCare Ltd.
Eudract number
2023-505569-95
ISRCTN Number
ISRCTN17927667
Research summary
This study will be conducted at hospital sites in Europe and will enrol patients below the age of 18 years, who have been diagnosed with one or more untreated abnormal masses in the liver (called a Focal Liver Lesion (FLL). If a patient has multiple abnormal masses, the study doctor must select one that will be referred to as “the target lesion” at his/her discretion. The diagnosis of benign or malignant for the target lesion of interest will be established by the study doctors using all available clinical information, including the results of biopsy (tissue sample taken from the mass), if available, and the imaging procedures (contrast enhanced CT or contrast enhanced MRI).
After an initial unenhanced (pre-contrast) ultrasound (US) examination of the target lesion, a single dose of Sonazoid™, dosed according to body weight, will be injected into a vein of the patient and a Contrast Enhanced Ultrasound (CEUS) examination will be performed, and images for both these US examinations will be collected.
The unenhanced US and CEUS images will be assessed by 3 independent readers, who are not allowed to know the patient identification or clinical diagnosis for the target lesion provided by the study doctors, following standard guidelines for ultrasound interpretation. The diagnoses made by the independent readers, based on the unenhanced US and the CEUS results, will be compared with the reference diagnosis for the target lesion made by the study doctors. This comparison will allow sensitivity and specificity information about the unenhanced US and CEUS images to be calculated.
Clinical safety data, including blood pressure, heart rate, breathing rate, oxygen levels in blood, blood and urine analysis results, physical examination and injection site observations will be collected throughout the study. Safety will also be evaluated by monitoring the patients for the occurrence of Adverse Events.
REC name
London - Hampstead Research Ethics Committee
REC reference
23/LO/0878
Date of REC Opinion
15 Dec 2023
REC opinion
Further Information Favourable Opinion