Focal liver lesions Cancer
Conditions
Interventions
This Phase IV, open-label, non-randomised, multicentre prospective study in Europe will enrol paediatric patients who are presenting with =1 confirmed untreated target FLL. If a patient has multiple F
Sponsors
GE HealthCare Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject is <18 years of age on the day of consent 2. The subject has at least 1 untreated FLL with =8 lesions (excluding cysts), with =10 cm confirmed in a diagnostic examination performed in the past month (or past 3 months if the lesion was benign) and that could be visualised by unenhanced (not contrast-enhanced) US imaging. 3. The subject has had a dynamic CECT or CEMRI examination within the past month or was scheduled to have one in the month following inclusion in the study and the original images (or copies thereof) are/would be available. 4. The subject can comply with study procedures. 5. Parents or legally authorised representatives have signed the Informed Consent Form approved for this study by the Ethics Committee. 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. 6. Post-menarcheal female patients must have a negative urine pregnancy test at screening and at pre-dose on the dosing day. 7. 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.
Exclusion criteria
Exclusion criteria: 1. 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). 2. The subject has an acute clinically fatal condition (i.e., the expected survival is =6 months). 3. The subject has previously received Sonazoid™ or another ultrasound contrast agent within the past 30 days. 4. The subject has undergone or was undergoing systemic or loco-regional chemotherapy or radiation therapy. 5. 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. 6. The subject is a pregnant or lactating female or is a female of childbearing potential not using an acceptable form of birth control (negative urine pregnancy test also required). 7. The physician judges that a large-enough needle (24-gauge or larger) cannot be inserted.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Accuracy, sensitivity and specificity of the diagnosis (benign or malignant FLL) based on the Sonazoid™-enhanced imaging by vascular phase imaging, as compared with the unenhanced ultrasound imaging, when the baseline diagnosis is used as the reference standard. 2. Accuracy, sensitivity and specificity of the diagnosis (benign or malignant FLL) based on the Sonazoid™-enhanced imaging by vascular phase and Kupffer phase imaging, as compared with the unenhanced ultrasound imaging, when the baseline diagnosis is used as the reference standard. 3. The difference in the diagnostic confidence score for the unenhanced ultrasound imaging and that for the Sonazoid™-enhanced ultrasound imaging based on the vascular phase. Each of the outcome measures are based upon the independent blinded read of the Sonazoid™-enhanced imaging for lesion differentiation. The independent blinded reads are to be conducted in a summative manner at the end of the study. According to the current study timelines the blinded reads shall be approximately mid-December (accounting for a last subject scan date of approximately 26/11/2025). | — |
Primary
| Measure | Time frame |
|---|---|
| The accuracy, sensitivity and specificity of the diagnosis based on the independent blinded read of the Sonazoid™-enhanced imaging for lesion differentiation (benign or malignant FLLs) during vascular phase imaging. The WFUMB-EFSUMB guidelines for interpreting CEUS of the liver in adults shall be used for interpreting the images and the subject’s baseline diagnosis (well-established by CECT, CEMRI or biopsy) will be used as the reference diagnosis/standard of truth. | — |
Countries
England, Germany, United Kingdom
Contacts
Public ContactMeghna Gill
Outcome results
None listed