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Tests treatment safety and results for Focal Liver Lesions
Official title Phase 4 Paediatric Study to Evaluate Sonazoid Safety and Efficacy for Contrast-Enhanced Ultrasound Liver Imaging
ClinicalTrials.gov ID: NCT06639828
What this study is testing
- What it's testing
- Liver tumours, 40% of which are benign, account for 1% to 4% of all solid tumours in children. The benign tumours are mainly haemangiomas, liver hamartomas, and liver cell adenomas.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 18
You may be able to join if
- 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...
- 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...
- 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...
You likely can't join if
- 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...
- 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...
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- München, Germany
- Bergamo, Italy
- Genoa, Italy
- Bristol, United Kingdom
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include München, Germany; Bergamo, Italy; Genoa, Italy; Bristol, United Kingdom; London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.