BridgeMD
Phase 4 Paediatric Study to Evaluate Sonazoid™ Safety and Efficacy for Contrast-Enhanced Ultrasound Liver Imaging.
EU CTIS ID: 2023-505569-95-00
What this study is testing
To evaluate the diagnostic accuracy of ultrasound images enhanced with Sonazoid™ (perflubutane microbubbles) for differentiating benign vs malignant focal liver lesions (FLL) in paediatric patients during vascular phase imaging.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 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 for malignant lesions, or 3 months for benign lesions if performed retrospectively, 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.
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 (i.e., manifested by full body rash, respiratory difficulty, oral or laryngeal swelling, hypotension, or shock), or a positive result from an egg-allergy test performed at screening. Note: If the egg-allergy status is unknown, an egg-allergy test must be performed at screening and the result must be negative.
- 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.
See the full eligibility criteria
Who can join
- 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 for malignant lesions, or 3 months for benign lesions if performed retrospectively, 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.
What rules you out
- 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), or a positive result from an egg-allergy test performed at screening. Note: If the egg-allergy status is unknown, an egg-allergy test must be performed at screening and the result must be negative.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- 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, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 EU CTIS; the study team decides eligibility.