Safety and Effectiveness of Intravenous Sonazoid for Contrast-Enhanced Liver Ultrasound in Children with Focal Liver Lesions

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What is this study about?

This study focuses on evaluating Sonazoid™ (perflubutane microbubbles) for imaging focal liver lesions in children and adolescents under 18 years of age. Focal liver lesions are abnormal areas or growths in the liver tissue that can be either benign (non-cancerous) or malignant (cancerous). The purpose of the study is to assess how accurately Sonazoid™ can help doctors distinguish between benign and malignant liver lesions when used during contrast-enhanced ultrasound imaging.

Contrast-enhanced ultrasound is a technique where special contrast agents like Sonazoid™ are injected into the bloodstream to improve the visibility of internal organs and blood vessels during an ultrasound examination. During the study, participants will receive Sonazoid™ intravenously (through a vein) while undergoing ultrasound imaging of their liver. The images will be taken during different phases including the vascular phase (when the contrast agent is flowing through blood vessels) and the Kupffer phase (when the contrast agent is taken up by special cells in the liver).

The study will compare the images obtained with Sonazoid™ to those from regular ultrasound without contrast, as well as to the participant’s baseline diagnosis established through other imaging methods like contrast-enhanced computed tomography (CECT) or contrast-enhanced magnetic resonance imaging (CEMRI). Participants will be monitored for safety for 72 hours after receiving Sonazoid™.

1 Initial Ultrasound Examination

You will undergo an initial ultrasound examination without contrast to visualize your liver lesion(s). This will serve as a baseline for comparison with later contrast-enhanced images.

The ultrasound is a non-invasive imaging procedure that uses sound waves to create pictures of the inside of your body.

2 Sonazoid™ Administration

You will receive an intravenous (IV) injection of Sonazoid™, which contains perflubutane microbubbles. These are tiny bubbles that help enhance the ultrasound images of your liver.

The Sonazoid™ will be administered through a small needle inserted into a vein, typically in your arm.

The dosage will be determined by your doctor based on your age and weight.

3 Contrast-Enhanced Ultrasound Imaging – Vascular Phase

Immediately after receiving Sonazoid™, you will undergo ultrasound imaging during what’s called the vascular phase. This shows how blood flows through the liver lesion(s).

This imaging helps doctors determine whether your liver lesion(s) are benign (non-cancerous) or malignant (cancerous).

You will need to lie still during this procedure to ensure clear images.

4 Contrast-Enhanced Ultrasound Imaging – Kupffer Phase

Following the vascular phase, imaging will continue during what’s called the Kupffer phase. This typically occurs 10-15 minutes after the injection.

The Kupffer phase shows how the contrast agent interacts with special cells in your liver called Kupffer cells, which can provide additional information about your liver lesion(s).

5 Post-Procedure Monitoring

After the imaging is complete, you will be monitored for any immediate reactions to the contrast agent.

Your injection site will be checked for any redness, swelling, or discomfort.

6 Follow-up Assessments

You will undergo physical examinations, vital sign measurements, and possibly blood and urine tests during the study period.

These assessments will help monitor your safety during the trial.

7 Final Follow-up

Your participation in the study will end 72 hours (3 days) after receiving the Sonazoid™ injection.

During this period, any side effects or adverse events you experience will be recorded.

A final safety assessment may be conducted at the end of this 72-hour period.

Who Can Join the Study?

The patient must be under 18 years old on the day they give consent.
The patient must have at least 1 untreated focal liver lesion (a localized abnormal area in the liver), with no more than 8 lesions in total (excluding cysts).
Each lesion must be no larger than 8 cm and must have been confirmed in a diagnostic test done within the past month (or past 3 months if the lesion was non-cancerous).
The lesion(s) must be visible on regular ultrasound imaging (without contrast).
The patient must have had or be scheduled to have a special CT or MRI scan with contrast (which helps better visualize the lesions) within the appropriate timeframe, and these images must be available.
The patient must be able to follow all study procedures.
Parents or legal guardians must sign the Informed Consent Form approved for this study.
Patients who are able to understand must also sign an age-appropriate assent form.
Female patients who have started menstruation must have a negative pregnancy test at screening and before receiving the study medication.
Sexually active patients must either practice abstinence or use effective birth control for at least 30 days before enrolling in the study.

Who Cannot Join the Study?

Age below 1 year or above 17 years
Patient or guardian unable to provide informed consent
Pregnancy or breastfeeding
Known allergy to perflubutane or other components of Sonazoid™ (the contrast agent used in the study)
Severe heart conditions like right-to-left shunts, severe pulmonary hypertension (high blood pressure in the lungs), or uncontrolled hypertension (high blood pressure)
Recent acute heart problems such as heart attack or unstable chest pain
Severe respiratory disorders (serious breathing problems)
Previous severe reaction to any contrast agent used in medical imaging
Known or suspected liver cancer that has already been diagnosed with certainty
Previous liver surgery that might affect the study results
Recent participation in another clinical trial that could interfere with this study
Any condition that the study doctor believes would make it unsafe for you to participate

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
IRCCS Istituto Giannina Gaslini	Genoa	Italy
Kxucjpyh dpn Uqucxkkvhjsw Mjbximzn Aqg	Munich	Germany
Ahijelc Okdjdxohsgt Pryq Gnduorzd Xrksz	Bergamo	Italy

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	30.07.2025
Italy	Not yet recruiting	30.07.2025

Trial locations

Investigated drugs:

Perflubutane

The medication involved in this clinical trial is:

Sonazoid™ (perflubutane microbubbles) is a contrast agent used in ultrasound imaging of the liver. It is given by intravenous (through the vein) injection. When injected into the bloodstream, the microbubbles in Sonazoid™ enhance the ultrasound images, making it easier to see blood flow patterns in the liver. This helps doctors better distinguish between benign (non-cancerous) and malignant (cancerous) focal liver lesions in children.

Focal Liver Lesion A focal liver lesion (FLL) is an abnormal growth or mass within the liver tissue that differs from the surrounding normal liver parenchyma. These lesions can be either benign (non-cancerous) or malignant (cancerous) in nature. Focal liver lesions encompass various types including hepatocellular carcinoma (HCC), metastases from other primary cancers, hemangiomas (benign vascular tumors), focal nodular hyperplasia (FNH), and areas of focal fatty infiltration or sparing. The progression of these lesions varies significantly depending on their type, with benign lesions typically growing slowly or remaining stable, while malignant lesions tend to progress more rapidly. Lesions can be asymptomatic, especially when small, and are often discovered incidentally during imaging performed for other reasons.

Trial ID:

2023-505569-95-00

Protocol code:

GE-045-401

NCT ID:

NCT06639828

Trial Phase:

Human Pharmacology (Phase I) – Other

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Safety and Effectiveness of Intravenous Sonazoid for Contrast-Enhanced Liver Ultrasound in Children with Focal Liver Lesions

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?