RecruitingRare disease

A Study Comparing Gadopiclenol and Gadoterate Meglumine for Heart MRI Scans in Children with Congenital Heart Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves children with heart conditions such as cardiomyopathy, tetralogy of Fallot, or complex congenital heart disease. Congenital heart disease refers to problems with the structure of the heart that are present from birth. The study will use two different medications called gadopiclenol and gadoterate meglumine, which are contrast agents. A contrast agent is a special substance that is injected into the body to make certain areas show up more clearly on medical images. Both medications will be given through a vein and are used during heart scans performed with an MRI machine, which is a type of imaging equipment that uses magnets and radio waves to create detailed pictures of the inside of the body.

The purpose of this study is to compare how well gadopiclenol works compared to gadoterate meglumine in producing clear images of the heart in children during MRI scans. The study will look at the quality of the images and how well doctors can see important details of the heart, including areas where the heart muscle may be damaged or scarred, which is called myocardial fibrosis. During the study, children will receive an injection of gadopiclenol during their MRI scan, and the images will be compared to previous scans that were done using gadoterate meglumine within the past year or two.

Children participating in this study will be between two and eighteen years old and will need to have a heart MRI scan as part of their regular medical care. The study will involve one MRI scan using gadopiclenol, and doctors will compare these new images with older images from a previous scan that used gadoterate meglumine. Some children may need to be sedated, which means they will be given medication to help them stay calm and still during the scan. The study will also monitor for any unwanted effects or problems that might occur after receiving the contrast agent.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment and consent
Your parent or legal guardian will be asked to provide consent for your participation in this study. If you are older than 12 years but younger than 18 years, you will also be asked to sign an assent document.
If you are of childbearing potential, a pregnancy test will be performed to confirm that you are not pregnant before you can participate.
Step 2
Pre-scan preparation
Your medical team will review your medical history, including your previous heart scan that was performed using gadoterate meglumine between 12 to 24 months ago.
Your ability to undergo the MRI (magnetic resonance imaging) scan will be assessed. The scan may be performed without sedation, or if needed, sedation may be provided according to standard protocols.
Step 3
Cardiac MRI scan with gadopiclenol
You will undergo a heart scan using an MRI machine. This is a special imaging technique that uses magnets and radio waves to create detailed pictures of your heart.
During the scan, you will receive an injection of a contrast agent called gadopiclenol into your vein. A contrast agent is a substance that helps make the images clearer and easier to read.
The dose of gadopiclenol will be 0.05 mmol per kilogram of your body weight, given as a single injection through an intravenous line (into your vein).
The scan will capture images of your heart, including areas of muscle tissue and blood flow, to assess your heart condition.
Step 4
Image quality assessment
The images obtained from your scan with gadopiclenol will be compared to the images from your previous scan that used gadoterate meglumine.
The medical team will evaluate the quality of the images, including how clearly the heart muscle and blood can be seen, and whether any areas of scarring or damage in the heart muscle can be detected.
Step 5
Safety monitoring
You will be monitored for any side effects or adverse reactions following the injection of gadopiclenol and during the scan.
Any unexpected symptoms or reactions will be recorded and assessed by the medical team.
Step 6
Study completion
After the scan and monitoring are complete, your participation in this study will be finished.
The information collected from your scan will be used to compare the performance of the two different contrast agents in children with heart conditions.

Who can join the trial?

7 criteria

You must be between 2 and 18 years old
You must need a cardiac MRI, which is a special scan that takes detailed pictures of your heart using a large magnet, and this scan requires a contrast agent, which is a special dye injected into your body to make the pictures clearer
You or your parent or legal guardian must agree to take part in this study. If you are older than 12 but younger than 18, you should also sign a form showing you agree to participate
You must have been diagnosed with one of these heart conditions: cardiomyopathy, which means your heart muscle is not working properly, tetralogy of Fallot, which is a combination of four heart defects present from birth, or complex congenital heart disease, which means you were born with complicated problems in the structure of your heart
You must be able to have an MRI scan either while awake or with the help of sedation, which means medicine that helps you relax or sleep during the scan, and this sedation must be safe and manageable for you
You must have had a previous heart MRI scan using a contrast agent called gadoterate meglumine sometime between 12 to 24 months before joining this study
If you are a female who could become pregnant, you must have a negative pregnancy test before joining the study

Who cannot join the trial?

6 criteria

The study does not list any specific reasons why a patient cannot participate
However, patients should discuss with their doctor whether this heart imaging study using contrast agents (special medicines that help create clearer pictures during scanning) is appropriate for their individual situation
General safety considerations for MRI scans (a type of medical imaging that uses magnets and radio waves to create detailed pictures of the inside of the body) may apply
Patients with certain metal implants or devices in their body may not be able to have an MRI scan safely
Patients with severe kidney problems may not be suitable for contrast agent use
Patients with known allergies to gadolinium-based contrast agents (the type of contrast medicine used in this study) should inform their doctor

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Hospital Sant Joan De Deu Barcelona
Esplugues De Llobregat, Spain

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Investigated drugs

Gadopiclenol
is a contrast agent used during MRI scans to help create clearer images of the heart. It is injected into the bloodstream before the scan and helps doctors see the heart's structure and blood vessels more clearly on the images.
Gadoterate meglumine
is also a contrast agent used during MRI scans. Like gadopiclenol, it is injected into the bloodstream to improve the quality of heart images, making it easier for doctors to identify any problems with the heart's structure or function.

Meglumine Gadoterate

What is already known about the treatment

Gadopiclenol
Gadopiclenol is a contrast agent given through injection into a vein that is used during magnetic resonance imaging (MRI) scans to help doctors see the heart and blood vessels more clearly. This medication is currently being studied in clinical trials to evaluate its effectiveness in children with heart conditions that they were born with, such as cardiomyopathy, tetralogy of Fallot, or other complex heart problems. It works by temporarily changing the magnetic properties of tissues in the body, which makes certain areas appear brighter on MRI images, allowing doctors to better identify abnormalities in the heart's structure and function. Gadopiclenol belongs to a class of medications called gadolinium-based contrast agents, which are specifically designed to improve the quality of MRI scans.
Gadoterate meglumine
Gadoterate meglumine is an injectable contrast agent that is administered into a vein to enhance the visibility of internal body structures during MRI scans. This medication is already approved and widely used in medical practice for improving the clarity of MRI images, particularly for examining the heart, blood vessels, brain, and other organs. It functions by altering the magnetic signals from body tissues, which creates better contrast between different types of tissues and helps doctors detect diseases, structural problems, or abnormalities more accurately. Gadoterate meglumine is classified as a gadolinium-based contrast agent and is considered a standard reference medication in imaging studies.

Investigated diseases

Cardiomyopathy
Cardiomyopathy is a disease of the heart muscle that affects its ability to pump blood effectively throughout the body. The heart muscle becomes weakened, thickened, or stiffened, making it harder for the heart to work properly. As the condition progresses, the heart becomes less able to maintain normal blood flow, which can lead to fluid buildup in the lungs, legs, and other parts of the body. The disease can develop gradually over time or appear suddenly. In children, cardiomyopathy may be present from birth or develop during childhood. The heart's reduced pumping ability causes symptoms such as tiredness, shortness of breath, and swelling in various body parts.
Tetralogy of Fallot
Tetralogy of Fallot is a congenital heart defect that is present at birth and consists of four abnormalities in the heart's structure. These abnormalities include a hole between the heart's lower chambers, a narrowed valve and passage leading to the lungs, a thickened right lower heart chamber, and a displaced main blood vessel. The combination of these defects causes oxygen-poor blood to mix with oxygen-rich blood, resulting in less oxygen reaching the body. Babies with this condition often have a bluish tint to their skin, lips, and fingernails due to low oxygen levels. The severity of symptoms depends on how much blood flow to the lungs is blocked. Children with this condition may experience episodes where their skin suddenly turns very blue, especially during crying or feeding.
Complex Congenital Heart Disease
Complex congenital heart disease refers to serious structural problems with the heart that are present from birth and involve multiple defects or abnormalities. These conditions affect the heart's chambers, valves, or blood vessels in ways that significantly disrupt normal blood flow through the heart and body. The heart's structure is formed incorrectly during development before birth, resulting in various combinations of defects that make the heart work inefficiently. Children with complex congenital heart disease may have blue-tinged skin, difficulty breathing, poor feeding, and slow growth. The severity and specific symptoms vary widely depending on which parts of the heart are affected and how severely. These conditions require specialized medical care from birth throughout childhood and often into adulthood.