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Improving Heart Scans in Children: A Study Comparing Two Contrast Agents for MRI
EU CTIS ID: 2025-524029-41-00
What this study is testing
To compare the image quality and diagnostic performance of gadopiclenol (0.05 mmol/kg) against gadoterate meglumine (0.1 mmol/kg) in paediatric cardiac MRI.
- Therapeutic confirmatory (Phase III)
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
- Patients aged between 2 and 18 years old, both included, with a clinical need for contrast-enhanced cardiac MRI.
- Consent to participate in the study. For patients under the age of 18 (or age of consent), parent(s)/legal guardian(s) of the patient must give their consent to enrol the patient in the study. Patients >12 years and < 18 years old should sign the approved assent document.
- A confirmed diagnosis of cardiomyopathy, tetralogy of Fallot, or complex congenital heart disease.
- The ability to undergo MRI either without sedation or with sedation following manageable protocols.
- Patients must have had a previous cardiac MRI using gadoterate meglumine between 12 to 24 months before recruitment.
- People of childbearing potential (POCBP) will be included after a negative highly sensitive pregnancy test. See the Schedule of Assessments (SoA).
You likely can't join if
- An estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m² at screening
- Known hypersensitivity to gadolinium-based contrast agents. Hypersensibility to any component (active ingredients or excipients) of the investigational drugs. See section 6.1 of the SmPC.
- Non-MRI-compatible implants or devices. The usual precautions for MRI examination must be applied, such as exclusion of patients with pacemakers, ferromagnetic vascular clips, infusion pumps, nerve stimulators, cochlear implants, or suspected intracorporal metallic foreign bodies, particularly in the eye.
- Acute cardiac failure, or hemodynamic instability.
- Pregnancy.
- Breastfeeding during the next 24h after treatment. Gadolinium-containing contrast agents are excreted into breast milk in very small amounts. At clinical doses, no effects on the infant are anticipated due to the small amount excreted in milk and poor absorption from the gut. Continuing or discontinuing breast feeding for a period of 24 hours after administration of Elucirem, should be at the discretion of the doctor and breast-feeding mother.
The study team makes the final eligibility decision.
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, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
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.