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Taking people in SpainPhase 3

Comparing two MRI contrast agents for heart scans in children with heart conditions

Compares gadopiclenol with gadoterate meglumine in heart MRI of children with heart conditions.

Key facts

Who runs it
Fundacio Sant Joan De Deu
Where
Esplugues de Llobregat, SpainSee the site
Registry title
Improving Heart Scans in Children: A Study Comparing Two Contrast Agents for MRI
Status
Recruiting
Phase
Phase 3
People taking part
30 people, planned
Started
22 Jun 2026
Expected to end
1 Mar 2027
Type of study
Interventional
Record updated
2 February 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children aged 2 to 18 with cardiomyopathy, tetralogy of Fallot or complex congenital heart disease who need a heart MRI with contrast dye. It compares the image quality of gadopiclenol with gadoterate meglumine.

Age
2 to 18 years (both included).
Sex
All sexes can join.
Disease stage
A confirmed diagnosis of cardiomyopathy, tetralogy of Fallot, or complex congenital heart disease. A medical need for a heart MRI with contrast dye.
Earlier treatment
Must have had a heart MRI with gadoterate meglumine 12 to 24 months before joining.
Biomarker or test result
People who could become pregnant need a negative highly sensitive pregnancy test.

Main reasons for not taking part

  • Kidney filtration (eGFR) below 60 mL/min/1.73 m² at screening.
  • Known allergy to gadolinium-based contrast dyes or to any part of the study drugs.
  • Implants or devices not safe in MRI, such as pacemakers, cochlear implants or metal in the body.
  • Sudden heart failure or unstable blood pressure and circulation.
  • Pregnancy, or breastfeeding in the 24h after the study drug.

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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
  • An estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m² at screening
  • 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

Where in Spain

  • Hospital Sant Joan De Deu BarcelonaEsplugues de Llobregat, SpainTaking people

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
A Pilot Study on the Use of Gadopiclenol for Enhanced Cardiac MRI in Children with Congenital Heart Conditions: A self-controlled, non-randomised, open-label study to compare the image quality and diagnostic performance of gadopiclenol versus gadoterate meglumine
Plain-language title
Comparing two MRI contrast agents for heart scans in children with heart conditionsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
2 February 2026