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
interventional
N/A
1 country
1
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 20, 2025
Actual (reported)To measure the overall image quality, including myocardium-to-blood pool contrast, and the detection of myocardial fibrosis using gadopiclenol vs. gadoterate meglumine through the diagnostic confidence, contrast-to-noise ratio (CNR), and signal-to-noise ratio (SNR).
Quantitative assessment of late gadolinium enhancement (LGE) volume and mass, diagnostic confidence, SNR, CNR, and left ventricular function.
Number of adverse events (AEs).
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Formulated product
Elucirem 0.5 mmol/mL solution for injection
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Elucirem 0.5 mmol/mL solution for injection
Named ingredient: gadopiclenol
View registry recordHospital Sant Joan De Deu Barcelona
Esplugues De Llobregat, 08950, Spain
Clinical Trial Unit
First Submitted
October 20, 2025
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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