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

Condition studied

Cardiomyopathy, tetralogy of Fallot, or complex congenital heart disease

Investigational medicinal product(s)

Eligibility

Primary endpoint

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).

Endpoint detail

Quantitative assessment of late gadolinium enhancement (LGE) volume and mass, diagnostic confidence, SNR, CNR, and left ventricular function., Number of adverse events (AEs).