GADOPICLENOL for Cardiomyopathy | Tetralogy of Fallot | Complex congenital heart disease

Inclusion criteria

• {"criterion_text":"- Patients aged between 2 and 18 years old, both included, with a clinical need for contrast-enhanced cardiac MRI.\n- 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.\n- A confirmed diagnosis of cardiomyopathy, tetralogy of Fallot, or complex congenital heart disease.\n- The ability to undergo MRI either without sedation or with sedation following manageable protocols.\n- Patients must have had a previous cardiac MRI using gadoterate meglumine between 12 to 24 months before recruitment.\n- People of childbearing potential (POCBP) will be included after a negative highly sensitive pregnancy test. See the Schedule of Assessments (SoA)."}

Exclusion criteria

• {"criterion_text":"- An estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m² at screening\n- 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.\n- 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.\n- Acute cardiac failure, or hemodynamic instability.\n- Pregnancy.\n- 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."}

Primary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Assessment of overall image quality including myocardium-to-blood pool contrast and detection of myocardial fibrosis using diagnostic confidence scores and quantitative image metrics: contrast-to-noise ratio (CNR) and signal-to-noise ratio (SNR)."}

Secondary endpoints

• {"endpoint_text":"- Quantitative assessment of late gadolinium enhancement (LGE) volume and mass, diagnostic confidence, SNR, CNR, and left ventricular function.","definition_or_measurement_approach":"Quantitative measurement of LGE volume and mass; assessment of diagnostic confidence; measurement of SNR and CNR; evaluation of left ventricular function (e.g., ejection fraction/volumetry) as per imaging analysis protocols."}
• {"endpoint_text":"- Number of adverse events (AEs).","definition_or_measurement_approach":"Counting and recording of adverse events (AEs) observed/reported during study procedures and monitoring, classified per standard safety reporting."}

Spain

Earliest CTIS Part Ii Submission Date

13-11-2025

Latest Decision Or Authorization Date

02-02-2026

Processing Time Days

81

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Fundacio Sant Joan De Deu

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain