Improving Heart Scans in Children: A Study Comparing Two Contrast Agents for MRI

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacio Sant Joan De Deu

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16], Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2026-02-02

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Guerbet

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

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.

Secondary objectives 2

1. To compare the visualisation of myocardial fibrosis between gadopiclenol and gadoterate meglumine.
2. To evaluate gadopiclenol’s safety profile in cardiac MRI population.

Conditions and MedDRA coding

Cardiomyopathy, tetralogy of Fallot, or complex congenital heart disease

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

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

Exclusion criteria 6

1. An estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m² at screening
2. 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.
3. 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.
4. Acute cardiac failure, or hemodynamic instability.
5. Pregnancy.
6. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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).

Secondary endpoints 2

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio Sant Joan De Deu

Sponsor organisation

Fundacio Sant Joan De Deu

Address

Calle Santa Rosa 39-57 3a Planta

City

Esplugues De Llobregat

Postcode

08950

Country

Spain

Scientific contact point

Organisation

Fundacio Sant Joan De Deu

Contact name

Emili Inarejos Clemente

Public contact point

Organisation

Fundacio Sant Joan De Deu

Contact name

Clinical Trial Unit

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications