Safer MRI scans for infants? new contrast agent studied in toddlers

NCT ID NCT05590884

Completed Diagnosis Sponsor: Guerbet Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a contrast agent called gadopiclenol in 36 infants under 2 years old who needed an MRI. The goal was to see how the drug behaves in their bodies and check for safety. The children received a single injection before their MRI, and researchers measured drug levels in the blood. This is an early step toward confirming the drug works well in very young children.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Gadopiclenol (a contrast agent used to brighten MRI images)
What this could lead to: If successful, this could confirm that gadopiclenol is safe and effective for use in very young children, improving MRI diagnosis in this age group.
What could go wrong: This is a small, early-phase study with only 36 children, so results may not apply to all infants. The drug is already approved for older children and adults, so major surprises are unlikely.

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Conditions

The condition(s) this trial relates to.

central nervous system disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BODY INDICATION CENTRAL NERVOUS SYSTEM DISEASES PEDIATRIC DISORDER

Contacts and locations

Locations

Cincinnatti Childrens Hospital

Cincinnati, Ohio, 45229, United States
Instytut "Pomnik - Centrum Zdrowia Dziecka"

Warsaw, Poland
Instytut Centrum Zdrowia Matki Polki

Lodz, Poland
Kliniczny Szpital Wojewodzki Nr 2 im. Sw. Jadwigi Krolowej

Rzeszów, Poland
Medical University of South Carolina

Charleston, South Carolina, 29425-8908, United States
Országos Idegtudományi Intézet

Budapest, Hungary
Semmelweis Egyetem

Budapest, 1094, Hungary
Szpital Uniwersytecki nr 1 im. dr Antoniego Jurasza

Bydgoszcz, Poland
University of Debrecen Clinical Center Pediatric Department

Debrecen, Hungary
Uniwersytecki Szpital Dzieciecy

Lublin, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego

Warsaw, 02-091, Poland

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