Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

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

NCT ID NCT05590884

Diagnosis Sponsor: Guerbet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

36 people

The number who actually took part.

Started

Sep 2022

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 23 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Main Inclusion Criteria: 1. Female or male pediatric patient aged from birth to 23 months of age inclusive (term neonates for all age groups or preterm infants after the neonatal period for groups 1 or 2). The neonatal period for preterm newborns is defined as the day of birth through the expected date of delivery plus 27 days. Term is defined as ≥37 completed weeks of amenorrhea, 2. Patient with known or highly suspected abnormalities/ lesion(s), scheduled to undergo contrast-enhanced MRI of any body region including CNS \[...\] Main Exclusion Criteria: 1. Patient planned for treatment or procedure (e.g. surgery) that would prevent from obtaining the required blood samples or performing other trial procedures between the screening visit and up to one day after gadopiclenol administration, 2. Patient undergoing treatment or procedure (e.g., diuretics, clinically significant blood loss or blood transfusion) preceding or subsequent to gadopiclenol administration that would alter gadopiclenol pharmacokinetic parameters, 3. Patient with acute or chronic renal insufficiency defined as estimated Glomerular Filtration Rate (eGFR) out of age-adjusted normal value calculated based on bedside Schwartz equation, \[...\] 9\. Patient undergoing a change in chemotherapy (product or dosage) within one day prior to or one day after gadopiclenol administration, 10. Patient who received or will receive any other contrast agent for CT and/or MRI within one week prior to or one week after gadopiclenol administration, 11. Patient with contraindication for MRI such as iron metal implants (e.g., aneurysm clips, pacemaker), 12. Patient with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents \[...\]

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Body indication are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.