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Contrast Agent

Gadopiclenol for Pediatric Disorders

Phase 2
Waitlist Available
Led By Donna R Roberts, MD
Research Sponsored by Guerbet
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up a total of 3 blood samples per patient will be taken post-injection for pk analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Awards & highlights
No Placebo-Only Group

Summary

This trial tests how a drug affects the body in babies up to 23 months old, given intravenously before a MRI.

Who is the study for?
This trial is for children under 2 years old, including newborns and preterm infants past the neonatal period, who need a contrast-enhanced MRI scan due to suspected abnormalities. Kids with severe allergies, recent or upcoming significant medical procedures, renal insufficiency, recent chemotherapy changes, or exposure to other contrast agents are excluded.
What is being tested?
The study tests gadopiclenol's safety and how it moves through the body (pharmacokinetics) in kids up to 23 months old needing an MRI. Each child gets one dose of gadopiclenol before their scan. Researchers will monitor blood levels using a population pharmacokinetic approach.
What are the potential side effects?
Potential side effects aren't detailed here but may include reactions similar to those seen with other MRI contrast agents like mild pain at injection site, nausea or allergic reactions. Close monitoring during the trial aims to identify any adverse effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~a total of 3 blood samples per patient will be taken post-injection for pk analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
This trial's timeline: 3 weeks for screening, Varies for treatment, and a total of 3 blood samples per patient will be taken post-injection for pk analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under the Curve
Elimination half-life
Simulated concentrations at 10 minutes post injection
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Age Group 3: patients aged from birth to 27 days (term newborns)Experimental Treatment1 Intervention
One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.
Group II: Age Group 2: patients aged 28 days to less than 3 monthsExperimental Treatment1 Intervention
One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.
Group III: Age Group 1: patients aged 3 to 23 monthsExperimental Treatment1 Intervention
One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.

Find a Location

Who is running the clinical trial?

GuerbetLead Sponsor
70 Previous Clinical Trials
94,531 Total Patients Enrolled
Donna R Roberts, MDPrincipal InvestigatorMedical University of South Carolina, Division of Neuroradiology

Media Library

Gadopiclenol (Contrast Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05590884 — Phase 2
Pediatric Disorders Research Study Groups: Age Group 1: patients aged 3 to 23 months, Age Group 2: patients aged 28 days to less than 3 months, Age Group 3: patients aged from birth to 27 days (term newborns)
Pediatric Disorders Clinical Trial 2023: Gadopiclenol Highlights & Side Effects. Trial Name: NCT05590884 — Phase 2
Gadopiclenol (Contrast Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05590884 — Phase 2
~16 spots leftby Nov 2025
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