Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age

NCT ID: NCT05590884

Last Updated: 2025-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-21
• Study Completion Date: 2024-09-30

Brief Summary

This Phase II open-label, uncontrolled, multicenter trial is designed to investigate the pharmacokinetic (PK) profile of gadopiclenol in plasma, in pediatric patients aged up to 23 months inclusive (term neonates or preterm infants after the neonatal period), using a population PK approach.

Primary objective is to evaluate the PK profile of gadopiclenol in plasma following single intravenous injection of 0.05 mmol/kg body weight (BW) in pediatric population aged up to 23 months (inclusive) scheduled for a contrast-enhanced MRI examination of any body region including central nervous system (CNS).

Detailed Description

Three age groups are defined:

• Group 1: patients aged 3 to 23 months (inclusive)
• Group 2: patients aged 28 days to less than 3 months;
• Group 3: patients aged from birth to 27 days (term newborns).

At study set-up, the inclusions started with the oldest patients in group 1 and using an age-down staggered approach.

The decision to start the inclusions in group 2 was taken by the Trial Safety Review Board based on safety assessment over one-day period after injection of the first 13 patients in group 1.

According to the protocol version 4 (amendments 2 & 3), the age-down staggered approach was discontinued to allow the inclusions in Group 3 (patients aged from birth to 27 days), simultaneously to inclusions in group 1 and group 2.

A total of 3 blood samples per patient were taken post-injection for PK analysis.

Conditions

Central Nervous System Diseases; Pediatric Disorder; Body Indication

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Age Group 1: patients aged 3 to 23 months

One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.

Group Type: EXPERIMENTAL

Gadopiclenol

Intervention Type: DRUG

Patients will receive a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol will be administered at a dose of 0.05 mmol/kg BW (0.1 mL/kg BW).

Age Group 2: patients aged 28 days to less than 3 months

One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.

Group Type: EXPERIMENTAL

Gadopiclenol

Intervention Type: DRUG

Patients will receive a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol will be administered at a dose of 0.05 mmol/kg BW (0.1 mL/kg BW).

Age Group 3: patients aged from birth to 27 days (term newborns)

One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.

Group Type: EXPERIMENTAL

Gadopiclenol

Intervention Type: DRUG

Patients will receive a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol will be administered at a dose of 0.05 mmol/kg BW (0.1 mL/kg BW).

Interventions

Gadopiclenol

Patients will receive a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol will be administered at a dose of 0.05 mmol/kg BW (0.1 mL/kg BW).

Intervention Type: DRUG

Other Intervention Names

Elucirem

Eligibility Criteria

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 [...]

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 [...]

• Maximum Eligible Age: 23 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guerbet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donna R Roberts, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina, Division of Neuroradiology

Locations

Cincinnatti Childrens Hospital

Cincinnati, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Semmelweis Egyetem

Budapest, , Hungary

Országos Idegtudományi Intézet

Budapest, , Hungary

University of Debrecen Clinical Center Pediatric Department

Debrecen, , Hungary

Szpital Uniwersytecki nr 1 im. dr Antoniego Jurasza

Bydgoszcz, , Poland

Instytut Centrum Zdrowia Matki Polki

Lodz, , Poland

Uniwersytecki Szpital Dzieciecy

Lublin, , Poland

Kliniczny Szpital Wojewodzki Nr 2 im. Sw. Jadwigi Krolowej

Rzeszów, , Poland

Uniwersyteckie Centrum Kliniczne Warszawskiego

Warsaw, , Poland

Instytut "Pomnik - Centrum Zdrowia Dziecka"

Warsaw, , Poland

Countries

United States; Hungary; Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

GDX-44-015

Identifier Type: -

Identifier Source: org_study_id