Central Nervous System DiseasesPhase 2NCT05590884

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

A Phase 2 study testing Gadopiclenol in people with Central Nervous System Diseases and Pediatric Disorder, run by Guerbet at 11 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages Up to 23 months
Conditions the study is for: Central Nervous System Diseases, Pediatric Disorder, Body Indication
What is being tested?: Gadopiclenol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 11 sitesin 3 countries
Study dates: 21 Sep 2022to 30 Sep 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 23 months
All sexes
No healthy volunteers
Child

Main Inclusion Criteria:

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,
Patient with known or highly suspected abnormalities/ lesion(s), scheduled to undergo contrast-enhanced MRI of any body region including CNS [...]

Main Exclusion Criteria:

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,
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,
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, [...]
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 [...]

Trial locations and contacts

11 sites in 3 countries.

Country

City, postcode or hospital

11 sites in 3 countries

Poland6 sites

Szpital Uniwersytecki nr 1 im. dr Antoniego Jurasza
Bydgoszcz
Instytut Centrum Zdrowia Matki Polki
Lodz
Uniwersytecki Szpital Dzieciecy
Lublin
Kliniczny Szpital Wojewodzki Nr 2 im. Sw. Jadwigi Krolowej
Rzeszów
Uniwersyteckie Centrum Kliniczne Warszawskiego
Warsaw, 02-091
Instytut "Pomnik - Centrum Zdrowia Dziecka"
Warsaw

Other trials in Poland

Hungary3 sites

Semmelweis Egyetem
Budapest, 1094
Országos Idegtudományi Intézet
Budapest
University of Debrecen Clinical Center Pediatric Department
Debrecen

Other trials in Hungary

United States2 sites

Medical University of South Carolina
Charleston, South Carolina, 29425-8908
Cincinnatti Childrens Hospital
Cincinnati, Ohio, 45229

Other trials in United States

About this study

Official title: Gadopiclenol Pharmacokinetics, Safety and Efficacy in Pediatric Patients < 2 Years of Age

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).

Read the 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
Being tested: Gadopiclenol
Medical subject headings: Central Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GadopiclenolDrug
Also called Elucirem
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).

Study groups in NCT05590884
Study group	Role	What they receive
Age Group 1: patients aged 3 to 23 months	Experimental	One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients. Receives: Drug: Gadopiclenol
Age Group 2: patients aged 28 days to less than 3 months	Experimental	One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients. Receives: Drug: Gadopiclenol
Age Group 3: patients aged from birth to 27 days (term newborns)	Experimental	One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients. Receives: Drug: Gadopiclenol

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Curve (AUCinf)
Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg
Measured: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours)
Elimination Half-life (t1/2α)
Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg
Measured: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Terminal Half-life (t1/2β)
Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg
Measured: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Gadopiclenol Concentrations 10 Min Post-injection (C10 Min)
Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg
Measured: blood sample collection 10 minutes post-injection of gadopiclenol for analysis
Gadopiclenol Concentration 20 Min Post-injection (C20 Min)
Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg
Measured: blood sample collection 20 minutes post-injection of gadopiclenol
Gadopiclenol Concentrations 30 Min Post-injection (C30 Min)
Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg
Measured: blood sample collection 30 minutes post-injection of gadopiclenol
Clearance
Individual predicted final model parameter scaled by body weight
Measured: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Central Volume of Distribution (V1)
Individual predicted final model parameter scaled by body weight
Measured: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Inter-compartment Clearance (Q)
Individual predicted final model parameter scaled by body weight
Measured: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Peripheral Volume of Distribution (V2)
Individual predicted final model parameter scaled by body weight
Measured: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Sep 202230 Sep 2024

First posted21 Oct 2022
Study start21 Sep 2022
Primary completion30 Sep 2024
Study completion30 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Central Nervous System DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05590884
Sponsor's protocol ID: GDX-44-015
Status last verified: Oct 2025
First submitted: 18 Oct 2022
Last updated: 28 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Gadopiclenol Pharmacokinetics, Safety and Efficacy in Pediatric Patients < 2 Years of Age
ClinicalTrials.gov ID: NCT05590884
Acronym / sponsor ID: GDX-44-015
Conditions: Central Nervous System Diseases, Pediatric Disorder, Body Indication
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: GuerbetIndustry (pharma, biotech, devices)
Study start: 21 Sep 2022 (actual)
Primary completion: 30 Sep 2024 (actual)
Study completion: 30 Sep 2024 (actual)
First posted: 21 Oct 2022 (actual)
Results: Posted 28 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Age Group 1: patients aged 3 to 23 months	Experimental	Drug: GadopiclenolOne Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.
Age Group 2: patients aged 28 days to less than 3 months	Experimental	Drug: GadopiclenolOne Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.
Age Group 3: patients aged from birth to 27 days (term newborns)	Experimental	Drug: GadopiclenolOne Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.

Who may qualify

Ages: Up to 23 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GadopiclenolAlso: EluciremPatients 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).	Drug	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)

Primary outcome

Area Under the Curve (AUCinf)
Time frame: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours)
Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg
Elimination Half-life (t1/2α)
Time frame: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg
Terminal Half-life (t1/2β)
Time frame: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg
Gadopiclenol Concentrations 10 Min Post-injection (C10 Min)
Time frame: blood sample collection 10 minutes post-injection of gadopiclenol for analysis
Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg
Gadopiclenol Concentration 20 Min Post-injection (C20 Min)
Time frame: blood sample collection 20 minutes post-injection of gadopiclenol
Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg
Gadopiclenol Concentrations 30 Min Post-injection (C30 Min)
Time frame: blood sample collection 30 minutes post-injection of gadopiclenol
Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg
Clearance
Time frame: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Individual predicted final model parameter scaled by body weight
Central Volume of Distribution (V1)
Time frame: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Individual predicted final model parameter scaled by body weight
Inter-compartment Clearance (Q)
Time frame: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Individual predicted final model parameter scaled by body weight
Peripheral Volume of Distribution (V2)
Time frame: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Individual predicted final model parameter scaled by body weight

Results and safety

Results posted to the registry on 28 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Age Group 1: Patients Aged 3 to 23 Months	33	32
Age Group 2: Patients Aged 28 Days to Less Than 3 Months	2	2
Age Group 3: Patients Aged From Birth to 27 Days (Term Newborns)	1	1

Primary outcome: Area Under the Curve (AUCinf)

Time frame: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours). Geometric mean (Geometric Coefficient of Variation). Unit: h.mg/L

Measure	Age Group 1: Patients Aged 3 to 23 Months n = 33	Age Group 2: Patients Aged 28 Days to Less Than 3 Months n = 2	Age Group 3: Patients Aged From Birth to 27 Days (Term Newborns) n = 0
Value	392.3 (27.6)	493.3 (9.9)	–

Population analysed: Among the 36 patients who received an injection of gadopiclenol for MRI (Safety Set), the patient aged 0-27 days was excluded from the Per Protocol Set, due to a major deviation impacting the popPK model, therefore 35 patients were included in the population PK analysis including 33 patients aged 3-23 months and 2 patients aged 28-89 days.

Primary outcome: Elimination Half-life (t1/2α)

Time frame: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).. Geometric mean (Geometric Coefficient of Variation). Unit: h

Measure	Age Group 1: Patients Aged 3 to 23 Months n = 33	Age Group 2: Patients Aged 28 Days to Less Than 3 Months n = 2	Age Group 3: Patients Aged From Birth to 27 Days (Term Newborns) n = 0
Value	0.3 (30.3)	0.3 (30.3)	–

Primary outcome: Terminal Half-life (t1/2β)

Time frame: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).. Geometric mean (Geometric Coefficient of Variation). Unit: h

Measure	Age Group 1: Patients Aged 3 to 23 Months n = 33	Age Group 2: Patients Aged 28 Days to Less Than 3 Months n = 2	Age Group 3: Patients Aged From Birth to 27 Days (Term Newborns) n = 0
Value	1.5 (21.4)	2.1 (8.4)	–

Primary outcome: Gadopiclenol Concentrations 10 Min Post-injection (C10 Min)

Time frame: blood sample collection 10 minutes post-injection of gadopiclenol for analysis. Geometric mean (Geometric Coefficient of Variation). Unit: mg/L

Measure	Age Group 1: Patients Aged 3 to 23 Months n = 33	Age Group 2: Patients Aged 28 Days to Less Than 3 Months n = 2	Age Group 3: Patients Aged From Birth to 27 Days (Term Newborns) n = 0
Value	226.8 (15.8)	190.4 (16.2)	–

Adverse events

Time frame: Adverse events (AE) occurring from the beginning of patient's participation in the trial (Informed Consent Form signature) until the end of the participation (up to 3 months following gadopiclenol administration).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Age Group 1: Patients Aged 3 to 23 Months	8 of 33 (24.2%)	13 of 33 (39.4%)	0 of 33
Age Group 2: Patients Aged 28 Days to Less Than 3 Months	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Age Group 3: Patients Aged From Birth to 27 Days (Term Newborns)	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Limitations and caveats (from the sponsor): Due to incomplete recruitment in study GDX-44-015, with only 2 patients aged 28-89 days and none aged less than 28 days who could be included in the popPK analysis, exposure in these groups was only obtained by simulation using the final model.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Donna R Roberts, MD principal investigator

Medical University of South Carolina, Division of Neuroradiology

11 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gadopiclenol in people with Central Nervous System Diseases and Pediatric Disorder, run by Guerbet at 11 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Poland, Hungary, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Curve (AUCinf) (time frame: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05590884.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025; AzTrials last refreshed its copy on 8 Nov 2026.