Trial Outcomes & Findings for Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age (NCT NCT05590884)

Last Updated: 2025-10-28

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

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)

Results posted on

2025-10-28

Participant Flow

Participant milestones

Participant milestones
Measure	Age Group 1: Patients Aged 3 to 23 Months One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg was injected in all patients. Gadopiclenol: Patients received a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol was 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 was injected in all patients. Gadopiclenol: Patients received a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol was 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 was injected in all patients. Gadopiclenol: Patients received a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol was administered at a dose of 0.05 mmol/kg BW (0.1 mL/kg BW).
Overall Study STARTED	33	2	1
Overall Study COMPLETED	32	2	1
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Age Group 1: Patients Aged 3 to 23 Months One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg was injected in all patients. Gadopiclenol: Patients received a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol was 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 was injected in all patients. Gadopiclenol: Patients received a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol was 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 was injected in all patients. Gadopiclenol: Patients received a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol was administered at a dose of 0.05 mmol/kg BW (0.1 mL/kg BW).
Overall Study Withdrawal by Subject	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Age Group 1: Patients Aged 3 to 23 Months n=33 Participants One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg was injected in all patients. Gadopiclenol: Patients received a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol was 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 n=2 Participants One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg was injected in all patients. Gadopiclenol: Patients received a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol was 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) n=1 Participants One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg was injected in all patients. Gadopiclenol: Patients received a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol was administered at a dose of 0.05 mmol/kg BW (0.1 mL/kg BW).	Total n=36 Participants Total of all reporting groups
Age, Continuous	13.11 months STANDARD_DEVIATION 6.22 • n=5 Participants	1.94 months STANDARD_DEVIATION 0.14 • n=7 Participants	0.8 months STANDARD_DEVIATION NA • n=5 Participants	12.15 months STANDARD_DEVIATION 6.77 • n=4 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	18 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	18 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	35 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	36 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Hungary	10 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	12 participants n=4 Participants
Region of Enrollment United States	4 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	5 participants n=4 Participants
Region of Enrollment Poland	19 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	19 participants n=4 Participants
Weight	9.40 kilogram STANDARD_DEVIATION 2.18 • n=5 Participants	5.10 kilogram STANDARD_DEVIATION 0.28 • n=7 Participants	4.50 kilogram STANDARD_DEVIATION NA • n=5 Participants	9.03 kilogram STANDARD_DEVIATION 2.44 • n=4 Participants

PRIMARY outcome

Timeframe: 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)

Population: 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.

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

Outcome measures

Outcome measures
Measure	Age Group 1: Patients Aged 3 to 23 Months n=33 Participants Patients aged 3-23 months who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).	Age Group 2: Patients Aged 28 Days to Less Than 3 Months n=2 Participants Patients aged 28-89 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).	Age Group 3: Patients Aged From Birth to 27 Days (Term Newborns) Patients aged from birth to 27 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).
Area Under the Curve (AUCinf)	392.3 h.mg/L Geometric Coefficient of Variation 27.6	493.3 h.mg/L Geometric Coefficient of Variation 9.9	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Age Group 1: Patients Aged 3 to 23 Months n=33 Participants Patients aged 3-23 months who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).	Age Group 2: Patients Aged 28 Days to Less Than 3 Months n=2 Participants Patients aged 28-89 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).	Age Group 3: Patients Aged From Birth to 27 Days (Term Newborns) Patients aged from birth to 27 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).
Elimination Half-life (t1/2α)	0.3 h Geometric Coefficient of Variation 30.3	0.3 h Geometric Coefficient of Variation 30.3	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Age Group 1: Patients Aged 3 to 23 Months n=33 Participants Patients aged 3-23 months who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).	Age Group 2: Patients Aged 28 Days to Less Than 3 Months n=2 Participants Patients aged 28-89 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).	Age Group 3: Patients Aged From Birth to 27 Days (Term Newborns) Patients aged from birth to 27 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).
Terminal Half-life (t1/2β)	1.5 h Geometric Coefficient of Variation 21.4	2.1 h Geometric Coefficient of Variation 8.4	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Age Group 1: Patients Aged 3 to 23 Months n=33 Participants Patients aged 3-23 months who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).	Age Group 2: Patients Aged 28 Days to Less Than 3 Months n=2 Participants Patients aged 28-89 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).	Age Group 3: Patients Aged From Birth to 27 Days (Term Newborns) Patients aged from birth to 27 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).
Gadopiclenol Concentrations 10 Min Post-injection (C10 Min)	226.8 mg/L Geometric Coefficient of Variation 15.8	190.4 mg/L Geometric Coefficient of Variation 16.2	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Age Group 1: Patients Aged 3 to 23 Months n=33 Participants Patients aged 3-23 months who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).	Age Group 2: Patients Aged 28 Days to Less Than 3 Months n=2 Participants Patients aged 28-89 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).	Age Group 3: Patients Aged From Birth to 27 Days (Term Newborns) Patients aged from birth to 27 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).
Gadopiclenol Concentration 20 Min Post-injection (C20 Min)	161.5 mg/L Geometric Coefficient of Variation 17.2	149.8 mg/L Geometric Coefficient of Variation 13.4	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Age Group 1: Patients Aged 3 to 23 Months n=33 Participants Patients aged 3-23 months who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).	Age Group 2: Patients Aged 28 Days to Less Than 3 Months n=2 Participants Patients aged 28-89 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).	Age Group 3: Patients Aged From Birth to 27 Days (Term Newborns) Patients aged from birth to 27 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).
Gadopiclenol Concentrations 30 Min Post-injection (C30 Min)	109.4 mg/L Geometric Coefficient of Variation 22.4	116.2 mg/L Geometric Coefficient of Variation 13.3	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Age Group 1: Patients Aged 3 to 23 Months n=33 Participants Patients aged 3-23 months who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).	Age Group 2: Patients Aged 28 Days to Less Than 3 Months n=2 Participants Patients aged 28-89 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).	Age Group 3: Patients Aged From Birth to 27 Days (Term Newborns) Patients aged from birth to 27 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).
Clearance	0.128 L/h/kg Standard Deviation 0.035	0.097 L/h/kg Standard Deviation 0.004	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Age Group 1: Patients Aged 3 to 23 Months n=33 Participants Patients aged 3-23 months who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).	Age Group 2: Patients Aged 28 Days to Less Than 3 Months n=2 Participants Patients aged 28-89 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).	Age Group 3: Patients Aged From Birth to 27 Days (Term Newborns) Patients aged from birth to 27 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).
Central Volume of Distribution (V1)	0.176 L/kg Standard Deviation 0.033	0.214 L/kg Standard Deviation 0.03	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Age Group 1: Patients Aged 3 to 23 Months n=33 Participants Patients aged 3-23 months who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).	Age Group 2: Patients Aged 28 Days to Less Than 3 Months n=2 Participants Patients aged 28-89 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).	Age Group 3: Patients Aged From Birth to 27 Days (Term Newborns) Patients aged from birth to 27 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).
Inter-compartment Clearance (Q)	0.099 L/h/kg Standard Deviation 0.025	0.123 L/h/kg Standard Deviation 0.029	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Age Group 1: Patients Aged 3 to 23 Months n=33 Participants Patients aged 3-23 months who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).	Age Group 2: Patients Aged 28 Days to Less Than 3 Months n=2 Participants Patients aged 28-89 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).	Age Group 3: Patients Aged From Birth to 27 Days (Term Newborns) Patients aged from birth to 27 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).
Peripheral Volume of Distribution (V2)	0.066 L/kg Standard Deviation 0.014	0.066 L/kg Standard Deviation 0.003	—

Adverse Events

Age Group 1: Patients Aged 3 to 23 Months

Serious events: 8 serious events

Other events: 13 other events

Deaths: 0 deaths

Age Group 2: Patients Aged 28 Days to Less Than 3 Months

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Age Group 3: Patients Aged From Birth to 27 Days (Term Newborns)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Age Group 1: Patients Aged 3 to 23 Months n=33 participants at risk Patients aged 3-23 months who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).	Age Group 2: Patients Aged 28 Days to Less Than 3 Months n=2 participants at risk Patients aged 28-89 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).	Age Group 3: Patients Aged From Birth to 27 Days (Term Newborns) n=1 participants at risk Patients aged from birth to 27 days who underwent a contrast-enhanced MRI examination of any body region including central nervous system (CNS cohort) or vessels (Blood vessel cohort) or others region (Body cohort) with a single injection of gadopiclenol at a dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight).
Infections and infestations Gastroenteritis Norovirus	3.0% 1/33 • Number of events 1 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.	0.00% 0/2 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.	0.00% 0/1 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.
Infections and infestations Pneumonia Parainfluenzae Viral	3.0% 1/33 • Number of events 1 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.	0.00% 0/2 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.	0.00% 0/1 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.
Infections and infestations Bronchitis	3.0% 1/33 • Number of events 1 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.	0.00% 0/2 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.	0.00% 0/1 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.
Nervous system disorders Cerebral Cyst	3.0% 1/33 • Number of events 1 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.	0.00% 0/2 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.	0.00% 0/1 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.
Nervous system disorders Intracranial Pressure Increased	3.0% 1/33 • Number of events 1 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.	0.00% 0/2 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.	0.00% 0/1 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.
Product Issues Device Malfunction	3.0% 1/33 • Number of events 1 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.	0.00% 0/2 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.	0.00% 0/1 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.
Renal and urinary disorders Renal Failure	3.0% 1/33 • Number of events 1 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.	0.00% 0/2 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.	0.00% 0/1 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.
Metabolism and nutrition disorders Feeding Disorder	3.0% 1/33 • Number of events 1 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.	0.00% 0/2 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.	0.00% 0/1 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.
Surgical and medical procedures Tumour Excision	3.0% 1/33 • Number of events 1 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.	0.00% 0/2 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.	0.00% 0/1 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.
General disorders Pyrexia	3.0% 1/33 • Number of events 1 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.	0.00% 0/2 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.	0.00% 0/1 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.
Blood and lymphatic system disorders Microcytic Anaemia	3.0% 1/33 • Number of events 1 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.	0.00% 0/2 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.	0.00% 0/1 • 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). Safety set population (all patients who received one administration of gadopiclenol) was used for safety evaluation. Treatment emergent AEs (AEs occurring after gadopiclenol administration) were listed below.

Other adverse events

Additional Information

Frantz Hebert, Global Head of Clinical Development

Guerbet

Phone: +33 680249334

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place