Trial Outcomes & Findings for A Study to Learn How Gadoquatrane Moves Into, Through, and Out of the Body and How Safe it is in Children (From Birth to <18 Years), Who Will Undergo a Contrast Enhanced MRI (Quanti Pediatric) (NCT NCT05915026)
NCT ID: NCT05915026
Last Updated: 2026-07-17
Results Overview
Median values (5th and 95th percentile)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
105 participants
Primary outcome timeframe
Up to 8 hours post injection
Results posted on
2026-07-17
Participant Flow
A total of 105 participants signed the ICF. 8 participants were screen failures, 3 withdrew their consent and 1 participant could not continue due to internal site issues. Of the 105 participants, 93 received the study drug. 92 completed the overall study. 1 participant did not finish the FUP visit. The study was conducted in 29 sites in 10 countries from 16 August 2023 (First Patient First Visit) to 25 September 2024 (Last Patient Last Visit).
Participant milestones
| Measure |
Gadoquatrane
Participants received gadoquatrane by intravenous injection at a dose of 0.04 mmol Gd/kg bw.
|
|---|---|
|
Overall Study
STARTED
|
93
|
|
Overall Study
COMPLETED
|
92
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Gadoquatrane
Participants received gadoquatrane by intravenous injection at a dose of 0.04 mmol Gd/kg bw.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
A Study to Learn How Gadoquatrane Moves Into, Through, and Out of the Body and How Safe it is in Children (From Birth to <18 Years), Who Will Undergo a Contrast Enhanced MRI (Quanti Pediatric)
Baseline characteristics by cohort
| Measure |
Gadoquatrane
n=93 Participants
Participants received gadoquatrane by intravenous injection at a dose of 0.04 mmol Gd/kg bw.
|
|---|---|
|
Age, Continuous
Total
|
7.13 Years
STANDARD_DEVIATION 5.48 • n=20 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
35 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=20 Participants
|
|
Body Weight (Bw)
|
29.98 Kg
STANDARD_DEVIATION 23.65 • n=20 Participants
|
PRIMARY outcome
Timeframe: Up to 8 hours post injectionPopulation: One participant (1.1%) was excluded due to a saline flush having not been conducted, which is important to ensure injection of the entire gadoquatrane dose
Median values (5th and 95th percentile)
Outcome measures
| Measure |
Gadoquatrane
n=92 Participants
Participants received gadoquatrane by intravenous injection at a dose of 0.04 mmol Gd/kg bw.
|
|---|---|
|
Area Under the Curve (AUC) of Gadoquatrane After Single Administration
0 to < 2 years
|
287 (µmol Gd*h)/L
Interval 214.0 to 353.0
|
|
Area Under the Curve (AUC) of Gadoquatrane After Single Administration
2 to < 12 years
|
250 (µmol Gd*h)/L
Interval 200.0 to 342.0
|
|
Area Under the Curve (AUC) of Gadoquatrane After Single Administration
12 to < 18 years
|
347 (µmol Gd*h)/L
Interval 264.0 to 460.0
|
PRIMARY outcome
Timeframe: Up to 8 hours post injectionPopulation: One participant (1.1%) was excluded due to a saline flush having not been conducted, which is important to ensure injection of the entire gadoquatrane dose
Median values (5th and 95th percentile)
Outcome measures
| Measure |
Gadoquatrane
n=92 Participants
Participants received gadoquatrane by intravenous injection at a dose of 0.04 mmol Gd/kg bw.
|
|---|---|
|
Plasma Clearance Normalized to Body Weight (CL/BW) of Gadoquatrane After Single Administration
0 to < 2 years
|
0.139 L/(h*kg)
Interval 0.113 to 0.19
|
|
Plasma Clearance Normalized to Body Weight (CL/BW) of Gadoquatrane After Single Administration
2 to < 12 years
|
0.160 L/(h*kg)
Interval 0.116 to 0.202
|
|
Plasma Clearance Normalized to Body Weight (CL/BW) of Gadoquatrane After Single Administration
12 to < 18 years
|
0.115 L/(h*kg)
Interval 0.0869 to 0.15
|
PRIMARY outcome
Timeframe: Up to 8 hours post injectionPopulation: One participant (1.1%) was excluded due to a saline flush having not been conducted, which is important to ensure injection of the entire gadoquatrane dose
Median values (5th and 95th percentile)
Outcome measures
| Measure |
Gadoquatrane
n=92 Participants
Participants received gadoquatrane by intravenous injection at a dose of 0.04 mmol Gd/kg bw.
|
|---|---|
|
Apparent Volume of Distribution at Steady State Normalized to Body Weight (Vss/BW) of Gadoquatrane After Single Administration
0 to < 2 years
|
0.245 L/kg
Interval 0.226 to 0.259
|
|
Apparent Volume of Distribution at Steady State Normalized to Body Weight (Vss/BW) of Gadoquatrane After Single Administration
2 to < 12 years
|
0.233 L/kg
Interval 0.199 to 0.244
|
|
Apparent Volume of Distribution at Steady State Normalized to Body Weight (Vss/BW) of Gadoquatrane After Single Administration
12 to < 18 years
|
0.198 L/kg
Interval 0.171 to 0.23
|
PRIMARY outcome
Timeframe: At 10, 20 and 30 minutes post injectionPopulation: One participant (1.1%) was excluded due to a saline flush having not been conducted, which is important to ensure injection of the entire gadoquatrane dose
Median values (5th and 95th percentile)
Outcome measures
| Measure |
Gadoquatrane
n=92 Participants
Participants received gadoquatrane by intravenous injection at a dose of 0.04 mmol Gd/kg bw.
|
|---|---|
|
Simulation of Plasma Concentration at 10, 20 and 30 Minutes Post-injection (C10, C20 and C30)
0 to < 2 years 20 min after drug injection (C20)
|
153 µmol/L
Interval 135.0 to 164.0
|
|
Simulation of Plasma Concentration at 10, 20 and 30 Minutes Post-injection (C10, C20 and C30)
0 to < 2 years 30 min after drug injection (C30)
|
127 µmol/L
Interval 111.0 to 140.0
|
|
Simulation of Plasma Concentration at 10, 20 and 30 Minutes Post-injection (C10, C20 and C30)
2 to < 12 years 10 min after drug injection (C10)
|
190 µmol/L
Interval 175.0 to 228.0
|
|
Simulation of Plasma Concentration at 10, 20 and 30 Minutes Post-injection (C10, C20 and C30)
2 to < 12 years 20 min after drug injection (C20)
|
156 µmol/L
Interval 139.0 to 193.0
|
|
Simulation of Plasma Concentration at 10, 20 and 30 Minutes Post-injection (C10, C20 and C30)
2 to < 12 years 30 min after drug injection (C30)
|
128 µmol/L
Interval 109.0 to 163.0
|
|
Simulation of Plasma Concentration at 10, 20 and 30 Minutes Post-injection (C10, C20 and C30)
12 to < 18 years 10 min after drug injection (C10)
|
236 µmol/L
Interval 193.0 to 268.0
|
|
Simulation of Plasma Concentration at 10, 20 and 30 Minutes Post-injection (C10, C20 and C30)
12 to < 18 years 20 min after drug injection (C20)
|
200 µmol/L
Interval 161.0 to 228.0
|
|
Simulation of Plasma Concentration at 10, 20 and 30 Minutes Post-injection (C10, C20 and C30)
12 to < 18 years 30 min after drug injection (C30)
|
169 µmol/L
Interval 134.0 to 195.0
|
|
Simulation of Plasma Concentration at 10, 20 and 30 Minutes Post-injection (C10, C20 and C30)
0 to < 2 years 10 min after drug injection (C10)
|
184 µmol/L
Interval 167.0 to 199.0
|
SECONDARY outcome
Timeframe: Within 24 (± 4) hours post injectionNumber of participants with treatment emergent adverse events (TEAEs) including serious adverse events (SAEs). An AE is considered treatment-emergent, if it started or worsened within 24 (±4) hours post-injection of gadoquatrane.
Outcome measures
| Measure |
Gadoquatrane
n=93 Participants
Participants received gadoquatrane by intravenous injection at a dose of 0.04 mmol Gd/kg bw.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events, Including Serious Adverse Events
Number of participants with any TEAEs
|
16 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events, Including Serious Adverse Events
Number of participants with any TESAEs
|
3 Participants
|
SECONDARY outcome
Timeframe: Within 24 (± 4) hours post injectionNumber of participants with TEAEs per severity. An AE is considered treatment-emergent, if it started or worsened within 24 (±4) hours post-injection of gadoquatrane.
Outcome measures
| Measure |
Gadoquatrane
n=93 Participants
Participants received gadoquatrane by intravenous injection at a dose of 0.04 mmol Gd/kg bw.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events Per Intensity
Number of participants with any mild intensity TEAE
|
11 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events Per Intensity
Number of participants with any moderate intensity TEAE
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events Per Intensity
Number of participants with any severe intensity TEAE
|
1 Participants
|
SECONDARY outcome
Timeframe: Between 24 (± 4) hours and 7 (± 1) days after the day of study interventionNumber of participants with post-treatment adverse events (PTAEs). An AE is considered a PTAE if it started or worsened between the 24 ± 4 hours after gadoquatrane administration and the follow-up period of 7 ± 1 day post-injection.
Outcome measures
| Measure |
Gadoquatrane
n=93 Participants
Participants received gadoquatrane by intravenous injection at a dose of 0.04 mmol Gd/kg bw.
|
|---|---|
|
Number of Participants With Post-treatment Adverse Events, Including Serious Adverse Events
Number of participants with any PTAEs
|
11 Participants
|
|
Number of Participants With Post-treatment Adverse Events, Including Serious Adverse Events
Number of participants with any serious PTAEs
|
0 Participants
|
SECONDARY outcome
Timeframe: Between 24 (± 4) hours to 7 (± 1) days after the day of study interventionNumber of participants with PTAEs. An AE is considered a PTAE if it started or worsened between the 24 ± 4 hours after gadoquatrane administration and the follow-up period of 7 ± 1 day post-injection.
Outcome measures
| Measure |
Gadoquatrane
n=93 Participants
Participants received gadoquatrane by intravenous injection at a dose of 0.04 mmol Gd/kg bw.
|
|---|---|
|
Number of Participants With Post-treatment Adverse Events Per Intensity
Number of participants with any mild intensity PTAE
|
8 Participants
|
|
Number of Participants With Post-treatment Adverse Events Per Intensity
Number of participants with any moderate intensity PTAE
|
3 Participants
|
|
Number of Participants With Post-treatment Adverse Events Per Intensity
Number of participants with any severe intensity PTAE
|
0 Participants
|
Adverse Events
Gadoquatrane (BAY 1747846)
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gadoquatrane (BAY 1747846)
n=93 participants at risk
Participants received an intravenous injection of 0.01 mmol/kg body weight corresponding to 0.04 mmol Gd/kg body weight.
|
|---|---|
|
General disorders and administration site conditions
Pyrexia
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Immune system disorders
Hypersensitivity
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Nervous system disorders
Hydrocephalus
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
Other adverse events
| Measure |
Gadoquatrane (BAY 1747846)
n=93 participants at risk
Participants received an intravenous injection of 0.01 mmol/kg body weight corresponding to 0.04 mmol Gd/kg body weight.
|
|---|---|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Metabolism and nutrition disorders
Tetany
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Congenital, familial and genetic disorders
Spina bifida occulta
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Eye disorders
Strabismus
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Eye disorders
Swelling of eyelid
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Gastrointestinal disorders
Stomatitis
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
General disorders and administration site conditions
Injection site haematoma
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
General disorders and administration site conditions
Pyrexia
|
2.2%
2/93 • Number of events 2 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
General disorders and administration site conditions
Infusion site pain
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Hepatobiliary disorders
Hepatic lesion
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Injury, poisoning and procedural complications
Contusion
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Investigations
Intraocular pressure increased
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Investigations
Platelet count decreased
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Investigations
Hepatic enzyme increased
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Nervous system disorders
Dizziness
|
2.2%
2/93 • Number of events 3 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
|
Vascular disorders
Hypertension
|
1.1%
1/93 • Number of events 1 • After administering the study intervention up to post-treatment period of 7 (±1) days after the day of study intervention.
All AEs
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The results of this study may be published or presented at scientific meetings. If this is foreseen, the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission.
- Publication restrictions are in place
Restriction type: OTHER