Contrast Enhancement in Magnetic Resonance ImagingPhase 3NCT05915026
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)
A Phase 3 study testing Gadoquatrane (BAY1747846) in people with Contrast Enhancement in Magnetic Resonance Imaging and Children, run by Bayer at 34 sites in 10 countries.
Trial summary
Researchers are looking for a better way to help children under the age of 18 with any known or suspected problems scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI). MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Contrast Enhancement in Magnetic Resonance Imaging, Children
- What is being tested?
- Gadoquatrane (BAY1747846)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 34 sitesin 10 countries
- Study dates
- 16 Aug 2023to 25 Sep 2024
- Phase
- Phase 3
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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants from birth to <18 years of age at the time of signing the informed consent form.
- Participants who have a clinical indication to undergo a CE-MRI for any clinical condition in any body region and who can undergo study procedures as per Investigator judgement.
- Participants can be male or female (according to their reproductive organs and functions assigned by chromosomal complement).
- Female contraception and barriers as well as pregnancy testing is required as appropriate for the age and sexual activity of pediatric participants and as required by local regulations.
- The legal guardian(s) is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- When applicable by law for a participant, a legal guardian must be available to help the study-site personnel ensure follow up, accompany the participant to the study site on each assessment day, and consistently and consecutively be available to provide information on the participant during the scheduled study visits.
Who cannot join
- Body weight <2500 g at screening and baseline
- The medical condition and/or local allowance for maximum blood draw in the pediatric participant is not suitable for study procedures, including pharmacokinetics (PK) and safety blood draws, without compromising any expected clinical care/procedure need.
- Acute kidney injury (i.e., acute renal failure).
- Age-adjusted renal function is "decreased" (eGFR <80% of age adjusted normal renal function) as evaluated by the investigator based on a serum or plasma creatinine result obtained within 2 weeks prior to study intervention.
- Considered clinically unstable or has a concurrent/concomitant condition that may not allow participation for the full planned study period, in the judgement of the investigator.
- History of moderate to severe allergic-like reaction to any GBCA.
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- Bronchial asthma considered unstable or had major therapeutical modification within last 4 weeks.
- Severe cardiovascular disease, except for cardiac or vascular magnetic resonance (MR), if considered clinically justified by the investigator.
- Planned or expected intervention (e.g., treatment or procedure) or change in treatment (e.g. start of chemotherapy) that may significantly affect study parameters (i.e. safety/adverse events [AEs] [e.g. confounding AEs or safety events due to surgery or chemotherapy], PK parameters) or would prevent the participant from performing study procedures, from the administration of gadoquatrane up to the 24 h ± 4 h follow-up.
- Participants who received or will receive any other contrast agent within 72 hours prior to gadoquatrane injection or up to 72 hours after gadoquatrane injection.
- Contraindications to the administration of GBCAs (depending on local product label), or history of adverse reaction to GBCAs.
Trial locations and contacts
34 sites in 10 countries.
34 sites in 10 countries
Japan10 sites
Juntendo University Hospital
Bunkyo, Tokyo, 113-8431
Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Children's Medical Center
Fuchū, Tokyo, 183-8561
Tokai University Hospital
Isehara, Kanagawa, 259-1193
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Nagoya, Aichi-ken, 453-8511
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, 460-0001
Nara Prefecture General Medical Center
Nara, Nara, 630-8581
National Center for Child Health and Development
Setagaya-ku, Tokyo, 157-8535
Jichi Medical University Hospital
Shimotsuke, Tochigi, 329-0498
Shizuoka Children's Hospital
Shizuoka, Shizuoka, 420-8660
Kanagawa Children's Medical Center
Yokohama, Kanagawa, 252-8555
Germany5 sites
Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Pädiatrische Radiologie
Berlin, 13353
Universitätsklinkum Halle (Saale) - Universitätsklinik und Poliklinik für Radiologie, Kinderradiologie
Halle, Saxony-Anhalt, 06120
Universitätsklinikum Jena - Institut für Diagnostische und Interventionelle Radiologie, Kinderradiologie
Jena, Thuringia, 07747
Universitätsklinikum Leipzig - Institut für Kinderradiologie
Leipzig, Saxony, 04103
Universitätsklinikum Münster - Klinik für Radiologie, Kinderradiologie
Münster, North Rhine-Westphalia, 48149
Bulgaria4 sites
University Multiprofile Hospital for Active Treatment Sveti Georgi | Base II - Radiology Department
Plovdiv, Plovdiv Province, 4000
Multiprofile Hospital for Active Treatment Central Onco Hospital | Independent Medical Diagnostic Laboratory Mediscan
Plovdiv, Plovdiv Province, 4002
University Multiprofile Hospital for Active Treatment St. Ivan Rilski | Radiology Department
Sofia, 1431
University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Radiology Department
Sofia, 1784
China4 sites
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, 100045
West China Second University Hospital
Chengdu, Sichuan, 610041
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
The Children's Hospital Zhejiang University School of Med
Hangzhou, Hangzhou Province, 310056
United States3 sites
MUSC University Hospital - Radiology
Charleston, South Carolina, 29425
Halo Diagnostics - Indian Wells
Indian Wells, California, 92210
Children's Mercy Hospital Kansas City - Radiology
Kansas City, Missouri, 64108
Argentina3 sites
Centro de Diagnostico Enrique Rossi | Departamento de Investigacion Clínica
Ciudad Autonoma de Buenos Aire, Ciudad Auton. de Buenos Aires, C1425BEE
Sanatorio Allende | Departamento de Investigación Clínica
Córdoba, Córdoba Province, X5000JHQ
Clinica Universitaria Reina Fabiola | Consultorios Externos
Córdoba, Córdoba Province, X5004FHP
Czechia2 sites
Fakultní nemocnice Ostrava
Ostrava - Poruba, 708 52
Fakultni nemocnice Plzen - Lochotin
Pilsen, 32300
Canada1 site
The Hospital for Sick Children (SickKids)
Toronto, Ontario, M5G 1X8
Sweden1 site
Karolinska Universitetssjukhuset Solna - Funktion Medicinsk Diagnostik, Barnradiologi
Stockholm, Stockholm County, 171 64
About this study
Official title: A Multicenter, Prospective, Open-label Study to Evaluate the Pharmacokinetics and Safety of Gadoquatrane in Pediatric Participants (From Birth to <18 Years) Undergoing Contrast-enhanced Magnetic Resonance Imaging (CE-MRI)
Researchers are looking for a better way to help children under the age of 18 with any known or suspected problems scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject a contrast agent into a patient's vein to perform a "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve their evaluation.
Read more
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd), which is needed for the increase in signal intensity and contrast in MRI. The gadolinium in these contrast agents is caged in a molecule (chelate complex). Researchers are developing new contrast agents with a lower amount of Gd needed per CE-MRI investigation. Gadoquatrane is one of these new contrast agents. It has been tested in several studies previously.
The main purpose of this study is to learn how gadoquatrane moves into, through, and out of the body and how safe it is in children. The researchers will measure the amount of gadoquatrane in the blood at different time points after a single injection.
The participants will undergo an MRI examination and receive gadoquatrane once at a dose of 0.04 mmol Gd/kg (corresponding to 0.1 mL/kg). It is injected into the participant's vein (also called an intravenous injection) during the MRI examination.
Each participant will be in the study for between 8 and 38 days with up to 5 doctor visits, including the screening phase of up to 28 days with no more than 2 visits. Once a participant has received the injection of gadoquatrane, the remaining study duration is 7 (±1) days.
At the start or during the study, the doctors and their study team will:
- check the weight and height of the participant,
- ask for information including age and medical history,
- take participants' blood samples,
- ask participants and/or their guardians questions about medicines they are taking,
- check blood pressure, heart rate and body temperature,
- check the area where the participants had the intravenous injection,
- do pregnancy tests in girls of childbearing age,
- review the MRI scans obtained in the study and decide on the diagnosis
- ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.
- Being tested
- Gadoquatrane (BAY1747846)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadoquatrane (BAY1747846)Drug
0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose
| Study group | Role | What they receive |
|---|---|---|
| Gadoquatrane | Experimental | Participants will receive one intravenous injection of gadoquatrane during MRI. Receives: Drug: Gadoquatrane (BAY1747846) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) of Gadoquatrane After Single Administration
Median values (5th and 95th percentile)
Measured: Up to 8 hours post injection
Plasma Clearance Normalized to Body Weight (CL/BW) of Gadoquatrane After Single Administration
Median values (5th and 95th percentile)
Measured: Up to 8 hours post injection
Apparent Volume of Distribution at Steady State Normalized to Body Weight (Vss/BW) of Gadoquatrane After Single Administration
Median values (5th and 95th percentile)
Measured: Up to 8 hours post injection
Simulation of Plasma Concentration at 10, 20 and 30 Minutes Post-injection (C10, C20 and C30)
Median values (5th and 95th percentile)
Measured: At 10, 20 and 30 minutes post injection
Secondary outcomes (4)
Number of Participants With Treatment Emergent Adverse Events, Including Serious Adverse Events
Number 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.
Measured: Within 24 (± 4) hours post injection
Number of Participants With Treatment Emergent Adverse Events Per Intensity
Number 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.
Measured: Within 24 (± 4) hours post injection
Number of Participants With Post-treatment Adverse Events, Including Serious Adverse Events
Number 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.
Measured: Between 24 (± 4) hours and 7 (± 1) days after the day of study intervention
Number of Participants With Post-treatment Adverse Events Per Intensity
Number 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.
Measured: Between 24 (± 4) hours to 7 (± 1) days after the day of study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start16 Aug 2023
- Primary completion18 Sep 2024
- Study completion25 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 Contrast Enhancement in Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915026
- Sponsor's protocol ID
- 21196
- Other IDs
- 2022-501883-17-00
- Status last verified
- Jul 2026
- First submitted
- 14 Jun 2023
- Last updated
- 17 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.