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 ID: NCT05915026

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-16
• Study Completion Date: 2024-10-16

Brief 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. 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.

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.

Conditions

Contrast Enhancement in Magnetic Resonance Imaging; Children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Gadoquatrane

Participants will receive one intravenous injection of gadoquatrane during MRI.

Group Type: EXPERIMENTAL

Gadoquatrane (BAY1747846)

Intervention Type: DRUG

0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose

Interventions

Gadoquatrane (BAY1747846)

0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Halo Diagnostics - Indian Wells

Indian Wells, California, United States

Children's Mercy Hospital Kansas City - Radiology

Kansas City, Missouri, United States

MUSC University Hospital - Radiology

Charleston, South Carolina, United States

Centro de Diagnostico Enrique Rossi | Departamento de Investigacion Clínica

Ciudad Autonoma de Buenos Aire, Ciudad Auton. de Buenos Aires, Argentina

Sanatorio Allende | Departamento de Investigación Clínica

Córdoba, , Argentina

Clinica Universitaria Reina Fabiola | Consultorios Externos

Córdoba, , Argentina

University Multiprofile Hospital for Active Treatment Sveti Georgi | Base II - Radiology Department

Plovdiv, , Bulgaria

Multiprofile Hospital for Active Treatment Central Onco Hospital | Independent Medical Diagnostic Laboratory Mediscan

Plovdiv, , Bulgaria

University Multiprofile Hospital for Active Treatment St. Ivan Rilski | Radiology Department

Sofia, , Bulgaria

University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Radiology Department

Sofia, , Bulgaria

The Hospital for Sick Children (SickKids)

Toronto, Ontario, Canada

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

The Children's Hospital Zhejiang University School of Med

Hangzhou, Hangzhou Province, China

West China Second University Hospital

Chengdu, Sichuan, China

Fakultní nemocnice Ostrava

Ostrava - Poruba, , Czechia

Fakultni nemocnice Plzen - Lochotin

Pilsen, , Czechia

Universitätsklinikum Münster - Klinik für Radiologie, Kinderradiologie

Münster, North Rhine-Westphalia, Germany

Universitätsklinikum Leipzig - Institut für Kinderradiologie

Leipzig, Saxony, Germany

Universitätsklinkum Halle (Saale) - Universitätsklinik und Poliklinik für Radiologie, Kinderradiologie

Halle, Saxony-Anhalt, Germany

Universitätsklinikum Jena - Institut für Diagnostische und Interventionelle Radiologie, Kinderradiologie

Jena, Thuringia, Germany

Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Pädiatrische Radiologie

Berlin, , Germany

Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital

Nagoya, Aichi-ken, Japan

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Tokai University Hospital

Isehara, Kanagawa, Japan

Kanagawa Children's Medical Center

Yokohama, Kanagawa, Japan

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

Juntendo University Hospital

Bunkyo, Tokyo, Japan

Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Children's Medical Center

Fuchū, Tokyo, Japan

National Center for Child Health and Development

Setagaya-ku, Tokyo, Japan

Nara Prefecture General Medical Center

Nara, , Japan

Shizuoka Children's Hospital

Shizuoka, , Japan

Instytut "Pomnik - Centrum Zdrowia Dziecka"

Warsaw, , Poland

Karolinska Universitetssjukhuset Solna - Funktion Medicinsk Diagnostik, Barnradiologi

Stockholm, , Sweden

Countries

United States; Argentina; Bulgaria; Canada; China; Czechia; Germany; Japan; Poland; Sweden

Related Links

https://clinicaltrials.bayer.com/

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Other Identifiers

2022-501883-17-00

Identifier Type: OTHER

Identifier Source: secondary_id

21196

Identifier Type: -

Identifier Source: org_study_id