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New MRI dye could make scans safer for kids

NCT ID NCT05915026

Diagnosis Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study tests a new contrast agent called gadoquatrane in children from birth to under 18 years old who need a contrast-enhanced MRI. The goal is to see how the drug moves through the body and check its safety. Each child gets a single injection during their MRI, and researchers take blood samples and monitor for side effects over about a week.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
gadoquatrane, a new gadolinium-based contrast agent for MRI
What this could lead to
If successful, this could lead to safer MRI scans for children using a lower dose of gadolinium.
What could go wrong
This is a Phase 3 study focused on safety and drug levels, not on how well the contrast works. It may not prove better images or fewer side effects than existing agents.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

105 people

The number who actually took part.

Started

Aug 2023

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Children Contrast enhancement in magnetic resonance imaging

Contacts and locations

Locations

  • Beijing Children's Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100045, China

  • Centro de Diagnostico Enrique Rossi | Departamento de Investigacion Clínica

    Ciudad Autonoma de Buenos Aire, Ciudad Auton. de Buenos Aires, C1425BEE, Argentina

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

    Berlin, 13353, Germany

  • Children's Mercy Hospital Kansas City - Radiology

    Kansas City, Missouri, 64108, United States

  • Clinica Universitaria Reina Fabiola | Consultorios Externos

    Córdoba, Córdoba Province, X5004FHP, Argentina

  • Fakultni nemocnice Plzen - Lochotin

    Pilsen, 32300, Czechia

  • Fakultní nemocnice Ostrava

    Ostrava - Poruba, 708 52, Czechia

  • Halo Diagnostics - Indian Wells

    Indian Wells, California, 92210, United States

  • Instytut "Pomnik - Centrum Zdrowia Dziecka"

    Warsaw, 04-730, Poland

  • Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital

    Nagoya, Aichi-ken, 453-8511, Japan

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi, 329-0498, Japan

  • Juntendo University Hospital

    Bunkyo, Tokyo, 113-8431, Japan

  • Kanagawa Children's Medical Center

    Yokohama, Kanagawa, 252-8555, Japan

  • Karolinska Universitetssjukhuset Solna - Funktion Medicinsk Diagnostik, Barnradiologi

    Stockholm, Stockholm County, 171 64, Sweden

  • MUSC University Hospital - Radiology

    Charleston, South Carolina, 29425, United States

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

    Plovdiv, Plovdiv Province, 4002, Bulgaria

  • Nara Prefecture General Medical Center

    Nara, Nara, 630-8581, Japan

  • National Center for Child Health and Development

    Setagaya-ku, Tokyo, 157-8535, Japan

  • National Hospital Organization Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001, Japan

  • Sanatorio Allende | Departamento de Investigación Clínica

    Córdoba, Córdoba Province, X5000JHQ, Argentina

  • Shizuoka Children's Hospital

    Shizuoka, Shizuoka, 420-8660, Japan

  • The Children's Hospital Zhejiang University School of Med

    Hangzhou, Hangzhou Province, 310056, China

  • The Hospital for Sick Children (SickKids)

    Toronto, Ontario, M5G 1X8, Canada

  • Tokai University Hospital

    Isehara, Kanagawa, 259-1193, Japan

  • Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Children's Medical Center

    Fuchū, Tokyo, 183-8561, Japan

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

    Sofia, 1784, Bulgaria

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

    Sofia, 1431, Bulgaria

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

    Plovdiv, Plovdiv Province, 4000, Bulgaria

  • Universitätsklinikum Jena - Institut für Diagnostische und Interventionelle Radiologie, Kinderradiologie

    Jena, Thuringia, 07747, Germany

  • Universitätsklinikum Leipzig - Institut für Kinderradiologie

    Leipzig, Saxony, 04103, Germany

  • Universitätsklinikum Münster - Klinik für Radiologie, Kinderradiologie

    Münster, North Rhine-Westphalia, 48149, Germany

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

    Halle, Saxony-Anhalt, 06120, Germany

  • West China Second University Hospital

    Chengdu, Sichuan, 610041, China

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280, China

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