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NCT05915026 · ClinicalTrials.gov registry record · Phase 3

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 of Children and Contrast Enhancement in Magnetic Resonance Imaging, sponsored by Bayer.

Completed
Registry status
Phase 3
Development phase
93
Enrollment target
20
Study locations

NCT05915026: Completed Phase 3 study of Children and Contrast Enhancement in Magnetic Resonance Imaging, sponsored by Bayer.

NCT05915026 is a Phase 3 study of Children and Contrast Enhancement in Magnetic Resonance Imaging that has completed, run by Bayer. The registered enrollment target is 93 participants, below the 357,290-participant average among 14 other Children trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05915026, a Phase 3 study of Children and Contrast Enhancement in Magnetic Resonance Imaging, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 3
Development phase
93 participants
Enrollment target
20
Study locations

Study 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 pa

Primary Outcome

Median values (5th and 95th percentile)

Conditions Studied

Children Contrast Enhancement in Magnetic Resonance Imaging

Interventions

  • DRUG Gadoquatrane (BAY1747846)

Study Locations (20)

Other

  • Sanatorio Allende | Departamento de Investigación Clínica - Córdoba
  • Clinica Universitaria Reina Fabiola | Consultorios Externos - Córdoba
  • University Multiprofile Hospital for Active Treatment Sveti Georgi | Base II - Radiology Department - Plovdiv
  • Multiprofile Hospital for Active Treatment Central Onco Hospital | Independent Medical Diagnostic Laboratory Mediscan - Plovdiv
  • University Multiprofile Hospital for Active Treatment St. Ivan Rilski | Radiology Department - Sofia
  • University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Radiology Department - Sofia
  • Fakultní nemocnice Ostrava - Ostrava - Poruba
  • Fakultni nemocnice Plzen - Lochotin - Pilsen

California

  • Halo Diagnostics - Indian Wells - Indian Wells

Missouri

  • Children's Mercy Hospital Kansas City - Radiology - Kansas City

South Carolina

  • MUSC University Hospital - Radiology - Charleston

Ciudad Auton. de Buenos Aires

  • Centro de Diagnostico Enrique Rossi | Departamento de Investigacion Clínica - Ciudad Autonoma de Buenos Aire

Ontario

  • The Hospital for Sick Children (SickKids) - Toronto

Beijing Municipality

  • Beijing Children's Hospital, Capital Medical University - Beijing

Guangdong

  • Zhujiang Hospital of Southern Medical University - Guangzhou

Trial Details

FieldValue
Enrollment Target 93 participants
Start Date 2023-08-16
Est. Completion 2024-10-16
Phase Phase 3
Bayer

591 total trials

What the finished NCT05915026 record still lists

NCT05915026 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 357,290-participant average among 14 other Children trials with a reported enrollment target (100% lower).

The record links to 2 conditions, with Children appearing as the primary indexed condition, and to 1 intervention - of which Gadoquatrane (BAY1747846) is the first listed.

NCT05915026 names 20 study sites across 13 states, led by Other, California, Missouri.

Frequently Asked Questions

What is clinical trial NCT05915026 about?

NCT05915026 is a clinical study titled "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)". 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 ...

What is the current status of trial NCT05915026?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 93 participants. The study started on 2023-08-16. Estimated completion is 2024-10-16.

What conditions does trial NCT05915026 study?

This clinical trial studies the following conditions: Children, Contrast Enhancement in Magnetic Resonance Imaging.

What interventions are being tested in trial NCT05915026?

The interventions under investigation include: Gadoquatrane (BAY1747846) (DRUG).

Who is sponsoring clinical trial NCT05915026?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05915026 being conducted?

This trial has 20 study locations across California, Missouri, South Carolina, Ciudad Auton. de Buenos Aires, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05915026's enrollment target sits among peer trials

93 8th of 14 higher than 7 of 14 other Children trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Children trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05915026, the US trial registry maintained by the National Library of Medicine. NCT05915026 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.