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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 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.
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
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2023-08-16 |
| Est. Completion | 2024-10-16 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05915026
The ClinicalTrials.gov registry entry for NCT05915026 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 357,290-participant average among 14 other Children trials with a reported enrollment target (100% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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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