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NCT05915728 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Any Known or Suspected Problems of the Body (Except Brain or Spinal Cord-related Problems)
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 404
- Enrollment target
NCT05915728 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 404 participants.
The verdict
NCT05915728, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 404 participants
- Enrollment target
Study Summary
Researchers are looking for a better way to help people with any known or suspected problems (except brain or spinal cord-related 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 contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation. The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI. The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect known or suspected problems (except brain or spinal cord-related problems) with gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent. The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein. Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits. At the start or during the study, the doctors and their study team will: * take blood and urine samples * do physical examinations * check blood pressure and heart rate * 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.
Interventions
- DRUG Gadobutrol
- DRUG Gadoteridol
- DRUG Gadoterate meglumine
- DRUG Gadoquatrane (BAY1747846)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 404 participants |
| Start Date | 2023-07-24 |
| Est. Completion | 2024-06-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05915728
The ClinicalTrials.gov registry entry for NCT05915728 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 404 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Gadobutrol is the first listed.
NCT05915728 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05915728 about?
NCT05915728 is a clinical study titled "A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Any Known or Suspected Problems of the Body (Except Brain or Spinal Cord-related Problems)". Researchers are looking for a better way to help people with any known or suspected problems (except brain or spinal cord-related 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 he...
What is the current status of trial NCT05915728?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 404 participants. The study started on 2023-07-24. Estimated completion is 2024-06-01.
What interventions are being tested in trial NCT05915728?
The interventions under investigation include: Gadobutrol (DRUG), Gadoteridol (DRUG), Gadoterate meglumine (DRUG), Gadoquatrane (BAY1747846) (DRUG).
Who is sponsoring clinical trial NCT05915728?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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