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NCT04307186 · ClinicalTrials.gov registry record · Phase 2
Study to Find the Appropriate Dose of a New Gadolinium-based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Brain and/or Spinal Cord Conditions
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
NCT04307186: Completed Phase 2 study, sponsored by Bayer.
NCT04307186 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 57 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04307186, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
Study Summary
Researchers in this study want to find the appropriate dose of drug BAY1747846 for adults undergoing MRI for known or highly suspected brain and/or spinal cord conditions so that the image quality is similar to that of drug gadobutrol for adults undergoing MRI. MRI stands for Magnetic resonance imaging which produces body pictures created by using magnetic energy rather than x-ray energy. Both BAY1747846 and gadobutrol are medicinal products known as gadolinium-based contrast agents (GBCA) which are used in MRI examinations to provide contrast enhancement and improve imaging performance. Gadobutrol (brand name: Gadavist, Gadovist) has been approved worldwide for the diagnosis of various disorders in adult and pediatric patients. BAY1747846 is a new GBCA under development with the goal to provide similar imaging performances in MRI. Participants in this study will receive both BAY1747846 and gadobutrol with a period of 3 - 14 days in between. A MRI examination will be performed after each injection. Participant will stay in this study for 2 - 4 weeks depending on the scheduling of the visits.
Primary Outcome
Overall diagnostic preference using a matched pairs approach was evaluated by 3 blinded readers using an ordinal 5-point scale (greatly prefer gadoquatrane, prefer gadoquatrane, no preference, prefer gadobutrol, greatly prefer gadobutrol). Percentage of participants and the respective Wald confidence intervals (CI) for image preference were reported for each of the 3 readers based on the 3-point preference scale (1=greatly prefer/prefer gadoquatrane, 0=no preference, -1=greatly prefer/prefer gad
Interventions
- DRUG Gadoquatrane (BAY1747846)
- DRUG Gadobutrol (Gadovist/Gadavist)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2020-11-18 |
| Est. Completion | 2022-09-06 |
| Phase | Phase 2 |
What the finished NCT04307186 record still lists
NCT04307186 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Gadoquatrane (BAY1747846) is the first listed.
NCT04307186 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04307186 about?
NCT04307186 is a clinical study titled "Study to Find the Appropriate Dose of a New Gadolinium-based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Brain and/or Spinal Cord Conditions". Researchers in this study want to find the appropriate dose of drug BAY1747846 for adults undergoing MRI for known or highly suspected brain and/or spinal cord conditions so that the image quality is similar to that of drug gadobutrol for adults undergoing MRI. MRI stands for Magnetic resonance imag...
What is the current status of trial NCT04307186?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2020-11-18. Estimated completion is 2022-09-06.
What interventions are being tested in trial NCT04307186?
The interventions under investigation include: Gadoquatrane (BAY1747846) (DRUG), Gadobutrol (Gadovist/Gadavist) (DRUG).
Who is sponsoring clinical trial NCT04307186?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04307186's enrollment target sits among peer trials
57 1141st of 2000 higher than 855 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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