Trials / Completed
CompletedNCT04307186
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
Multicenter, Single-blind, Adaptive Dose Finding Study of Single Intravenous Injections of BAY 1747846 With Corresponding Blinded Read in Adult Participants With Known or Highly Suspected CNS Lesions Referred for Contrast-enhanced MRI of the CNS
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 57 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gadoquatrane (BAY1747846) | Solution for IV injection, single dose |
| DRUG | Gadobutrol (Gadovist/Gadavist) | Solution for IV injection, single dose |
Timeline
- Start date
- 2020-11-18
- Primary completion
- 2022-09-05
- Completion
- 2022-09-06
- First posted
- 2020-03-13
- Last updated
- 2023-11-15
- Results posted
- 2023-11-15
Locations
17 sites across 4 countries: United States, Bulgaria, Germany, Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04307186. Inclusion in this directory is not an endorsement.