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Gadolinium-based Contrast Agent

Gadobutrol + Gadoquatrane for Central Nervous System Disease

Phase 2
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 5 minute post each injection
Awards & highlights

Study Summary

This trial is researching the appropriate dose of a new 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 the current standard of care drug, gadobutrol.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 5 minute post each injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 5 minute post each injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Diagnostic Preference
Secondary outcome measures
Lesion Visualization Parameter Border Delineation on Pre-contrast and Combined Pre- and Post-contrast Images
Lesion Visualization Parameter Contrast Enhancement on Pre-contrast and Combined Pre- and Post-contrast Images
Lesion Visualization Parameter Internal Morphology on Pre-contrast and Combined Pre- and Post-contrast Images
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Gadobutrol + GadoquatraneExperimental Treatment2 Interventions
Participants will receive one intravenous (IV) injection of gadobutrol 0.1 millimole(s) gadolinium/kilogram body weight (mmol Gd/kg bw) and one IV injection of Gadoquatrane (BAY1747846).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gadobutrol (Gadovist/Gadavist)
2020
Completed Phase 2
~60
Gadoquatrane (BAY1747846)
2020
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,238 Previous Clinical Trials
25,332,661 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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
2020. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04307186.
~13 spots leftby Apr 2025
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