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Contrast Agent

Gadobutrol (Gadavist, BAY86-4875) for Central Nervous System Disorder

Phase 3

Waitlist Available

Research Sponsored by Bayer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Patients referred for contrast enhanced MRI of the CNS based on symptoms or previous procedures.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 hours after injection of gadobutrol

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Summary

This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Gadavist. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Gadavist.

Eligible Conditions

Central Nervous System Disorder
Central Nervous System Disorders

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 hours after injection of gadobutrol

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 hours after injection of gadobutrol

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 hours after injection of gadobutrol for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Magnetic Resonance Imaging

Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Average Reader (AR)

+2 more

Secondary study objectives

Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator

Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader

Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images

+23 more

Side effects data

From 2007 Phase 3 trial • 147 Patients • NCT00395460

Hyponatraemia

Erythema

Insomnia

Feeling abnormal

100%

80%

60%

40%

20%

Study treatment Arm

GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)

Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Gadobutrol (Gadavist, BAY86-4875)Experimental Treatment1 Intervention

Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gadobutrol

FDA approved

0 / 1Eligibility criteria met