Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects for CNS Imaging

Magnetic Resonance Imaging Clinical Trial

Official title:

A Multicenter, Open-label, Phase III Study to Determine the Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects Referred for Contrast-enhanced MRI of the Central Nervous System (CNS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660841
• Other study ID #: 16260
• Status: Completed
• Phase: Phase 3
• First received: August 7, 2012
• Last updated: September 30, 2014
• Start date: September 2012
• Est. completion date: August 2013

Study information

• Verified date: September 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

Purpose of the study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking images of the brain and spine. The results of the Magnetic Resonance Imaging (MRI) will be compared to the results of images taken without contrast (gadobutrol).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects referred for a contrast-enhanced Magnetic Resonance Imaging (MRI) of the central nervous system based on current clinical symptoms or results of a previous imaging procedure

Exclusion Criteria:

• Subjects with any contraindication to the MRI examination

• Subjects with severe renal disease to end stage renal disease

• Subjects scheduled or are likely to require a biopsy or any interventional therapeutic procedure within 72 (±4) hours after the study MRI

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Magnetic Resonance Imaging

Intervention

Drug:
• Gadobutrol (Gadovist, BAY86-4875)
A single bolus injection of gadobutrol 1.0M 0.1mmol/kg body weight.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores for visualization parameter: degree of contrast enhancement	Blinded readers evaluate contrast of at maximum 5 lesions and 4 normal brain structures in scans taken with and without injection of gadobutrol on a 4-point-scale.	Day of gadobutrol injection (Day 0)	No
Primary	Scores for visualization parameter: border delineation	Blinded readers evaluate border delineation of at maximum 5 lesions and 4 normal brain structures in scans taken with and without injection of gadobutrol on a 4-point-scale.	Day of gadobutrol injection (Day 0)	No
Primary	Scores for visualization parameter: internal morphology	Blinded readers evaluate internal morphology of at maximum 5 lesions and 4 normal structures in scans taken with and without gadobutrol on a 3-point-scale.	Day of gadobutrol injection (Day 0)	No
Primary	Number of detected lesions	Blinded readers determine number of detected lesions in scans with and without gadobutrol.	Day of gadobutrol injection (Day 0)	No
Secondary	Percentage of exact match of the MRI diagnosis with the final clinical diagnosis	An exact match is defined as identical diagnosis given by the blinded reader and the independent standard of truth committee.	Day of gadobutrol injection (Day 0)	No
Secondary	Sensitivity and specificity to detect abnormal/normal brain tissue	Blinded readers classify the brain tissue as normal or abnormal based on the MRI sets.	Day of gadobutrol injection (Day 0)	No
Secondary	Sensitivity and specificity to detect malignant Central Nervous System(CNS) lesions	Percentage to correctly detect presence and absence of malignant lesions which are derived from the MR diagnosis of readers when compared with the diagnosis of the independent standard of truth committee.	Day of gadobutrol injection (Day 0)	No
Secondary	Number of participants with treatment emergent adverse events as a measure of safety and tolerability		3 days after injection (Day 3)	Yes

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