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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01660841
Other study ID # 16260
Secondary ID
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


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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