Trial Condition(s):

Magnetic Resonance Imaging

Safety and efficacy of gadobutrol 1.0 molar in Japanese subjects for CNS imaging

Bayer Identifier:

16260

ClinicalTrials.gov Identifier:

NCT01660841

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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).

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

Trial Summary

Enrollment Goal
223
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Chiba Tokushukai Hospital

Funabashi, Japan, 274-8503

Status
Completed
 
Locations

Kawasaki Municipal Hospital

Kawasaki, Japan, 210-0013

Status
Completed
 
Locations

Yokohama Shinmidori General Hospital

Yokohama, Japan, 226-0025

Status
Completed
 
Locations

Fujisawa City Hospital

Fujisawa, Japan, 251-8550

Status
Completed
 
Locations

Chubu Rosai Hospital

Nagoya, Japan, 455-8530

Status
Completed
 
Locations

Nozaki Tokushukai Hospital

Daito, Japan, 574-0074

Status
Completed
 
Locations

Kishiwada Tokushukai Hospital

Kishiwada, Japan, 596-8522

Status
Completed
 
Locations

Institute of Biomedical Research and Innovation

Kobe, Japan, 650-0047

Status
Completed
 
Locations

Shinsuma Hospital

Kobe, Japan, 654-0047

Status
Completed
 
Locations

Ube Industries Central Hospital

Ube, Japan, 755-0151

Status
Completed
 
Locations

Shimonoseki Kosei Hospital

Shimonoseki, Japan, 750-0061

Status
Completed
 
Locations

Fukuokaken Saiseikai Fukuoka General Hospital

Fukuoka, Japan, 810-0001

Status
Completed
 
Locations

Shinkomonji Hospital

Kitakyushu, Japan, 800-0057

Status
Completed
 
Locations

Fukuoka Wajiro Hospital

Fukuoka, Japan, 811-0213

Status
Completed
 
Locations

Brain Attack Center Oota Memorial Hospital

Fukuyama, Japan, 720-0825

Status
Completed
 

Trial Design