Clinical trial NCT01660841: Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects for CNS Imaging
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Magnetic Resonance Imaging
Keywords: Magnetic resonance imaging
central nervous system
contrast media
gadobutrol
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-08-09
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Scores for visualization parameter: degree of contrast enhancement
timeFrame: Day of gadobutrol injection (Day 0)
measure: Scores for visualization parameter: border delineation
timeFrame: Day of gadobutrol injection (Day 0)
measure: Scores for visualization parameter: internal morphology
timeFrame: Day of gadobutrol injection (Day 0)
measure: Number of detected lesions
timeFrame: Day of gadobutrol injection (Day 0)
Secondary outcomes:
measure: Percentage of exact match of the MRI diagnosis with the final clinical diagnosis
timeFrame: Day of gadobutrol injection (Day 0)
measure: Sensitivity and specificity to detect abnormal/normal brain tissue
timeFrame: Day of gadobutrol injection (Day 0)
measure: Sensitivity and specificity to detect malignant Central Nervous System(CNS) lesions
timeFrame: Day of gadobutrol injection (Day 0)
measure: Number of participants with treatment emergent adverse events as a measure of safety and tolerability
timeFrame: 3 days after injection (Day 3)
Other outcomes:
Locations:
city: Nagoya
country: Japan
state: Aichi
city: Funabashi
country: Japan
state: Chiba
city: Kitakyushu
country: Japan
state: Fukuoka
city: Fukuyama
country: Japan
state: Hiroshima
city: Kobe
country: Japan
state: Hyogo
city: Kobe
country: Japan
state: Hyogo
city: Fujisawa
country: Japan
state: Kanagawa
city: Kawasaki
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Daito
country: Japan
state: Osaka
city: Kishiwada
country: Japan
state: Osaka
city: Shimonoseki
country: Japan
state: Yamaguchi
city: Ube
country: Japan
state: Yamaguchi
city: Fukuoka
country: Japan
city: Fukuoka
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: