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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Chiba Tokushukai Hospital Funabashi, Japan, 274-8503 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kawasaki Municipal Hospital Kawasaki, Japan, 210-0013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yokohama Shinmidori General Hospital Yokohama, Japan, 226-0025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fujisawa City Hospital Fujisawa, Japan, 251-8550 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chubu Rosai Hospital Nagoya, Japan, 455-8530 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nozaki Tokushukai Hospital Daito, Japan, 574-0074 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kishiwada Tokushukai Hospital Kishiwada, Japan, 596-8522 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institute of Biomedical Research and Innovation Kobe, Japan, 650-0047 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shinsuma Hospital Kobe, Japan, 654-0047 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ube Industries Central Hospital Ube, Japan, 755-0151 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shimonoseki Kosei Hospital Shimonoseki, Japan, 750-0061 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fukuokaken Saiseikai Fukuoka General Hospital Fukuoka, Japan, 810-0001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shinkomonji Hospital Kitakyushu, Japan, 800-0057 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fukuoka Wajiro Hospital Fukuoka, Japan, 811-0213 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Brain Attack Center Oota Memorial Hospital Fukuyama, Japan, 720-0825 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Diagnostic
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Scores for visualization parameter: degree of contrast enhancementBlinded 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.Timeframe: Day of gadobutrol injection (Day 0)
- Scores for visualization parameter: border delineationBlinded 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.Timeframe: Day of gadobutrol injection (Day 0)
- Scores for visualization parameter: internal morphologyBlinded 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.Timeframe: Day of gadobutrol injection (Day 0)
- Number of detected lesionsBlinded readers determine number of detected lesions in scans with and without gadobutrol.Timeframe: Day of gadobutrol injection (Day 0)
Secondary Outcome
- Percentage of exact match of the MRI diagnosis with the final clinical diagnosisAn exact match is defined as identical diagnosis given by the blinded reader and the independent standard of truth committee.Timeframe: Day of gadobutrol injection (Day 0)
- Sensitivity and specificity to detect abnormal/normal brain tissueBlinded readers classify the brain tissue as normal or abnormal based on the MRI sets.Timeframe: Day of gadobutrol injection (Day 0)
- Sensitivity and specificity to detect malignant Central Nervous System(CNS) lesionsPercentage 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.Timeframe: Day of gadobutrol injection (Day 0)
- Number of participants with treatment emergent adverse events as a measure of safety and tolerabilityTimeframe: 3 days after injection (Day 3)
Additional Information
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