The 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 MR images of the body/extremities regions. The results of the MRI with gadobutrol injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with Magnevist.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
370
Single administration at a dose of 0.1 mmol/kg
Single administration at a dose of 0.1 mmol/kg
Unnamed facility
Nanjing, Jiangsu, China
Unnamed facility
Suzhou, Jiangsu, China
Unnamed facility
Xi’an, Shanxi, China
Unnamed facility
The total score of the following 3 visualization parameters is used for primary variable: Degree of contrast enhancement; Border delineation; Internal morphology.
Time frame: At Day 0
Sensitivity and specificity for the detection of malignant lesions
Time frame: At Day 0
Exact match of the MR diagnosis with the final clinical diagnosis based on medical records up until 3 months after the scan
Time frame: At Day 0
Confidence in diagnosis
Time frame: At Day 0
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Beijing, China
Unnamed facility
Shanghai, China
Unnamed facility
Shanghai, China
Unnamed facility
Kamogawa, Chiba, Japan
Unnamed facility
Matsuyama, Ehime, Japan
Unnamed facility
Chikushino-shi, Fukuoka, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
...and 5 more locations