Magnetic Resonance Imaging
Conditions
Keywords
Magnetic Resonance Imaging (MRI), Observational study, Gadobutrol
Brief summary
Patients will be recruited from those who will undergo contrast enhanced MRI. Safety and tolerability will be assessed.
Interventions
Patients who will need to undergo contrast enhanced MRI with gadobutrol (Gadovist)
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years old and above undergoing contrast enhanced cranial or spinal MRI with Gadobutrol (Gadovist)
Exclusion criteria
* History of hypersensitivity reaction to gadolinium containing contrast material * Hypersensitivity to any of the ingredients of Gadobutrol (Gadovist) * History of hypersensitivity to any other contrast agent * Patients with uncorrected hypokalemia * Pregnant and lactating women * Patients with severe cardiovascular diseases * Patients in whom MRI cannot be performed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures would be safety and tolerability of Gadovist which would be measured by change in Vital signs before and after the procedure and the occurrence of serious or non-serious adverse events | Up to 1 hour after MRI |
Other
| Measure | Time frame |
|---|---|
| Magnetic field strength of MRI | During the procedure |
| Volume of contrast agent used | During the procedure |
Countries
Philippines
Outcome results
None listed