Magnetic Resonance Imaging
Conditions
Keywords
Magnetic resonance imaging, central nervous system, contrast media, gadobutrol
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).
Interventions
A single bolus injection of gadobutrol 1.0M 0.1mmol/kg body weight.
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of detected lesions | Day of gadobutrol injection (Day 0) | Blinded readers determine number of detected lesions in scans with and without gadobutrol. |
| Scores for visualization parameter: degree of contrast enhancement | Day of gadobutrol injection (Day 0) | Blinded 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. |
| Scores for visualization parameter: border delineation | Day of gadobutrol injection (Day 0) | Blinded 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. |
| Scores for visualization parameter: internal morphology | Day of gadobutrol injection (Day 0) | Blinded 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of exact match of the MRI diagnosis with the final clinical diagnosis | Day of gadobutrol injection (Day 0) | An exact match is defined as identical diagnosis given by the blinded reader and the independent standard of truth committee. |
| Sensitivity and specificity to detect abnormal/normal brain tissue | Day of gadobutrol injection (Day 0) | Blinded readers classify the brain tissue as normal or abnormal based on the MRI sets. |
| Sensitivity and specificity to detect malignant Central Nervous System(CNS) lesions | Day of gadobutrol injection (Day 0) | Percentage 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. |
| Number of participants with treatment emergent adverse events as a measure of safety and tolerability | 3 days after injection (Day 3) | — |
Countries
Japan
Outcome results
None listed