Contrast-enhanced MRI of the CNS
Conditions
Interventions
investigational material(s)
Generic name etc : BAY 1747846
INN of investigational material : -
Therapeutic category code : 729 Other diagnostic agents (except extracorporeal diagnostic medicines)
Dosa
Sponsors
Bayer Yakuhin, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participant must be at least 18 years of age at the time of signing the informed consent. - Known or highly suspected CNS pathology (contrast-enhancing CNS lesion) referred for contrast-enhanced MRI of the CNS. - Male and female. - Estimated glomerular filtration rate (eGFR) value >=60 mL/min/1.73m2.
Exclusion criteria
Exclusion criteria: - Considered clinically unstable. - Severe cardiovascular disease. - Any contraindication to MRI examinations. - History of severe allergic or anaphylactic/anaphylactoid reaction to any allergen including drugs and contrast agents. - History of allergic asthma. - Suspected lesions or suffering from any of the following CNS diseases/lesion types as the main indication for MRI: - Meningeal disease (focal enhancement) - Pituitary adenomas (macro and micro) - Tumors of the choroid plexus - Tumors of the pineal gland - Dermoid/epidermoid tumors - Infectious disease (e.g. brain abscess, cisticercosis, etc.) - Venous angiomas - Subacute/chronic ischemia - Encephalitis - Multiple sclerosis (acute and chronic) - Optic neuritis - Chordomas - Von Hippel Lindau syndrome - Hypertensive leukoencephalopathy. - Receipt of any contrast agent <72 h prior to the study MRIs, or planned receipt of any contrast agent within 72 h after the second study MRI. - Planned or expected biopsy or any interventional therapeutic procedure from the first study MRI up to 24 h after the second study MRI. - Planned or expected change in any treatment or procedure between the two study MRIs that may alter image comparability and /or chemotherapy which is changed between the two MRI procedures. - Contraindications to the administration of gadobutrol (depending on local product label).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy Overall diagnostic preference [ Time Frame: At 5 minute post injection ] [ Designated as safety issue: ] | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Sum of lesion visualization parameters [ Time Frame: At 5 minute post injection ] [ Designated as safety issue: ] | — |
Countries
Europe, Japan, North America
Outcome results
None listed