Central Nervous System Pathology
Conditions
Brief summary
Compare relative exposure in the younger age group in order to supplement the PK profile already determined in older children and adults
Interventions
DRUGMultihance
0.5M administered as a single injection
Sponsors
Bracco Diagnostics, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
* Male or female between 2 and 5 years of age * Obtained informed consent from patient's parent or guardian * Obtain assent when applicable according to local law * Known or suspected disease of the central nervous system (brain or spine) * Referred for MRI of the brain or spine requiring an injection of an MR contrast agent
Exclusion criteria
* Contraindications to MR examination * Undergoing MRI in an emergency situation * Known allergy to one or more ingredients in the contrast agent or history of hypersensitivity to gadolinium or metals * Sickle cell anemia * Likely to undergo an invasive examination within 72 hours after administration of the investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the blood PK of Multihance in patients from 2 to 5 years of age | up to 24 hours post dose |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the safety of Multihance in patients from 2 to 5 years of age | through 72 hours post dose |
Countries
Poland
Outcome results
None listed