A PHASE III, MULTI-CENTER, OPEN-LABEL STUDY TO EVALUATE SAFETY AND EFFICACY OF MULTIHANCE® AT THE DOSE OF 0.10 mmol/kg IN MAGNETIC RESONANCE IMAGING OF THE CENTRAL NERVOUS SYSTEM IN PEDIATRIC PATIENTS. - MRI in Pediatric CNS

• Conditions: imaging diagnosis of highly suspected or known brain and/or spine disease, which are known to impair the Blood Brain Barrier Function

• Registration Number: EUCTR2005-004170-25-BE
• Lead Sponsor: Bracco Imaging S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-19
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

All the patients aging between 2 and 17 years,which have known or highly suspected disease of the CNS (brain/spine) and are referred for cranial or spinal MR examination requiring an injection of MR contrast agent and give their consent (or have their parents' consent)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Are excluded from this study all the following patients: - Have any contraindications to an MR examination - Are undergoing the MR examination in an emergency situation; - Have any known allergy to one or more of the ingredients in the study contrast agents; or have a history of hypersensitivity to any metals or chelates of gadolinium; - Have received any other contrast medium, either intra-vascularly or orally, within the 48 hours before and up to 72 hours following the administration of the investigational product; - Are likely to undergo an invasive examination or intervention within72 hours after the administration of the investigational product; - Have received or have been scheduled to receive an investigational compound and/or medical device within 30 days prior to admission into this study or within 72 hours post-administration of the investigational product; - Are a female who is lactating or pregnant (for females who have started menses; the possibility of pregnancy must be excluded by serum or urine beta-HCG on-site within 24 hours prior to the investigational product administration); - Have sicle cell anemia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified