imaging diagnosis of highly suspected or known brain and/or spine disease, which are known to impair the Blood Brain Barrier Function
Conditions
Interventions
Product Name: gadobenate dimeglumine
Pharmaceutical Form: Solution for injection
Sponsors
Bracco Imaging S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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; patients having moderate-to-severe renal impairment, defined as a GFR/eGFR < 60 mL/min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of MULTIHANCE at a dose of 0.1 mmol/kg in MRI of the CNS in pediatric patients, in terms of by lesion changes from predose to pre + postdose with regard to the following co-primary visualization endpoints: - Border delineation of lesions - internal morphology of lesions - Contrast enhancement of lesions To assess the safety of MULTIHANCE at a dose of 0.1 mmol/kg in terms of adverse events and changes in vital signs, ECG findings and laboratory findings.;Secondary Objective: To assess the efficacy of the contrast agent, MULTIHANCE in terms of by lesion and patient changes, where applicable (changes from predose to pre + postdose and/or predose to postdose), with regard to the following endpoints: - Border delineation of lesions - Visualization of internal morphology of lesions - Contrast enhancement of lesions To assess the efficacy of the contrast agent, MULTIHANCE in terms of lesion changes in the Confidence in Diagnosis;Primary end point(s): - Border delineation of lesions - Visualization of internal morphology of lesions - Contrast enhancement of lesions | — |
Countries
Germany, Italy
Outcome results
None listed