Clinical trial NCT00323310: Safety and Efficacy of MultiHance in Pediatric Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Central Nervous System Diseases
Keywords: disease of the central nervous system (brain or spine)
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2006-05-09
Enrollment: 92
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study was to assess the safety and enhancing properties of the magnetic resonance imaging (MRI) contrast agent MultiHance in children aged 2 to 17 years having central nervous system (CNS) disorders.


Eligibility criteria: Inclusion Criteria:

* Between 2 and 17 years of age
* Informed consent from parents
* Assent from patient where required
* Known or highly suspected disease of the CNS and referred for either cranial or spinal MRI examination

Exclusion Criteria:

* Contraindication to MRI
* Undergoing MRI in an emergency situation
* Known allergy to one or more of the ingredients in MultiHance
* Sickle cell anemia moderate to severe renal impairment
* Received another investigational compound within 30 days
* Pregnancy
* Lactating females
* Likely to undergo an invasive procedure within 72 hours of receiving MultiHance

Primary outcomes:
measure: Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 1
timeFrame: pre-dose and immediately postdose
measure: Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 2
timeFrame: pre-dose and immediately postdose
measure: Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 3
timeFrame: pre-dose and immediately postdose
measure: Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 1
timeFrame: pre-dose to immediately post dose
measure: Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 2
timeFrame: pre-dose to immediately post dose
measure: Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 3
timeFrame: pre-dose to immediately postdose
measure: Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 1
timeFrame: pre-dose and immediately postdose
measure: Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 2
timeFrame: pre-dose to immediately postdose
measure: Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 3
timeFrame: pre-dose to immediately postdose
measure: The Number of Patients Administered MultiHance (Gadobenate Dimeglumine) Reporting Adverse Events
timeFrame: up to 72 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Bracco Diagnostics, Inc.
state: New Jersey
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Gianpaolo Pirovano, M.D.
role: STUDY_DIRECTOR
References: