Safety and Efficacy of MultiHance in Pediatric Patients

Bracco

Status and phase: Terminated; Phase 3

Conditions: Central Nervous System Diseases

Treatments: Drug: gadobenate dimeglumine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00323310

MH 110

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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92 participants in 1 patient group

Gadobenate Dimeglumine

Experimental group

Treatment:

Drug: gadobenate dimeglumine