Safety and Efficacy of MultiHance in Pediatric Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

May 5, 2006

Last Updated Date

February 18, 2010

Start Date ^ICMJE

April 2006

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To assess efficacy of MultiHance in MRI of the CNS in pediatric patients in terms of lesion changes pre to pre plus post dose in terms of border delineation of lesions [ Time Frame: immediately post dose ] [ Designated as safety issue: No ]
To assess the safety of MultiHance in terms of adverse events, changes in vital signs, electrocardiograms (ECGs) and laboratory findings [ Time Frame: up to 72 hours post dose ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

To assess efficacy of MultiHance in MRI of the CNS in pediatric patients in terms of by lesion changes pre to pre plus post dose in terms of border delineation of lesions; visualization of morphology of lesions and contrast enhancement;
To assess the safety of Multihance in terms of adverse events, changes in vital signs, ECGs and laboratory findings

Change History

Complete list of historical versions of study NCT00323310 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Efficacy by patient and by lesion changes from pre to pre plus post dose and pre to post dose in regard to border delineation [ Time Frame: immedidately post dose ] [ Designated as safety issue: No ]
Morphology and contrast enhancement of lesions [ Time Frame: immediately post dose ] [ Designated as safety issue: No ]
To assess efficacy in terms of confidence in diagnosis [ Time Frame: immediately post dose ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Efficacy in by patient and by lesions changes from pre to pre+ post dose and pre to post dose in regard to border delineation; morphology and contrast enhancement of lesions; to assess efficacy in terms of confidence in diagnosis

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of MultiHance in Pediatric Patients

Official Title ^ICMJE

A Phase III Multi-Center Open Label Study to Evaluate Safety and Efficacy of MultiHance at the Dose of 0.10mmol/kg in Magnetic Resonance Imaging of the Central Nervous System in Pediatric Patients

Brief Summary

The purpose of this study is 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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Non-Randomized
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Single Group Assignment
Masking:  Open Label
Primary Purpose:  Diagnostic

Condition ^ICMJE

Central Nervous System Diseases

Intervention ^ICMJE

Drug: gadobenate dimeglumine

0.5 M for injection single dose

Study Arms / Comparison Groups

A: Experimental

Intervention: Drug: gadobenate dimeglumine

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

2 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00323310

Responsible Party

Gianpaolo Pirovano, Executive Director, Corporate Medical Development, Bracco Diagnostics, Inc

Study ID Numbers ^ICMJE

MH 110

Study Sponsor ^ICMJE

Bracco Diagnostics, Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Gianpaolo Pirovano, M.D.

Bracco Diagnostics, Inc

Information Provided By

Bracco Diagnostics, Inc

Verification Date

February 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP