Safety and Efficacy of MultiHance in Pediatric Patients - Full Text View

Sponsored by:	Bracco Diagnostics, Inc
Information provided by:	Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:	NCT00323310

Purpose

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.

Condition	Intervention	Phase
Central Nervous System Diseases	Drug: gadobenate dimeglumine	Phase III

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans Neurologic Diseases

Drug Information available for: Gadobenic acid Gadobenate Dimeglumine

U.S. FDA Resources

Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	188
Study Start Date:	April 2006
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: gadobenate dimeglumine 0.5 M for injection single dose

Eligibility

Ages Eligible for Study:	2 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323310

Locations

United States, New Jersey
Bracco Diagnostics, Inc.
Princeton, New Jersey, United States, 08540

Sponsors and Collaborators

Bracco Diagnostics, Inc

Investigators

Study Director:

Gianpaolo Pirovano, M.D.

Bracco Diagnostics, Inc

More Information

No publications provided

Responsible Party:	Bracco Diagnostics, Inc ( Gianpaolo Pirovano, Executive Director, Corporate Medical Development )
Study ID Numbers:	MH 110
Study First Received:	May 5, 2006
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00323310 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bracco Diagnostics, Inc:

disease of the central nervous system (brain or spine)

Study placed in the following topic categories:

Central Nervous System Diseases

Additional relevant MeSH terms:

Nervous System Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on July 02, 2009