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

Purpose

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.

Condition	Intervention	Phase
Central Nervous System Diseases	Drug: gadobenate dimeglumine	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans Neurologic Diseases

Drug Information available for: Gadopentetate dimeglumine Gadobenate Dimeglumine

U.S. FDA Resources

Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:

Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 1 [ Time Frame: pre-dose and immediately postdose ] [ Designated as safety issue: No ]
5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose
Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 2 [ Time Frame: pre-dose and immediately postdose ] [ Designated as safety issue: No ]
5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose
Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 3 [ Time Frame: pre-dose and immediately postdose ] [ Designated as safety issue: No ]
5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 1 [ Time Frame: pre-dose to immediately post dose ] [ Designated as safety issue: No ]
5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 2 [ Time Frame: pre-dose to immediately post dose ] [ Designated as safety issue: No ]
5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 3 [ Time Frame: pre-dose to immediately postdose ] [ Designated as safety issue: No ]
5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 1 [ Time Frame: pre-dose and immediately postdose ] [ Designated as safety issue: No ]
5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 2 [ Time Frame: pre-dose to immediately postdose ] [ Designated as safety issue: No ]
5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 3 [ Time Frame: pre-dose to immediately postdose ] [ Designated as safety issue: No ]
5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose
The Number of Patients Administered MultiHance (Gadobenate Dimeglumine) Reporting Adverse Events [ Time Frame: up to 72 hours post dose ] [ Designated as safety issue: Yes ]

Enrollment:	92
Study Start Date:	April 2006
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Gadobenate Dimeglumine	Drug: gadobenate dimeglumine A dose of 0.10 mmol/kg (i.e., 0.2 mL/kg) of 0.5 molar MultiHance was injected intravenously at a rate of 2 mL/sec as a single dose. Other Name: MultiHance

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:	Gianpaolo Pirovano, Executive Director, Corporate Medical Development, Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:	NCT00323310 History of Changes
Other Study ID Numbers:	MH 110
Study First Received:	May 5, 2006
Results First Received:	August 16, 2010
Last Updated:	October 13, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bracco Diagnostics, Inc:

disease of the central nervous system (brain or spine)

Additional relevant MeSH terms:

Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013