Safety and Efficacy of MultiHance in Pediatric Patients

Central Nervous System Diseases Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00323310
• Other study ID #: MH 110
• Status: Terminated
• Phase: Phase 3
• First received: May 5, 2006
• Last updated: October 13, 2010
• Start date: April 2006
• Est. completion date: September 2008

Study information

• Verified date: October 2010
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 92
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Central Nervous System Diseases
• Nervous System Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Bracco Diagnostics, Inc.	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 1	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	pre-dose and immediately postdose	No
Primary	Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 2	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	pre-dose and immediately postdose	No
Primary	Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 3	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	pre-dose and immediately postdose	No
Primary	Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 1	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	pre-dose to immediately post dose	No
Primary	Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 2	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	pre-dose to immediately post dose	No
Primary	Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 3	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	pre-dose to immediately postdose	No
Primary	Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 1	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	pre-dose and immediately postdose	No
Primary	Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 2	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	pre-dose to immediately postdose	No
Primary	Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 3	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	pre-dose to immediately postdose	No
Primary	The Number of Patients Administered MultiHance (Gadobenate Dimeglumine) Reporting Adverse Events		up to 72 hours post dose	Yes