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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
92
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.
Bracco Diagnostics, Inc.
Princeton, New Jersey, United States
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
Time frame: pre-dose and immediately postdose
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
Time frame: pre-dose and immediately postdose
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
Time frame: pre-dose and immediately postdose
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 1
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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
Time frame: pre-dose to immediately post dose
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
Time frame: pre-dose to immediately post dose
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
Time frame: pre-dose to immediately postdose
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
Time frame: pre-dose and immediately postdose
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
Time frame: pre-dose to immediately postdose
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
Time frame: pre-dose to immediately postdose
The Number of Patients Administered MultiHance (Gadobenate Dimeglumine) Reporting Adverse Events
Time frame: up to 72 hours post dose