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Adequate statistical power at 92 dosed pts to meet study objectives.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gadobenate Dimeglumine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gadobenate dimeglumine | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gianpaolo Pirovano, M.D. | Bracco Diagnostics, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bracco Diagnostics, Inc. | Princeton | New Jersey | 08540 | United States |
94 patients enrolled; 92 patients dosed.
Patients were recruited from April 2006 to July 2008 at 17 investigational sites. The blinded read was conducted from September 12, 2008 to September 26, 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gadobenate Dimeglumine | Contrast Agent, 0.10 mmol/kg injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gadobenate Dimeglumine | Contrast Agent, 0.10 mmol/kg injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. | Posted | Mean | Standard Deviation | Units on a Scale (0 to 4) | pre-dose and immediately postdose | Lesions | Participants |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gadobenate Dimeglumine | Contrast Agent, 0.10 mmol/kg injection |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Usha Halemane/Executive Director | Bracco Diagnostics Inc | 609-514-2578 | usha.halemane@diag.bracco.com |
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| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C064572 | gadobenic acid |
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|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| The Number of Patients Administered MultiHance (Gadobenate Dimeglumine) Reporting Adverse Events | up to 72 hours post dose |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Contrast Agent, 0.10 mmol/kg injection |
|
|
|
| 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 | Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. | Posted | Mean | Standard Deviation | Units on a Scale (0 to 4) | pre-dose and immediately postdose | Lesions | Participants |
|
|
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| 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 | Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. | Posted | Mean | Standard Deviation | Units on a Scale (0 to 4) | pre-dose and immediately postdose | Lesions | Participants |
|
|
|
|
| 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 | Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. | Posted | Mean | Standard Deviation | Units on a Scale (0 to 4) | pre-dose to immediately post dose | Lesions | Participants |
|
|
|
|
| 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 | Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. | Posted | Mean | Standard Deviation | Units on a Scale (0 to 4) | pre-dose to immediately post dose | Lesions | Participants |
|
|
|
|
| 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 | Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. | Posted | Mean | Standard Deviation | Units on a Scale (0 to 4) | pre-dose to immediately postdose | Lesions | Participants |
|
|
|
|
| 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 | Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. | Posted | Mean | Standard Deviation | Units on a Scale (0 to 4) | pre-dose and immediately postdose | Lesions | Participants |
|
|
|
|
| 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 | Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. | Posted | Mean | Standard Deviation | Units on a Scale (0 to 4) | pre-dose to immediately postdose | Lesions | Participants |
|
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| 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 | Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. | Posted | Mean | Standard Deviation | Units on a Scale (0 to 4) | pre-dose to immediately postdose | Lesions | Participants |
|
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|
|
| Primary | The Number of Patients Administered MultiHance (Gadobenate Dimeglumine) Reporting Adverse Events | Included all dosed patients (safety population). | Posted | Number | Participants | up to 72 hours post dose |
|
|
|
| 0 |
| 92 |
| 8 |
| 92 |
| Constipation | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA (10.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
The results of the study may be presented during scientific symposia or published in a scientific journal only after review by Bracco in accordance with the guidelines set forth in the applicable publication or financial agreement.