Trial Outcomes & Findings for Safety and Efficacy of MultiHance in Pediatric Patients (NCT NCT00323310)
NCT ID: NCT00323310
Last Updated: 2010-10-22
Results Overview
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
TERMINATED
PHASE3
92 participants
pre-dose and immediately postdose
2010-10-22
Participant Flow
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.
94 patients enrolled; 92 patients dosed.
Participant milestones
| Measure |
Gadobenate Dimeglumine
Contrast Agent, 0.10 mmol/kg injection
|
|---|---|
|
Overall Study
STARTED
|
92
|
|
Overall Study
COMPLETED
|
89
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Gadobenate Dimeglumine
Contrast Agent, 0.10 mmol/kg injection
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
a parent refused blood draw
|
1
|
|
Overall Study
did not complete the 24-hr f-up visit
|
1
|
Baseline Characteristics
Safety and Efficacy of MultiHance in Pediatric Patients
Baseline characteristics by cohort
| Measure |
Gadobenate Dimeglumine
n=92 Participants
Contrast Agent, 0.10 mmol/kg injection
|
|---|---|
|
Age, Categorical
<=18 years
|
92 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
10.59 years
STANDARD_DEVIATION 4.017 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
47 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
|
Region of Enrollment
China
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: pre-dose and immediately postdosePopulation: 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.
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
Outcome measures
| Measure |
Gadobenate Dimeglumine
n=148 Lesions
Contrast Agent, 0.10 mmol/kg injection
|
|---|---|
|
Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 1
Predose
|
1.7 Units on a Scale (0 to 4)
Standard Deviation 1.16
|
|
Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 1
Pre+Postdose
|
3.0 Units on a Scale (0 to 4)
Standard Deviation 1.20
|
PRIMARY outcome
Timeframe: pre-dose and immediately postdosePopulation: 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.
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
Outcome measures
| Measure |
Gadobenate Dimeglumine
n=135 Lesions
Contrast Agent, 0.10 mmol/kg injection
|
|---|---|
|
Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 2
Predose
|
1.9 Units on a Scale (0 to 4)
Standard Deviation 1.15
|
|
Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 2
Pre+Postdose
|
3.1 Units on a Scale (0 to 4)
Standard Deviation 1.11
|
PRIMARY outcome
Timeframe: pre-dose and immediately postdosePopulation: 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.
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
Outcome measures
| Measure |
Gadobenate Dimeglumine
n=131 Lesions
Contrast Agent, 0.10 mmol/kg injection
|
|---|---|
|
Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 3
Predose
|
1.7 Units on a Scale (0 to 4)
Standard Deviation 1.19
|
|
Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 3
Pre+Postdose
|
2.4 Units on a Scale (0 to 4)
Standard Deviation 1.12
|
PRIMARY outcome
Timeframe: pre-dose to immediately post dosePopulation: 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.
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
Outcome measures
| Measure |
Gadobenate Dimeglumine
n=148 Lesions
Contrast Agent, 0.10 mmol/kg injection
|
|---|---|
|
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 1
Predose
|
1.9 Units on a Scale (0 to 4)
Standard Deviation 1.18
|
|
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 1
Pre+Postdose
|
3.2 Units on a Scale (0 to 4)
Standard Deviation 1.19
|
PRIMARY outcome
Timeframe: pre-dose to immediately post dosePopulation: 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.
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
Outcome measures
| Measure |
Gadobenate Dimeglumine
n=135 Lesions
Contrast Agent, 0.10 mmol/kg injection
|
|---|---|
|
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 2
Predose
|
2.1 Units on a Scale (0 to 4)
Standard Deviation 1.17
|
|
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 2
Pre+Postdose
|
3.2 Units on a Scale (0 to 4)
Standard Deviation 1.13
|
PRIMARY outcome
Timeframe: pre-dose to immediately postdosePopulation: 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.
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
Outcome measures
| Measure |
Gadobenate Dimeglumine
n=131 Lesions
Contrast Agent, 0.10 mmol/kg injection
|
|---|---|
|
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 3
Predose
|
1.4 Units on a Scale (0 to 4)
Standard Deviation 1.06
|
|
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 3
Pre+Postdose
|
2.0 Units on a Scale (0 to 4)
Standard Deviation 1.23
|
PRIMARY outcome
Timeframe: pre-dose and immediately postdosePopulation: 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.
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
Outcome measures
| Measure |
Gadobenate Dimeglumine
n=148 Lesions
Contrast Agent, 0.10 mmol/kg injection
|
|---|---|
|
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 1
Predose
|
1.8 Units on a Scale (0 to 4)
Standard Deviation 1.16
|
|
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 1
Pre+Postdose
|
3.0 Units on a Scale (0 to 4)
Standard Deviation 1.19
|
PRIMARY outcome
Timeframe: pre-dose to immediately postdosePopulation: 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.
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
Outcome measures
| Measure |
Gadobenate Dimeglumine
n=135 Lesions
Contrast Agent, 0.10 mmol/kg injection
|
|---|---|
|
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 2
Predose
|
2.0 Units on a Scale (0 to 4)
Standard Deviation 1.20
|
|
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 2
Pre+Postdose
|
3.2 Units on a Scale (0 to 4)
Standard Deviation 1.12
|
PRIMARY outcome
Timeframe: pre-dose to immediately postdosePopulation: 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.
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
Outcome measures
| Measure |
Gadobenate Dimeglumine
n=131 Lesions
Contrast Agent, 0.10 mmol/kg injection
|
|---|---|
|
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 3
Predose
|
1.4 Units on a Scale (0 to 4)
Standard Deviation 0.96
|
|
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 3
Pre+Postdose
|
2.2 Units on a Scale (0 to 4)
Standard Deviation 1.41
|
PRIMARY outcome
Timeframe: up to 72 hours post dosePopulation: Included all dosed patients (safety population).
Outcome measures
| Measure |
Gadobenate Dimeglumine
n=92 Participants
Contrast Agent, 0.10 mmol/kg injection
|
|---|---|
|
The Number of Patients Administered MultiHance (Gadobenate Dimeglumine) Reporting Adverse Events
|
8 Participants
|
Adverse Events
Gadobenate Dimeglumine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gadobenate Dimeglumine
n=92 participants at risk
Contrast Agent, 0.10 mmol/kg injection
|
|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.1%
1/92 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/92 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.1%
1/92 • Number of events 1
|
|
Eye disorders
Eyelid oedema
|
1.1%
1/92 • Number of events 1
|
|
Nervous system disorders
Headache
|
2.2%
2/92 • Number of events 2
|
|
Infections and infestations
Otitis media
|
1.1%
1/92 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
1.1%
1/92 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/92 • Number of events 1
|
Additional Information
Usha Halemane/Executive Director
Bracco Diagnostics Inc
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER