Safety and Efficacy of MultiHance in Pediatric Patients

This study has been terminated.

( Adequate statistical power at 92 dosed pts to meet study objectives. )

Study NCT00323310 Information provided by Bracco Diagnostics, Inc

First Received on May 5, 2006. Last Updated on October 13, 2010 History of Changes

Results First Received: August 16, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Diagnostic
Condition:	Central Nervous System Diseases
Intervention:	Drug: gadobenate dimeglumine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
94 patients enrolled; 92 patients dosed.

Reporting Groups

	Description
Gadobenate Dimeglumine	Contrast Agent, 0.10 mmol/kg injection

Participant Flow: Overall Study

	Gadobenate Dimeglumine
STARTED	92
COMPLETED	89
NOT COMPLETED	3
Withdrawal by Subject	1
a parent refused blood draw	1
did not complete the 24-hr f-up visit	1

Baseline Characteristics

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Reporting Groups

	Description
Gadobenate Dimeglumine	Contrast Agent, 0.10 mmol/kg injection

Baseline Measures

	Gadobenate Dimeglumine
Number of Participants [units: participants]	92
Age [units: participants]
<=18 years	92
Between 18 and 65 years	0
>=65 years	0
Age [units: years] Mean ± Standard Deviation	10.59 ± 4.017
Gender [units: participants]
Female	47
Male	45
Region of Enrollment [units: participants]
United States	35
Europe	47
Canada	1
China	9

Outcome Measures

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1. Primary:

Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 1 [ Time Frame: pre-dose and immediately postdose ]

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2. Primary:

Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 2 [ Time Frame: pre-dose and immediately postdose ]

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3. Primary:

Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 3 [ Time Frame: pre-dose and immediately postdose ]

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4. Primary:

Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 1 [ Time Frame: pre-dose to immediately post dose ]

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5. Primary:

Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 2 [ Time Frame: pre-dose to immediately post dose ]

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6. Primary:

Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 3 [ Time Frame: pre-dose to immediately postdose ]

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7. Primary:

Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 1 [ Time Frame: pre-dose and immediately postdose ]

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8. Primary:

Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 2 [ Time Frame: pre-dose to immediately postdose ]

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9. Primary:

Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 3 [ Time Frame: pre-dose to immediately postdose ]

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10. Primary:

The Number of Patients Administered MultiHance (Gadobenate Dimeglumine) Reporting Adverse Events [ Time Frame: up to 72 hours post dose ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Usha Halemane/Executive Director
Organization: Bracco Diagnostics Inc
phone: 609-514-2578
e-mail: usha.halemane@diag.bracco.com

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