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A Study Comparing Two Magnetic Resonance Imaging (MRI) Contrast Agents in MRI of the Brain (ENHANCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00323102
Recruitment Status : Completed
First Posted : May 9, 2006
Last Update Posted : January 23, 2008
Sponsor:
Information provided by:
Bracco Diagnostics, Inc

Study Description
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Brief Summary:
This study aims at a direct comparison between Multihance and a validated comparator like Omniscan in a cross-over individual design in patients with brain tumors to confirm the superior overall diagnostic performance of MuliHance for this indication

Condition or disease Intervention/treatment Phase
Brain Pathology Drug: Multihance Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Official Title: Phase IV, Double-Blind, Multi-Center, Randomized, Cross-Over Study to Compare 0.10 Mmol/kg of MultiHance With 0.10 Omniscan in Magnetic Resonance Imaging (MRI) of the Brain
Study Start Date : May 2006
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Superiority of Multihance in terms of by-patient global diagnostic performance [ Time Frame: immediately post dose ]

Secondary Outcome Measures :
  1. To compare the two products in terms of by patients global performance for border delineation of lesions; contrast of lesions [ Time Frame: immediately post dose ]
  2. To compare the two products in terms of global changes in lesion count; To compare the two products in terms of changes from pre to post dose in signal intensity [ Time Frame: immediately post dose ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 yrs of age or older; provide written informed consent; scheduled to undergo MRI; willing to undergo 2 MRI exams within 14 days

Exclusion Criteria:

  • Known allergy to one or more ingredients in the test agents; severe CHF (Class IV); suffered stroke one year ago; pregnancy or lactating females; contraindications to MRI; severe claustrophobia; scheduled to receive surgery prior to or between the two MRI exams, or steroids or radiosurgery between the two MRI exams
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00323102


Locations
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United States, New Jersey
Bracco Diagnostics, Inc.
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
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Study Director: Barry Hogstrom, M. D. Bracco Diagnostics, Inc
More Information
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ClinicalTrials.gov Identifier: NCT00323102    
Other Study ID Numbers: MH 130
First Posted: May 9, 2006    Key Record Dates
Last Update Posted: January 23, 2008
Last Verified: January 2008