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

This study has been completed.
Sponsor:
Information provided by:
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT00323102
First received: May 5, 2006
Last updated: January 18, 2008
Last verified: January 2008
History of Changes
  Purpose

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 Intervention Phase
Brain Pathology
 Drug: Multihance
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans
U.S. FDA Resources

Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • Superiority of Multihance in terms of by-patient global diagnostic performance [ Time Frame: immediately post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 114
Study Start Date: May 2006
Study Completion Date: March 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323102

Locations
United States, New Jersey
Bracco Diagnostics, Inc.
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
Study Director: Barry Hogstrom, M. D. Bracco Diagnostics, Inc
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00323102     History of Changes
Other Study ID Numbers: MH 130
Study First Received: May 5, 2006
Last Updated: January 18, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013