A Study Comparing Two Magnetic Resonance Imaging (MRI) Contrast Agents in MRI of the Brain
ENHANCE
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
1 other identifier
interventional
114
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2006
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 5, 2006
CompletedFirst Posted
Study publicly available on registry
May 9, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedJanuary 23, 2008
January 1, 2008
May 5, 2006
January 18, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Superiority of Multihance in terms of by-patient global diagnostic performance
immediately post dose
Secondary Outcomes (2)
To compare the two products in terms of by patients global performance for border delineation of lesions; contrast of lesions
immediately post dose
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
immediately post dose
Interventions
Eligibility Criteria
You may qualify if:
- yrs of age or older; provide written informed consent; scheduled to undergo MRI; willing to undergo 2 MRI exams within 14 days
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bracco Diagnostics, Inc.
Princeton, New Jersey, 08540, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Barry Hogstrom, M. D.
Bracco Diagnostics, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 5, 2006
First Posted
May 9, 2006
Study Start
May 1, 2006
Study Completion
March 1, 2007
Last Updated
January 23, 2008
Record last verified: 2008-01