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Sponsored by: |
Bracco Diagnostics, Inc |
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Information provided by: | Bracco Diagnostics, Inc |
ClinicalTrials.gov Identifier: | NCT00323102 |
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 IV |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 114 |
Study Start Date: | May 2006 |
Study Completion Date: | March 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New Jersey | |
Bracco Diagnostics, Inc. | |
Princeton, New Jersey, United States, 08540 |
Study Director: | Barry Hogstrom, M. D. | Bracco Diagnostics, Inc |
Study ID Numbers: | MH 130 |
Study First Received: | May 5, 2006 |
Last Updated: | January 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00323102 |
Health Authority: | United States: Food and Drug Administration |
Central Nervous System Diseases Brain Diseases |
Nervous System Diseases |