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

Bracco Diagnostics, Inc114 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

114

Conditions

Brain Pathology

Interventions

MultihanceDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Bracco Diagnostics, Inc.

Princeton, New Jersey, United States

Outcomes

Primary Outcomes

Superiority of Multihance in terms of by-patient global diagnostic performance

Time frame: immediately post dose

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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