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Completed

NCT Number: NCT00323102

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

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

Completed

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Key information

Conditions

Brain Pathology

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bracco Diagnostics, Inc.

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multihance

Drug

Primary outcomes

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

    Time frame: immediately post dose

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bracco Diagnostics, Inc

Industry

Registry information

Official study 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

Acronym: ENHANCE

Important dates

Study start
2006
Study completion
2007
First posted
May 9, 2006
Registry last updated
Jan 23, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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