This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Bracco Diagnostics, Inc Identifier:
First received: May 5, 2006
Last updated: January 18, 2008
Last verified: January 2008
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
Intervention Model: Crossover Assignment
Masking: Double
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:

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 ]

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 ]
  • 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 ]

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00323102

United States, New Jersey
Bracco Diagnostics, Inc.
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Bracco Diagnostics, Inc
Study Director: Barry Hogstrom, M. D. Bracco Diagnostics, Inc
  More Information Identifier: NCT00323102     History of Changes
Other Study ID Numbers: MH 130
Study First Received: May 5, 2006
Last Updated: January 18, 2008 processed this record on September 21, 2017