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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00323102
Recruitment Status : Completed
First Posted : May 9, 2006
Last Update Posted : January 23, 2008
Sponsor:
Information provided by:
Bracco Diagnostics, Inc

Tracking Information
First Submitted Date  ICMJE May 5, 2006
First Posted Date  ICMJE May 9, 2006
Last Update Posted Date January 23, 2008
Study Start Date  ICMJE May 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2008)
Superiority of Multihance in terms of by-patient global diagnostic performance [ Time Frame: immediately post dose ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 5, 2006)
Superiority of Multihance in terms of by-patient global diagnostic performance
Change History Complete list of historical versions of study NCT00323102 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2006)
  • To compare the two products in terms of by patients global performance for border delineation of lesions; contrast of lesions
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing Two Magnetic Resonance Imaging (MRI) Contrast Agents in MRI of the Brain
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Condition  ICMJE Brain Pathology
Intervention  ICMJE Drug: Multihance
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: May 5, 2006)
114
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00323102
Other Study ID Numbers  ICMJE MH 130
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Bracco Diagnostics, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Barry Hogstrom, M. D. Bracco Diagnostics, Inc
PRS Account Bracco Diagnostics, Inc
Verification Date January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP