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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


Phase 4
18 Years
N/A
Not Enrolling
Both
Brain Pathology

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind

Outcome Measure:

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

Outcome Time Frame:

immediately post dose

Safety Issue:

No

Principal Investigator

Barry Hogstrom, M. D.

Investigator Role:

Study Director

Investigator Affiliation:

Bracco Diagnostics, Inc

Authority:

United States: Food and Drug Administration

Study ID:

MH 130

NCT ID:

NCT00323102

Start Date:

May 2006

Completion Date:

March 2007

Related Keywords:

  • Brain Pathology
  • Brain Diseases

Name

Location

Bracco Diagnostics, Inc.Princeton, New Jersey  08540