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A Phase IV Double-blind Multicenter Randomized Crossover Study to Compare 0.10 mmol/kg of Multihance With 0.10 mmol.kg of Magnevist in Magnetic Resonance Imaging(MRI) of the Brain at 3T


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

Thank you

Trial Information

A Phase IV Double-blind Multicenter Randomized Crossover Study to Compare 0.10 mmol/kg of Multihance With 0.10 mmol.kg of Magnevist in Magnetic Resonance Imaging(MRI) of the Brain at 3T


Inclusion Criteria:



- 18 years or older

- Provide written informed consent

- Scheduled for MRI

- Confirmed or highly suspected to have brain tumor(s) and willing to undergo two MRI
exams within 14 days

Exclusion Criteria:

- Pregnant or lactating females

- Allergy to one or more of the ingredients in the products or hypersensitivity to any
metals

- Congestive heart failure, class IV

- Previous stroke in the past year

- Received another contrast agent within 24 hours pre and post each exam

- Investigational product

- Contraindications to MRI

- Severe claustrophobia

- Surgery with 3 weeks prior

- Steroid therapy or radiosurgery between two exams

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

Global Diagnostic Preference Between the Two Exams

Outcome Description:

Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferreed, both contrast agents were equal, or the image with Magnevist was preferred.

Outcome Time Frame:

Postdose Images for MultiHance Exam and for Magnevist Exam Compared

Safety Issue:

No

Principal Investigator

Gianpaolo Priovano, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Bracco Diagnostics, Inc

Authority:

United States: Institutional Review Board

Study ID:

MH 126

NCT ID:

NCT00395863

Start Date:

November 2006

Completion Date:

March 2008

Related Keywords:

  • Brain Tumor
  • Brain Neoplasms

Name

Location

Bracco Diagnostics, Inc.Princeton, New Jersey  08540