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

Brain Pathology Clinical Trial

— ENHANCE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00323102
• Other study ID #: MH 130
• Status: Completed
• Phase: Phase 4
• First received: May 5, 2006
• Last updated: January 18, 2008
• Start date: May 2006
• Est. completion date: March 2007

Study information

• Verified date: January 2008
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Brain Pathology

Intervention

Drug:
• Multihance

Locations

Country	Name	City	State
United States	Bracco Diagnostics, Inc.	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Superiority of Multihance in terms of by-patient global diagnostic performance		immediately post dose	No
Secondary	To compare the two products in terms of by patients global performance for border delineation of lesions; contrast of lesions		immediately post dose	No
Secondary	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		immediately post dose	No