Crossover Study With MultiHance vs a Comparator for Peripheral MRA

March 25, 2009 updated by: Bracco Diagnostics, Inc

A Phase IIIB, Double-Blind, Multi-Center, Randomized, Cross-Over Study to Compare 0.1 Mmol/kg of Multihance With 0.1 Mmol/kg of Magnevist for Contrast-Enhanced Magnetic Resonance Angiography(CE-MRA) of Peripheral Arteries

This is a double blind crossover study designed to compare two different gadolinium products given at the same dose to patients undergoing MRA assessment of lower legs for the evaluation of peripheral steno-occlusive disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20134
        • Bracco Imaging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent
  • At least 18 yrs of age
  • Moderate to severe peripheral arterial disease
  • Willing to undergo two MRA procedures within 14 days

Exclusion Criteria:

  • Pregnant or lactating
  • Known allergies to one or more ingredients in the products
  • Therapeutic intervention in the arterial territory of interest between the two MRA exams
  • Changes in symptoms between the two exams
  • Vascular stent in area of interest
  • Severe claustrophobia
  • Congestive heart failure class IV
  • Scheduled to undergo surgery for PAOD between the two exams
  • Scheduled to undergo DSA between the two exams

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
MultiHance MRI contrast agent
Drug: MultiHance
0.5 mmol/kg as a single dose administration
Active Comparator: 2
Magnevist contrast agent for MRA
Drug: Magnevist
0.5 mmol/kg as a single dose administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of global paired diagnostic preference of the two MRA exams
Time Frame: Post dose
Post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare the two different products for signal intensity enhancement; average quality of visualization; technical failure rate; to assess inter-reader agreement in terms of average quality of visualization
Time Frame: post dose
post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bracco Diagnostics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 4, 2006

First Submitted That Met QC Criteria

December 4, 2006

First Posted (Estimate)

December 6, 2006

Study Record Updates

Last Update Posted (Estimate)

March 27, 2009

Last Update Submitted That Met QC Criteria

March 25, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH 127

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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