CE-MRA Using Gadovist in Comparison to IA DSA Using Ultravist

June 4, 2007 updated by: National Taiwan University Hospital

An Open, Contrast-Enhanced Magnetic Resonance Angiography (CE-MRA) Study of Arteries Using Gadovist 1.0 in Comparison to Intra-Arterial Digital Subtraction Angiography (IA DSA) Using Ultravist

This trial is to show the diagnostic efficacy of Gadovist for contrast enhanced magnetic resonance angiography (CE-MRA) of the arteries.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This trial is to show the diagnostic efficacy of Gadovist for contrast enhanced Magnetic Resonance Angiography (CE-MRA) of arteries (specified vessel segments) by analyzing the rate of agreement, image quality, and diagnostic confidence between a CE-MRA based diagnosis and the diagnosis achieved from the comparator procedure IA DSA using Ultravist.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

  • Name: Hon-Man Liu, MD
  • Phone Number: 2570 23123456

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Hon-Man Liu, MD
          • Phone Number: 2570 23123456
        • Principal Investigator:
          • Hon-Man Liu, MD
        • Sub-Investigator:
          • Po-Chih Liang, MD

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

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • With suspected or known disease of the arteries
  • Scheduled for an IA DSA/cut film angiography of the arteries in a period of less than 7 days prior to or after the study period and has completed delineation and documentation of all vessels.
  • Willing and able to continue study participation. This includes the administration of Gadovist® 1.0 and completion of all procedures required by the study protocol
  • Patient is between 20 and 75 years of age
  • Fully informed and has signed consent in advance

Exclusion Criteria:

  • Patient is clinically unstable or his/her clinical course during the 72 hour safety observation period was unpredictable
  • Patient with renal failure
  • Woman who is pregnant or of childbearing potential without having had a negative pregnancy test prior to enrollment (within 72 hours prior to CE-MRA)
  • Lactating woman
  • Patient with any contraindication to magnetic resonance imaging (MRI) examination and IA DSA.
  • Patient receives any investigational drug within 30 days prior to study entry or is planned to receive any other investigational drug during the safety follow-up (72 hours after CE-MRA).
  • Patient is scheduled for surgery or other interventions within the 72 hours after the CE-MRA/IA DSA or had any such procedure within 48 hours prior to the study CE-MRA/IA DSA.
  • Hypersensitivity to gadobutrol products
  • Patient has previously entered this study

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: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Image quality
Rate of agreement
Diagnostic confidence

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Hon-Man Liu, MD, National Taiwan University Hospital

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

June 1, 2005

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

June 5, 2007

Last Update Submitted That Met QC Criteria

June 4, 2007

Last Verified

June 1, 2005

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0941540200

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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