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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00154648
Recruitment Status : Unknown
Verified June 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : June 5, 2007
Information provided by:
National Taiwan University Hospital

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

Condition or disease Intervention/treatment Phase
Angiography, Digital Subtraction Magnetic Resonance Angiography Procedure: CE-MRA Phase 4

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : June 2005

Primary Outcome Measures :
  1. Rate of agreement
  2. Image quality
  3. Diagnostic confidence

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00154648

Contact: Hon-Man Liu, MD 23123456 ext 2570

National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Hon-Man Liu, MD    23123456 ext 2570      
Principal Investigator: Hon-Man Liu, MD         
Sub-Investigator: Po-Chih Liang, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Hon-Man Liu, MD National Taiwan University Hospital Identifier: NCT00154648     History of Changes
Other Study ID Numbers: 0941540200
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: June 5, 2007
Last Verified: June 2005

Keywords provided by National Taiwan University Hospital: