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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Information provided by:
National Taiwan University Hospital Identifier:
First received: September 8, 2005
Last updated: June 4, 2007
Last verified: June 2005
This trial is to show the diagnostic efficacy of Gadovist for contrast enhanced magnetic resonance angiography (CE-MRA) of the arteries.

Condition Intervention Phase
Angiography, Digital Subtraction Magnetic Resonance Angiography Procedure: CE-MRA Phase 4

Study Type: Interventional
Study Design: 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

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Rate of agreement
  • Image quality
  • Diagnostic confidence

Estimated Enrollment: 40
Study Start Date: June 2005
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information Identifier: NCT00154648     History of Changes
Other Study ID Numbers: 0941540200
Study First Received: September 8, 2005
Last Updated: June 4, 2007

Keywords provided by National Taiwan University Hospital:
angiography processed this record on August 18, 2017