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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2005 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00154648
First received: September 8, 2005
Last updated: June 4, 2007
Last verified: June 2005
  Purpose

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: 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

Resource links provided by NLM:


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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00154648

Contacts
Contact: Hon-Man Liu, MD 23123456 ext 2570

Locations
Taiwan
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
Investigators
Principal Investigator: Hon-Man Liu, MD National Taiwan University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00154648     History of Changes
Other Study ID Numbers: 0941540200
Study First Received: September 8, 2005
Last Updated: June 4, 2007
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
MRA
DSA
gadovist
angiography

Additional relevant MeSH terms:
Gadobutrol
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014