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

Magnetic Resonance Angiography Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00154648
• Other study ID #: 0941540200
• Status: Recruiting
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: June 4, 2007
• Start date: June 2005

Study information

• Verified date: June 2005
• Source: National Taiwan University Hospital
• Contact: Hon-Man Liu, MD
• Phone: 23123456
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Angiography, Digital Subtraction
• Magnetic Resonance Angiography

Intervention

Procedure:
• CE-MRA

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of agreement
Primary	Image quality
Primary	Diagnostic confidence