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
Recruitment status was Recruiting
Sponsor:
National Taiwan University Hospital
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
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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 |
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
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 |
ClinicalTrials.gov processed this record on May 22, 2013