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Status unknownNCT00154648Updated Jun 5, 2007

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

A Phase 4 interventional study of CE-MRA in Angiography, Digital Subtraction and Magnetic Resonance Angiography, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-06-05.

Sponsored by National Taiwan University Hospital · Phase 4, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jun 2005), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
20 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Angiography, Digital Subtraction
  • Magnetic Resonance Angiography

Keywords

  • MRA
  • DSA
  • gadovist
  • angiography
03

In context

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Interventions

  • ProcedureCE-MRA
06

What researchers measure

Primary outcomes

  1. Rate of agreement

  2. Image quality

  3. Diagnostic confidence

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, Taiwan
    • Hon-Man Liu, MD · Contact · 23123456
    • Hon-Man Liu, MD · Principal investigator
    • Po-Chih Liang, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00154648
Lead sponsor
National Taiwan University Hospital
First posted
Sep 12, 2005
Start date
Jun 2005
Last update
Jun 5, 2007

Study contacts

Hon-Man Liu, MD
Contact
23123456 ext. 2570
Hon-Man Liu, MD
principal investigator · National Taiwan University Hospital
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2005. You cannot join it, but the record below documents what was studied.

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