NCT00154648

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

June 5, 2007

Status Verified

June 1, 2005

First QC Date

September 8, 2005

Last Update Submit

June 4, 2007

Conditions

Angiography, Digital SubtractionMagnetic Resonance Angiography

Keywords

MRADSAgadovistangiography

Outcome Measures

Primary Outcomes (3)

  • Rate of agreement

  • Image quality

  • Diagnostic confidence

Interventions

CE-MRAPROCEDURE

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Study Officials

  • Hon-Man Liu, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hon-Man Liu, MD

CONTACT

23123456

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

June 1, 2005

Last Updated

June 5, 2007

Record last verified: 2005-06

Locations

TW(1)