- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00447889
A Clinical Study of Gadoteric Acid in Non-Coronary Magnetic Resonance (MR) Angiography
November 25, 2008 updated by: Guerbet
A Clinical Study of Gadoteric Acid in Non-Coronary Magnetic Resonance (MR)
This is a clinical study of gadoteric acid in non-coronary MR angiography.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of
- Asan Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female, at least the age of legal maturity
- Strongly suspected of having non-coronary arterial disease, detected clinically
- Scheduled to undergo x-ray angiography examination
- Female patients must be using effective contraception or be surgically sterilized or post-menopausal.
- Females of childbearing potential must have a documented negative urine pregnancy test.
Exclusion Criteria:
- Contraindication to magnetic resonance imaging (MRI)
- Any metallic medical device in the vascular territory for which the patient is to undergo imaging examinations
- Congenital morphologic vascular abnormalities
- Known allergy to gadolinium chelates
- Pregnant, breast feeding, or planning to become pregnant during the trial
- Received a gadolinium complex within 2 days or iron oxide nanoparticles within 7 days before the gadoteric acid-enhanced magnetic resonance angiography (MRA) examination.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Corinne Dubourdieu, PhD, Guerbet
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
March 14, 2007
First Submitted That Met QC Criteria
March 14, 2007
First Posted (Estimate)
March 15, 2007
Study Record Updates
Last Update Posted (Estimate)
November 26, 2008
Last Update Submitted That Met QC Criteria
November 25, 2008
Last Verified
November 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DGD-44-042
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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