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NCT00447889 Clinical Trial

A Clinical Study of Gadoteric Acid in Non-Coronary Magnetic Resonance (MR) Angiography

Arterial Occlusive Disease Clinical Trial

Official title:
A Clinical Study of Gadoteric Acid in Non-Coronary Magnetic Resonance (MR)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00447889
Other study ID # DGD-44-042
Secondary ID
Status Completed
Phase Phase 4
First received March 14, 2007
Last updated November 25, 2008
Start date March 2006
Est. completion date November 2007

Study information
Verified date November 2008
Source Guerbet
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Interventional

Clinical Trial Summary

This is a clinical study of gadoteric acid in non-coronary MR angiography.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date November 2007
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• gadoteric acid

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Guerbet

Country where clinical trial is conducted

Korea, Republic of, 

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