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

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guerbet

Criteria

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.