A Safety & Efficacy Clinical Study to Evaluate the Narrowing of the Renal Arteries While Using Gadodiamide
Completed
GE Healthcare
Phase 3
2003-09-01
Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging
(MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow
in the arterial vessels throughout the body.
Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by
directly injecting it into the vein, but this procedure has not been formally tested to image
the renal artery vessels using MR.
The study is designed to determine the presence or absence of a relevant stenosis (ie greater
than/equal to 50%) or occlusion in renal arteries. Intra-arterial Digital Subtraction
Angiography will be used as the standard of truth.
A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-iliac Arteries While Using Gadodiamide
Completed
GE Healthcare
Phase 3
2004-09-01
Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging
(MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow
in the arterial vessels throughout the body.
Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by
directly injecting it into the vein, but this procedure has not been formally tested to image
the aorto-iliac vessels using MR.
The study is designed to determine the presence or absence of a relevant stenosis (ie greater
than/equal to 50%) or occlusion in aorto-iliac arteries. Intra-arterial Digital Subtraction
Angiography (IADSA) will be used as the standard of truth.
Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)
Completed
i3 Statprobe
Phase 4
2009-05-01
This will be an international, multi-center, post-marketing surveillance study in patients
with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI.
Omniscan will be administered intravenously at the medical discretion of the prescribing
physician.
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