Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GE Healthcare
With
i3 Statprobe
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
The subject has been referred for a clinically indicated MRI examination with a gadolinium-based contrast agent.
The subject has known or suspected chronic kidney disease with an eGFR greater than or equal to 30mL and \<60 mL/min/1.73 m2 as measured within 30 days prior to the planned index OMNISCAN administration.
The subject agrees to be contacted for follow-up for 24 months.
You may not be if
Patients with known or suspected NSF based on biopsy confirmation or the onset of signs and symptoms of NSF lasting at least 7 days as follows:
1. skin - swelling, hardening and tightening; reddened or darkened patches; burning or itching;
2. eyes - yellow raised spots on whites of eyes; or
3. bones and muscle - stiffness in joints; difficulty in moving or straightening of arms, hands, legs or feet; bone pain especially in hips and ribs or muscle weakness.
Patients allergic to any GBCA.
Patients with chronic renal disease with a GFR \<30 mL/min/1.73 m2 as measured within 30 days prior to the planned OMNISCAN administration.
Patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri operative liver transplantation period.
Clareo Health | Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)
