About this trial
Last updated 10 years ago
Study ID
13701
Status
Completed
Type
Interventional
Phase
Phase 4
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 12 years ago
What is this trial about?
Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging
(MRI) scan and injection with a contrast agent, Primovist/Eovist, will be asked to
participate.
The administration of contrast agents that contain gadolinium such as Primovist/Eovist might
increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis
(NSF) in patients with renal impairment. This study is to assess the potential risk to
develop NSF in patients with renal impairment after the administration of Primovist/Eovist.
Patients who are enrolled in this study will receive a Primovist/Eovist enhanced MRI scan
which was prescribed by the referring doctor. After the MRI scan the patient will be included
in a two year follow-up period to assess if signs or symptoms suggestive of NSF have
appeared.
What are the participation requirements?
Inclusion Criteria
- Patient must be scheduled for Contrast enhanced magnetic resonance imaging (CE-MRI) of the liver with Primovist/Eovist based on careful risk/benefit evaluation at the recommended dose in one of the approved indications
- Patient must fulfill criteria for moderate (Estimated glomerular filtration rate [eGFR] 30 - 59 mL/min/1.73 m^2) to severe (eGFR < 30 mL/min/1.73 m^2) renal impairment.
Exclusion Criteria
- Gadolinium based contrast agent (GBCA)-enhanced MRI (or administration of a GBCA for any other CE imaging procedure) other than Primovist/Eovist within 12 months prior to administration of Primovist/Eovist
- History of existing NSF