Renal Safety Evaluation After Dotarem®-Enhanced MRI

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Although there is a well documented risk of acute renal failure with the iodinated contrast agents, the implication of intravenous gadolinium-based contrast agents in nephrotoxicity remains controversial. The aim of this study was to evaluate the safety profile of gadoterate meglumine (Dotarem®) in patients with chronic renal insufficiency by evaluating the rate of patients experiencing contrast-induced nephrotoxicity following the injection of gadoterate meglumine.

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

Details

• Lead Sponsor: Guerbet
• Treatments: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate

Criteria

Inclusion Criteria:

• Male or female, > or equal 18 years ;

• Patient with a known stable renal insufficiency ;

• Patient scheduled to undergo an MRI examination to specify a diagnosis ;

• Patient able to understand and provide written informed consent to participate in the trial ;

Exclusion Criteria:

• Patient with a contra-indication to MRI ;

• Patient who has a diagnosis of an hemodynamic instability or acute myocardial infarction within 15 days prior the inclusion ;

• Patient who needs hemodialysis ;

• Patient with known allergy to gadolinium chelates ;

• Patient receiving medications known to be nephrotoxic or to cause increases in serum creatinine level within 2 weeks before the inclusion ;

• Patients planned to either undergo surgery or receive chemotherapy ;

• Any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all trial assessments and visits ;

• Patient under guardianship and/or inability or unwillingness to cooperate with the requirements of this trial ;

• Patient with newly discovered unstable diabetes.