Renal safety evaluation after Dotarem®-enhanced-MRI compared with non-enhanced-MRI in patients at high risk of developing contrast medium induced nephropathy

With the common use of contrast media (CM) in diagnostic and interventional procedures, contrast-induced nephropathy (CIN) has become one of the leading cause of hospital acquired acute renal injury. Although CIN has been well studied for iodinated CM, it remains under-investigated for gadolinium-based contrast agents (GBCAs). GBCAs are generally regarded as non-nephrotoxic, but their safety in high-risk patient populations still remains controversial. As of today, there is a lack of prospective studies including control group (i.e. patients not receiving CM) evaluating the influence of GBCAs on CIN incidence. Moreover, mechanisms involved in adverse drug reactions (ADRs) to contrast agents, their characteristics, frequency and risk factors are still a matter of debate. Nevertheless, it has been observed that GBCAs may be responsible for Nephrogenic Systemic Fibrosis (NSF), especially in severe renal impaired patients. The purpose of the study is to prospectively compare the renal safety of meglumine gadoterate (Dotarem®)-enhanced MRI to a control group (unenhanced-MRI) in at-risk patients (with at least moderate renal insufficiency).