Harsh Mahajan MD, MBBS, Presenter: Nothing to Disclose

To prospectively assess the safety profile of gadoterate meglumine and the overall incidence of nephrogenic systemic fibrosis (NSF).

An ongoing worldwide multicentre post-marketing study (PMS) is conducted to collect safety data in 40,000 patients (adults and children) with or without renal insufficiency, scheduled to undergo a routine contrast-enhanced magnetic resonance (MR) examination using gadoterate meglumine (Dotarem®). Risk factors at inclusion, indications for MR imaging, conditions of the contrast material administration, occurrence of adverse events are recorded. For any patient identified as renally impaired at the time of inclusion (i.e., estimated creatinine clearance or estimated glomerular filtration rate <60 mL/min/1.73m²), at least a 3-month follow-up is performed in order to detect any suspicion or occurrence of NSF.

As of October 23, 2012, the cut-off date for the interim safety analysis, this ongoing PMS included data on 29689 patients (mean age: 50 years; range: 0-98 years; female, 53.4%). MR examinations were mainly performed to image the central nervous system (55.1%). The main risk factors were renal insufficiency (12.7%) and hypertension (11.8%). Moderate to severe impaired renal function was reported in 552 patients (1.9%). Among them, 391 (70.8%) were reported without suspicion of NSF during the 3-month follow-up. For the remaining patients (29.2%), the follow-up evaluation was not yet reported at the time of data analysis. Twenty-eight patients (<0.1%) had at least one adverse event (mainly nausea, urticaria, vomiting, fever and multiorgan failure syndrome).

This interim safety analysis already confirms the very good safety profile of gadoterate meglumine.

(dealing with safety of contrast enhanced MRI in patients with or without renal insufficiency regarding NSF) this interim safety analysis confirms the very good safety profile of gadoterate meglumine.

Mahajan, H, SECURE Study: Observational Post-marketing Study on the Safety of Gadoterate Meglumine - Interim Analysis.  Radiological Society of North America 2013 Scientific Assembly and Annual Meeting, December 1 - December 6, 2013 ,Chicago IL. http://archive.rsna.org/2013/13022536.html