Last updated on January 2020

Long-Term Retention of Gadolinium in Bone


Brief description of study

The purpose of the study is to further investigate the safety of six different commercially used Gadolinium-containing contrast agents.

The study has been developed to evaluate Gadolinium retention in patients with renal function ranging from stable to severely impaired renal function who had previously (i.e. before start of this study) received any of the six different contrast agents within a magnetic resonance contrast imaging procedure and who will now undergo an orthopaedic procedure that allows collection of bone and skin samples for analysis.

Detailed Study Description

The purpose of the study is to further investigate the safety of six different commercially used Gadolinium-containing contrast agents. In order to get a better view of internal organs such as the brain, joints and other body regions contrast agents containing Gadolinium are often administered during magnetic resonance imaging.

Gadolinium-containing contrast agents were introduced in the 1980s, and presently many different products are in common use. Although these agents are well tolerated, in 2006 it was reported that some patients with severe renal failure undergoing magnetic resonance contrast imaging developed signs of a rare condition known as Nephrogenic Systemic Fibrosis (NSF). NSF is an extremely rare disease that has predominantly been reported in patients with severe kidney impairment, acute kidney insufficiency due to the hepatorenal syndrome (kidney failure in patients with advanced chronic liver disease) or in patients with acute kidney insufficiency, who have recently had or soon expect to have a liver transplantation.

In order to collect additional clinical data on a global scale and across different agents in common use, this study was requested by the European Medicines Agency to further investigate whether Gadolinium in human bone and skin are retained for a long time after administration of Gadolinium-containing contrast agents. This study has been developed to evaluate Gadolinium retention in patients with renal function ranging from stable to severely impaired renal function who had previously received any of the six different contrast agents within a magnetic resonance contrast imaging procedure and who are scheduled for an orthopaedic procedure.

For this study the patients will not be administered any research medication.

Participating sites are located in Germany, Italy, Poland, Spain, Turkey, USA, Japan and Republic of Korea.

Clinical Study Identifier: NCT01853163

Recruitment Status: Closed


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